albuterol and Fractures, Bone

albuterol has been researched along with Fractures, Bone in 3 studies

Albuterol: A short-acting beta-2 adrenergic agonist that is primarily used as a bronchodilator agent to treat ASTHMA. Albuterol is prepared as a racemic mixture of R(-) and S(+) stereoisomers. The stereospecific preparation of R(-) isomer of albuterol is referred to as levalbuterol.
albuterol : A member of the class of phenylethanolamines that is 4-(2-amino-1-hydroxyethyl)-2-(hydroxymethyl)phenol having a tert-butyl group attached to the nirogen atom. It acts as a beta-adrenergic agonist used in the treatment of asthma and chronic obstructive pulmonary disease (COPD).

Fractures, Bone: Breaks in bones.

Research

Studies (3)

Authors

Clinical Trials (5)

Trial Overview

Trial Outcomes

Change From Baseline in FEV1 AUC(0-12h) Normalized by Time at Week 6

"Change from baseline in FEV1 AUC(0-12h), normalized by time, at the end of treatment (Week 6).~Spirometry, used to measure FEV1, was performed according to internationally accepted standards. The AUC for FEV1 at Week 6 of treatment was calculated by using the linear trapezoidal rule, based on the changes in FEV1 from the baseline values, and divided by the observation time (12 hours).~Definitions:~AUC=Area under the curve; Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose), at Visit 2 (Week 0); FEV1=Forced expiratory volume in the 1st second; FEV1 AUC(0-12h)=Mean FEV1 after inhalation, measured at prespecified times for up to 12-h observation period (0-12 h), normalized by time;" (NCT03084796)
Timeframe: Baseline, Week 6

Change From Baseline in FEV1 AUC(0-12h) Normalized by Time on Day 1

"Change from baseline in FEV1 AUC(0-12h), normalized by time, on Day 1.~Spirometry, used to measure FEV1, was performed according to internationally accepted standards. The AUC for FEV1 on Day 1 of treatment was calculated by using the linear trapezoidal rule, based on the changes in FEV1 from the baseline values, and divided by the observation time (12 hours).~Definitions:~AUC=Area under the curve; Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose), at Visit 2 (Week 0); Day 1=Day of the first dose of randomized study drug at Visit 2 (Week 0); FEV1=Forced expiratory volume in the 1st second; FEV1 AUC(0-12h)=Mean FEV1 after inhalation, measured at prespecified times for up to 12-h observation period (0-12 h), normalized by time;" (NCT03084796)
Timeframe: Baseline, Day 1

Number of Patients Achieving Onset of Action - Change From Baseline in Post-dose FEV1 ≥100 mL on Day 1

Number of patients achieving onset of action was defined as a change from baseline in post-dose FEV1 ≥100 mL on Day 1. These are the patients who contributed to the results, reported as median and 95% CI for 'time to onset of action' presented in Outcome Measure 8, above. (NCT03084796)
Timeframe: Day 1

Time to Onset of Action (Change From Baseline in Post-dose FEV1 ≥ 100 mL) on Day 1

Time to onset of action is defined as the time (in minutes) from receiving the study drug on Day 1, until the FEV1 change from baseline is ≥100 mL. (NCT03084796)
Timeframe: Day 1

Change From Baseline in 24-Hour Holter Electrocardiogram (ECG) Parameters - Fridericia-corrected QT Interval (QTcF)

"Change from baseline in 24-Hour Holter electrocardiogram (ECG) parameters - Fridericia-corrected QT interval (QTcF).~Subjects had a 24-h Holter recording before and 24 h after the 1st dose of study drug (Visit 2) and for 24 h before the last dose of study drug (Visit 4). The time-matched values recorded during the 24 h before the 1st dose of study drug on Visit 2 and served as the baseline for the Holter-extracted ECG parameters. The time-averaged baseline score is the average of the Day -1 scores at +5 min, +55 min, and at +2.5 h." (NCT03084796)
Timeframe: Baseline, Day 1, Week 6

Change From Baseline in 24-Hour Holter Electrocardiogram (ECG) Parameters - Heart Rate (HR)

"Change from baseline in 24-Hour Holter electrocardiogram (ECG) parameters - Heart rate (HR)~Subjects had a 24-h Holter recording before and 24 h after the 1st dose of study drug (Visit 2) and for 24 h before the last dose of study drug (Visit 4). The time-matched values recorded during the 24 h before the 1st dose of study drug on Visit 2 and served as the baseline for the Holter-extracted ECG parameters. The time-averaged baseline score is the average of the Day -1 scores at +5m, +55m, and at +2.5 h." (NCT03084796)
Timeframe: Baseline, Day 1, Week 6

Change From Baseline in 24-Hour Holter Electrocardiogram (ECG) Parameters - PR Interval

"Change from baseline in 24-Hour Holter electrocardiogram (ECG) parameters - PR Interval~Subjects had a 24-h Holter recording before and 24 h after the 1st dose of study drug (Visit 2) and for 24 h before the last dose of study drug (Visit 4). The time-matched values were recorded during the 24 h before the 1st dose of study drug on Visit 2 and served as the baseline for the Holter-extracted ECG parameters. The time-averaged baseline score is the average of the Day -1 scores at +5 min, +55 min, and at +2.5 h." (NCT03084796)
Timeframe: Baseline, Day 1, Week 6

Change From Baseline in 24-Hour Holter Electrocardiogram (ECG) Parameters - QRS Interval

"Change from baseline in 24-Hour Holter electrocardiogram (ECG) parameters - QRS Interval~Subjects had a 24-h Holter recording before and 24 h after the 1st dose of study drug (Visit 2) and for 24 h before the last dose of study drug (Visit 4). The time-matched values were recorded during the 24 h before the 1st dose of study drug on Visit 2 and served as the baseline for the Holter-extracted ECG parameters. The time-averaged baseline score is the average of the Day -1 scores at +5 min, +55 min, and at +2.5 h." (NCT03084796)
Timeframe: Baseline, Day 1, Week 6

Change From Baseline in Average EXACT-Respiratory Symptom (E-RS) Total Score During Inter-Visit Periods and the Entire Treatment Period

"Change from baseline in average EXACT-Respiratory Symptom (E-RS) total score during inter-visit periods and the entire treatment period~E-RS in COPD uses 11 respiratory symptom items from the 14-item EXAcerbations of COPD tool (EXACT). E-RS total score quantifies respiratory symptom severity on a scale ranging from 0 to 40. Higher E-RS total scores indicate more severe symptoms and a declining total score indicates health improvement. E-RS questionnaire was completed by the patient each evening (e-diary).~Definitions:~For details on baseline, inter-visit periods, and the entire treatment period, please refer to outcome measure #15." (NCT03084796)
Timeframe: Baseline, Inter-visit period 1, Inter-visit period 2, Entire treatment period

Change From Baseline in Average Use of Rescue Medication During Inter-Visit Periods and the Entire Treatment Period

"Evaluate the change from baseline in average use of rescue medication (number of puffs/day) during the inter-visit periods and the entire treatment period.~Results are shown as number of puffs/day; a decrease (implies improvement) from baseline in average use of rescue medication.~Definitions:~Baseline=Data recorded during the run-in period (a 2-week period prior to randomization to study treatment and study drug intake); Inter-visit period 1=Starts at randomization to treatment (Visit 2, Week 0) and runs to the day before the subject returns to the clinic (Visit 3 (Week 3); Inter-visit period 2=Starts when the subject returns to the clinic (Visit 3, Week 3) and runs to the end of the randomized treatment period (Visit 4, Week 6); Entire Treatment period=From day of randomization to drug intake to the end of the randomized treatment period (Visit 4, Week 6); Randomization=Randomization to study drug treatment (Visit 2, Week 0);" (NCT03084796)
Timeframe: Baseline, Inter-visit period 1, Inter-visit period 2, Entire treatment period

Change From Baseline in FEV1 AUC(0-4h) Normalized by Time on Day 1 and at Week 6

"Change from baseline in FEV1 AUC(0-4h), normalized by time on Day 1 of treatment (Week 0).~Spirometry, used to measure FEV1, was performed according to internationally accepted standards. The AUC for FEV1 on Day 1 and at Week 6 of treatment was calculated by using the linear trapezoidal rule, based on the changes in FEV1 from the baseline values, and divided by the observation time (4 hours).~Definitions:~AUC=Area under the curve; Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose), at Visit 2 (Week 0); Day 1=Day of the first dose of randomized study drug at Visit 2 (Week 0); FEV1=Forced expiratory volume in the 1st second; FEV1 AUC(0-4h)=Mean FEV1 after inhalation, measured at prespecified times for up to 4-h observation period (0-4h), normalized by time;" (NCT03084796)
Timeframe: Baseline, Day 1, Week 6

Change From Baseline in FEV1 Peak(0-4h) at Day 1 and Week 6

"Change from baseline in FEV1 peak(0-4h) (L) on Day 1 and at Week 6.~Peak FEV1 is defined as the maximum FEV1 observed in the first 4 hours after dose of study medication.~Definitions:~Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose), at Visit 2 (Week 0); Day 1=Day of the first dose of randomized study drug at Visit 2 (Week 0); FEV1=Forced expiratory volume in the 1st second; Peak(0-4h)=Maximum FEV1 between 0 and 4 h." (NCT03084796)
Timeframe: Baseline, Day 1, Week 6

Change From Baseline in FVC AUC(0-12h), Normalized by Time on Day 1 and at Week 6

"Change from baseline in FVC AUC(0-12h), normalized by time, on Day 1 and at the end of treatment (Week 6).~Spirometry, used to measure FVC, was performed according to internationally accepted standards. The AUC for FVC was calculated by using the linear trapezoidal rule, based on the changes in FVC from the baseline values, and divided by the observation time (4 hours).~Definitions:~AUC=Area under the curve; Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose), at Visit 2 (Week 0); Day 1=Day of the first dose of randomized study drug at Visit 2 (Week 0); FVC=Forced Vital Capacity; FVC AUC(0-12h)=Mean FVC after inhalation, measured at prespecified times for up to 12-h observation period (0-12 h), normalized by time;" (NCT03084796)
Timeframe: Baseline, Day 1, Week 6

Change From Baseline in FVC AUC(0-4h) Normalized by Time on Day 1 and at Week 6

"Change from baseline in FVC AUC(0-4h), normalized by time, on Day 1 and at the end of treatment (Week 6).~Spirometry, used to measure FVC, was performed according to internationally accepted standards. The AUC for FVC was calculated by using the linear trapezoidal rule, based on the changes in FVC from the baseline values, and divided by the observation time (4 hours).~Definitions:~AUC=Area under the curve; Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose), at Visit 2 (Week 0); Day 1=Day of the first dose of randomized study drug at Visit 2 (Week 0); FVC=Forced Vital Capacity; FVC AUC(0-4)=Mean FVC after inhalation, measured at prespecified times for up to 4-h observation period (0-4 h), normalized by time;" (NCT03084796)
Timeframe: Baseline, Day 1, Week 6

Change From Baseline in FVC Peak(0-4h) on Day 1 and at Week 6

"Change from baseline in FVC peak(0-4h) (L) on Day 1 and at the end of treatment at Week 6. Peak FEV1 is defined as the maximum FEV1 observed in the first 4 hours after dose of study medication.~Definitions:~Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose), at Visit 2 (Week 0); Day 1=Day of the first dose of randomized study drug at Visit 2 (Week 0); FVC=Forced Vital Capacity; Peak(0-4h)=Maximum FEV1 between 0 and 4 h." (NCT03084796)
Timeframe: Baseline, Day 1, Week 6

Change From Baseline in Percentage of Rescue Medication-Free Days During Inter-Visit Periods and the Entire Treatment Period

"Evaluate the number of rescue medication-free days compared with baseline. Results are shown as percentage (%) of rescue medication-free days; an increased value indicates improvement from baseline.~Definitions:~Baseline=Data recorded during the run-in period (a 2-week period prior to randomization to study treatment and study drug intake); Inter-visit period 1=Starts at randomization to treatment (Visit 2, Week 0) and runs to the day before the subject returns to the clinic (Visit 3, Week 3); Inter-visit period 2=Starts when the subject returns to the clinic (Visit 3, Week 3) and runs to the end of the randomized treatment period (Visit 4, Week 6); Entire Treatment period=From day of randomization to drug intake to the end of the randomized treatment period (Visit 4, Week 6); Randomization=Randomization to study drug treatment (Visit 2, Week 0)." (NCT03084796)
Timeframe: Baseline, Inter-visit period 1, Inter-visit period 2, Entire treatment period

Change From Baseline in Pre-dose Morning FEV1 at Week 3 and Week 6

"Change from baseline in FEV1 at treatment visit 3 (Week 3) and treatment visit 4 (Week 6) of treatment. Spirometry, used to measure FEV1, was performed according to internationally accepted standards.~Definitions:~Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose), at Visit 2 (Week 0); FEV1=Forced expiratory volume in the 1st second;" (NCT03084796)
Timeframe: Baseline, Week 3, Week 6

Change From Baseline in Pre-Dose Morning Inspiratory Capacity (IC) at Week 3 and Week 6

"Change from baseline in IC at treatment Visit 3 (Week 3) and treatment Visit 4 (Week 6). Spirometry was used to measure IC and was performed according to internationally accepted standards.~Definitions:~Baseline: value of the measurement recorded at 45 mins pre-dose at Visit 2 (Week 0); IC=Inspiratory capacity;" (NCT03084796)
Timeframe: Baseline, Week 3, Week 6

Transition Dyspnea Index (TDI) Focal Score at Week 3 and Week 6

"Transitional Dyspnea Index (TDI) focal score at treatment visit 3 (Week 3) and treatment visit 4 (Week 6).~TDI is a validated, interviewer-administered questionnaire that measures changes in dyspnea severity from the baseline established by the BDI questionnaire. TDI consists of the same 24 items and 3 domains as the BDI, with the same 2-week recall period. Each category is rated by 7 grades ranging from -3 (major deterioration) to +3 (major improvement), with a total score ranging from -9 to +9, with higher scores indicating better outcomes. The minimal clinically important differences (MCID) is considered a change of ≥1 unit. The same investigator or designee interviewed the subject for the BDI and TDI during the study period. A TDI focal score of ≥1 is considered as clinically important.~Definitions:~Baseline=The BDI focal score value at Visit 2 (Week 0); BDI=Baseline Dyspnea Index; MCID=Minimal Clinically Important Differences; TDI=Transition Dyspnea Index;" (NCT03084796)
Timeframe: Baseline, Week 3, Week 6

Transition Dyspnea Index (TDI) Response (Focal Score ≥1) at Week 3 and Week 6

"Number of subjects achieving TDI focal score ≥1, at treatment visit 3 (Week 3) and at treatment visit 4 (Week 6).~TDI is a validated, interviewer-administered questionnaire that measures changes in dyspnea severity from the baseline established by the BDI questionnaire. TDI consists of the same 24 items and 3 domains as the BDI, with the same 2-week recall period. Each category is rated by 7 grades ranging from -3 (major deterioration) to +3 (major improvement); total score ranging from -9 to +9, with higher scores indicating better outcomes. The minimal clinically important differences (MCID) is considered a change of ≥1 unit. The same investigator or designee interviewed the subject for the BDI and TDI during the study period. A TDI focal score of ≥1 is considered as clinically important.~Definitions:~Baseline=The BDI focal score value at Visit 2 (Week 0); BDI=Baseline Dyspnea Index; MCID=Minimal Clinically Important Differences; TDI=Transition Dyspnea Index;" (NCT03084796)
Timeframe: Baseline, Week 3, Week 6

Vital Signs -- Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP)

"Vital signs -- Systolic blood pressure (SBP), Diastolic blood pressure (DBP) were measured at prespecified times, using a 12-Lead single ECGs were recorded at all study visits (pre-dose at V1 (Week -2) and V3 (Week 3), as well as at pre-dose and 1.5 hours post-dose at Visit 2 (Week 0) and Visit 4 (Week 6).~Results are shown by treatment group, as change from baseline (in mmHg) for representative timepoints.~Definitions:~Baseline=Values recorded pre-dose (Visit 2, Week 0); Day 1=Day of the first dose of randomized study drug (Visit 2, Week 0);" (NCT03084796)
Timeframe: Baseline, Day 1, Week 6

24-hour Holter ECG - Prolonged QTcF - Change From Baseline

"24-hour Holter ECG - Prolonged QTcF - Change from baseline.~Subjects had a 24-h Holter recording before and 24 h after the 1st dose of study drug (Visit 2) and for 24 h before the last dose of study drug (Visit 4). The time-matched values recorded during the 24 h before the 1st dose of study drug on Visit 2 and served as the baseline for the Holter-extracted ECG parameters. The time-averaged baseline score is the average of the Day -1 scores at +5 min, +55 min, and at +2.5 h.~Results are presented as the number of subjects who had a change from baseline in QTcF of: > 30 msec, > 60 msec, and no prolongation (by > 30 msec or > 60 msec)." (NCT03084796)
Timeframe: Baseline, Day 1, Week 6

24-hour Holter ECG - Prolonged QTcF - Female Subjects

"24-hour Holter ECG - Prolonged QTcF - Female subjects.~Subjects had a 24-h Holter recording before and 24 h after the 1st dose of study drug (Visit 2) and for 24 h before the last dose of study drug (Visit 4). The time-matched values recorded during the 24 h before the 1st dose of study drug on Visit 2 and served as the baseline for the Holter-extracted ECG parameters. The time-averaged baseline score is the average of the Day -1 scores at +5 min, +55 min, and at +2.5 h." (NCT03084796)
Timeframe: Baseline, Day 1, Week 6

24-hour Holter ECG - Prolonged QTcF - Male Subjects

"24-hour Holter ECG - Prolonged QTcF - Male subjects.~Subjects had a 24-h Holter recording before and 24 h after the 1st dose of study drug (Visit 2) and for 24 h before the last dose of study drug (Visit 4). The time-matched values recorded during the 24 h before the 1st dose of study drug on Visit 2 and served as the baseline for the Holter-extracted ECG parameters. The time-averaged baseline score is the average of the Day -1 scores at +5 min, +55 min, and at +2.5 h." (NCT03084796)
Timeframe: Baseline, Day 1, Week 6

12-lead ECG Parameters - Heart Rate - Change From Baseline

"12-lead electrocardiogram (12-lead ECG) parameter - heart rate (HR) was measured at baseline (Day 1) and Week 8.~Change from baseline.~Definitions:~Baseline=Baseline values were defined at visit 2 (Week 0) pre-dose;~bpm=Beats per minute;" (NCT03084718)
Timeframe: Baseline, Week 8

24-hr Creatinine - Change From Baseline.

"24-hr Creatinine - Change From Baseline.~For the evaluation of the 24-hr creatinine excretion, 24-hour urine sample were collected. Creatinine was measured using liquid chromatography-tandem mass spectrometry (LC-MS/MS).~Definitions:~Baseline=Baseline values were defined at visit 2 (Week 0) pre-dose;" (NCT03084718)
Timeframe: Baseline, Week 8

24-hr Urine Free Cortisol - Change From Baseline

"24-hr Urinary Free Cortisol - Change From Baseline.~For the evaluation of the 24-hr Urine-Free cortisol excretion, 24-hour urine samples were collected. Urine-free cortisol was measured using liquid chromatography-tandem mass spectrometry (LC-MS/MS).~Definitions:~Baseline=Baseline values were defined at visit 2 (Week 0) pre-dose;" (NCT03084718)
Timeframe: Baseline, Week 8

Pre-dose Morning FEV1 at Week 4 - Change From Baseline

"Change from baseline in pre-dose morning FEV1 at Week 4.~Spirometry, used to measure FEV1, was performed according to internationally accepted standards.~Definitions:~Baseline=Baseline values for pre-dose FEV1 were the average of measurements taken at V2 (Week 0) at 45 minutes and 15 minutes pre-dose; FEV1=Forced expiratory volume in the 1st second;" (NCT03084718)
Timeframe: Baseline, Week 4

Pre-dose Morning FEV1 at Week 8 - Change From Baseline

"Change from baseline in pre-dose morning FEV1 (average of pre-dose FEV1 measurements) at Week 8.~Spirometry, used to measure FEV1, was performed according to internationally accepted standards.~Definitions:~Baseline=Baseline values for pre-dose FEV1 were the average of measurements taken at V2 (Week 0) at 45 minutes and 15 minutes pre-dose; FEV1=Forced expiratory volume in the 1st second;" (NCT03084718)
Timeframe: Baseline, Week 8

12-lead ECG Parameters - PR, QRS, QTcF - Change From Baseline.

"12-lead electrocardiogram (12-lead ECG) parameters - PR, QRS, QTcF intervals - were measured at baseline (Day 1) and Week 8.~Changes from baseline.~Definitions:~Baseline=Baseline values were defined at visit 2 (Week 0); QTcF=Fridericia-corrected QT interval; msec=Millisecond;" (NCT03084718)
Timeframe: Baseline, Week 8

12-lead ECG Parameters - Prolonged QTcF - Change From Baseline

"Number of participants with prolonged QTcF. Change from baseline.~Baseline=Baseline values were defined at visit 2 (Week 0) pre-dose; QTcF=Fridericia-corrected QT interval;" (NCT03084718)
Timeframe: Baseline, Week 8

Asthma Control Questionnaire-7© (ACQ-7) Score at Week 4 and Week 8 - Change From Baseline

"The ACQ consists of 7 items: 6 simple self-administered questions referring to asthma control and rescue treatment usage with 1 week recall, and a 7th item consisting of the percent (%) predicted FEV1 completed by clinic staff. Scoring uses a 7-point scale: 0 = totally controlled and 6 = severely uncontrolled. The ACQ score was calculated as the average of all 7 items.~Definitions:~ACQ-7 score=Asthma Control Questionnaire-7©; Information regarding the American Thoracic Society ACQ questionnaire is also available at: https://member.thoracic.org/members/assemblies/assemblies/srn/questionaires/acq.php; Baseline ACQ-7 score = ACQ score recorded at V2 (Week 0) Day 1, before randomization; FEV1=Forced expiratory volume in the 1st second;" (NCT03084718)
Timeframe: Baseline, Week 4, Week 8

Average Use of Rescue Medication - Change From Baseline

"Change from baseline in average use of rescue medication, during Inter-visit period 1, Inter-visit period 2, Entire treatment period.~Definitions:~Baseline=For the efficacy variable -- average use of rescue medication -- derived from the electronic diary (eDiary), baseline values were the averages recorded during the run-in period;~Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4);~Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8);~Entire treatment period=Average of 8 weeks;~am=morning pm=evening" (NCT03084718)
Timeframe: Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)

Overall Daily Asthma Symptoms Scores - Change From Baseline

"Overall daily asthma symptoms scores - Change From Baseline (am and pm).~Subjects had to record asthma symptom score (overall symptoms, cough, wheeze, chest tightness and breathlessness) in the am (night-time asthma symptom score) and in the pm (daytime asthma symptom score). These data were collected in the subject's diary. Daily asthma symptoms score were performed separately for am score and pm score and also as a total, where the total equals the sum of the am and pm scores. Degree of asthma symptoms by score: 0=None, 1=Mild, 2=Moderate, and 3=Severe.~Baseline=Averages values during the run-in period;~Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4);~Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8);~Entire treatment period=Average of 8 weeks;~am=morning pm=evening" (NCT03084718)
Timeframe: Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)

Percentage (%) of Asthma Control Days - Change From Baseline

"Change from baseline in percentage (%) of asthma control days, during Inter-visit period 1, Inter-visit period 2, Entire treatment period.~This outcome measure was calculated according to the following definition: Days with a total daily morning + evening asthma score = 0 AND No rescue medication use.~Definitions:~Baseline=For the efficacy variable -- asthma control days -- derived from the eDiary, baseline values were the averages/percentages recorded during the run-in period;~Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4);~Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8);~Entire treatment period=Average of 8 weeks;~am=morning pm=evening" (NCT03084718)
Timeframe: Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)

Percentage (%) of Asthma Symptoms-free Days - Change From Baseline

"Change from baseline in Percentage (%) of asthma symptoms-free days.~Asthma symptoms-free days is the number of days with a total asthma score=0 (daily morning plus evening asthma score).~Subjects recorded asthma symptom score as described in the Outcome measure #7.~Definitions:~Baseline=For the efficacy variables -- daytime and night-time asthma symptom scores -- derived from the eDiary, baseline values were the averages/percentages recorded during the run-in period;~Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4);~Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8);~Entire treatment period=Average of 8 weeks;~am=morning pm=evening" (NCT03084718)
Timeframe: Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)

Percentage (%) of Rescue Medication-free Days - Change From Baseline

"Change from baseline in percentage (%) of rescue medication-free days. An increased value indicates improvement from baseline.~Definitions:~Baseline=For the efficacy variable -- percentage (%) of rescue medication-free days -- derived from the electronic diary (eDiary), baseline values were the averages/percentages recorded during the run-in period.~Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4);~Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8);~Entire treatment period=Average of 8 weeks;~am=morning pm=evening" (NCT03084718)
Timeframe: Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)

Pre-dose Morning FVC at Week 4 and 8 - Change From Baseline

"Change from baseline in pre-dose morning FVC at Week 4 and 8.~Spirometry, used to measure FVC, was performed according to internationally accepted standards.~Definitions:~Baseline=Baseline values for pre-dose FVC were the average of measurements taken at V2 (Week 0) at 45 minutes and 15 minutes pre-dose; FVC=Forced vital capacity;" (NCT03084718)
Timeframe: Baseline, Week 4, Week 8

Pre-dose Peak Expiratory Flow (PEF) (L/Min) (Morning and Evening) - Change From Baseline

"Change from baseline in pre-dose Peak Expiratory Flow (PEF) (Liters/min), morning and evening measurements.~Definitions:~Baseline=For the efficacy variable -- morning and evening PEF -- derived from the eDiary, the baseline values were the averages/percentages recorded during the run-in period; PEF=evening peak expiratory flow;~Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4);~Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8);~Entire treatment period=Average of 8 weeks;~am=morning pm=evening" (NCT03084718)
Timeframe: Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)

Vital Signs (Systolic and Diastolic Blood Pressure) - Change From Baseline

"Vital signs (systolic and diastolic blood pressure) at baseline, week 4, and week 8.~Change from baseline.~Definitions:~Baseline=Baseline values were defined at visit 2 (Week 0) pre-dose; DBP=Diastolic blood pressure; SBP=Systolic blood pressure;" (NCT03084718)
Timeframe: Baseline, Week 4, Week 8

FEV1 Area Under the Curve Between 0 and 12 h [AUC(0-12h)], Normalized by Time -- Change From Baseline to Post Dose Day 14

"Spirometry used to measure FEV1, was performed according to internationally accepted standards. Results show the change from baseline in FEV1 AUC(0-12h), normalized by time on Day 14; it was calculated by using the linear trapezoidal rule, based on the changes in FEV1 from the baseline values.~Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended).~Definitions:~AUC=Area under the curve; AUC(0-12h)=AUC between 0 and 12 h; Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose) on Day 1 of the treatment period; FEV1=Forced expiratory volume in the 1st second;" (NCT03086460)
Timeframe: Baseline, Day 14 post-dose

FEV1 AUC(0-12h), Normalized by Time -- Change From Baseline to Post Dose Day 1

"Spirometry used to measure FEV1, was performed according to internationally accepted standards.~Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended).~Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose) on Day 1 of the treatment period;" (NCT03086460)
Timeframe: Baseline, Day 1 post-dose

Patients Achieving Onset of Action -- Change From Baseline in Post-dose FEV1 ≥12% and ≥200 mL to Post Dose Day 1

"Patients achieving onset of action, defined as a change from baseline in post-dose FEV1 ≥12% and ≥200 mL, on Day 1. These are the subjects who contributed to the results, reported as median and 95% CI for 'Time to onset of action' presented in the Outcome Measure 13, above.~For patients receiving the same treatment twice, the analysis includes only data from the first instance of each treatment.~Definitions:~Onset of action=Change from baseline in post-dose FEV1 ≥12% and ≥200 mL; Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose);" (NCT03086460)
Timeframe: Baseline, Day 1 post-dose

Pre-dose Morning FEV1 (L) -- Change From Baseline to Post Dose Day 14

"Spirometry, used to measure FEV1, was performed according to internationally accepted standards.~Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended).~Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose) on Day 1 of the treatment period;" (NCT03086460)
Timeframe: Baseline, Day 14 post-dose

Pre-dose Morning FVC -- Change From Baseline to Post Dose Day 14

"Spirometry, used to measure FVC, was performed according to internationally accepted standards.~Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended).~Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose) on Day 1 of the treatment period;" (NCT03086460)
Timeframe: Baseline, Day 14 post-dose

Sensitivity Analysis 1: FEV1 AUC(0-12h), Normalized by Time -- Change From Baseline to Post Dose Day 14

"The primary analysis was repeated, considering patients as randomized and including only the first instance of each treatment.~Patients receiving the same treatment in more than one period were included in the analysis with only data from the first instance of each treatment." (NCT03086460)
Timeframe: Baseline, Day 14 post-dose

Sensitivity Analysis 2: FEV1 AUC(0-12h), Normalized by Time -- Change From Baseline to Post Dose Day 14

"The primary analysis was repeated, considering only patients and treatment periods for which treatment was assigned on or after the randomization error occurred.~The number of patients shown represents those with at least one post-baseline assessment available." (NCT03086460)
Timeframe: Baseline, Day 14 post-dose

Sensitivity Analysis 3: FEV1 AUC(0-12h), Normalized by Time -- Change From Baseline to Post Dose Day 14

"Patients receiving the same treatment during two treatment periods are considered twice in the ANCOVA model (once for each period attended).~Patients considered in this analysis are those with at least one available post-baseline assessment." (NCT03086460)
Timeframe: Baseline, Day 14 post-dose

Time to Onset of Action -- Change From Baseline in Post-dose FEV1 ≥12% and ≥200 mL to Post Dose Day 1

"Spirometry, used to measure FEV1, was performed according to internationally accepted standards.~For patients receiving the same treatment twice, the analysis includes only data from the first instance of each treatment.~Definitions:~Time to onset of action=The time (in minutes) from receiving the study drug on Day 1, until the FEV1 change from baseline is ≥200 mL; Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose) on Day 1 of the treatment period;" (NCT03086460)
Timeframe: Baseline, Day 1 post-dose

12-lead ECG Parameter -- Heart Rate (HR) -- Change From Baseline Post-dose to Post Dose Day 1 and Day 14

"Results are shown by treatment group, as change from baseline (in bpm).~For patients receiving the same treatment in 2 periods, the average of the 2 available data points was considered in the calculation.~For safety variables, the baseline for each period was defined as pre-dose measurements on Day 1 of each treatment period." (NCT03086460)
Timeframe: Baseline, Day 1, Day 14 post-dose

12-lead Electrocardiogram (ECG) Parameter (PR Interval) -- Change From Baseline Post-dose to Post Dose Day 1 and Day 14

"12-lead electrocardiogram (ECG) parameters were monitored during the study. Results are shown by treatment group, as change from baseline (in msec).~For patients receiving the same treatment in 2 periods, the average of the 2 available data points was considered in the calculation.~For safety variables, the baseline for each period was defined as pre-dose measurements on Day 1 of each treatment period." (NCT03086460)
Timeframe: Baseline, Day 1, Day 14 post-dose

12-lead Electrocardiogram (ECG) Parameter (QRS Interval) -- Change From Baseline Post-dose to Post Dose Day 1 and Day 14

"12-lead electrocardiogram (ECG) parameters were monitored during the study. Results are shown by treatment group, as change from baseline (in msec).~For patients receiving the same treatment in 2 periods, the average of the 2 available data points was considered in the calculation.~For safety variables, the baseline for each period was defined as pre-dose measurements on Day 1 of each treatment period." (NCT03086460)
Timeframe: Baseline, Day 1, Day 14 post-dose

12-lead Electrocardiogram (ECG) Parameter (QTcF Interval) -- Change From Baseline Post-dose to Post Dose Day 1 and Day 14

"12-lead electrocardiogram (ECG) parameters were monitored during the study. Results are shown by treatment group, as change from baseline (in msec).~For patients receiving the same treatment in 2 periods, the average of the 2 available data points was considered in the calculation.~For safety variables, the baseline for each period was defined as pre-dose measurements on Day 1 of each treatment period." (NCT03086460)
Timeframe: Baseline, Day 1, Day 14 post-dose

FEV1 AUC(0-4h), Normalized by Time -- Change From Baseline to Post Dose Day 1 and Day 14

"Spirometry used to measure FEV1, was performed according to internationally accepted standards.~Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended).~Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose) on Day 1 of the treatment period;" (NCT03086460)
Timeframe: Baseline, Day 1, Day 14 post-dose

FEV1 Peak(0-4h), Normalized by Time -- Change From Baseline to Post Dose Day 1 and Day 14

"Spirometry, used to measure FEV1, was performed according to internationally accepted standards.~Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended).~Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose) on Day 1 of the treatment period;" (NCT03086460)
Timeframe: Baseline, Day 1, Day 14 post-dose

FVC AUC(0-12h), Normalized by Time -- Change From Baseline to Post Dose Day 1 and Day 14

"Spirometry, used to measure FVC, was performed according to internationally accepted standards.~Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended).~Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose) on Day 1 of the treatment period;" (NCT03086460)
Timeframe: Baseline, Day 1, Day 14 post-dose

FVC AUC(0-4h), Normalized by Time -- Change From Baseline to Post Dose Day 1 and Day 14

"Spirometry, used to measure FVC, was performed according to internationally accepted standards.~Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended).~Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose) on Day 1 of the treatment period;" (NCT03086460)
Timeframe: Baseline, Day 1, Day 14 post-dose

FVC Peak(0-4h), Normalized by Time -- Change From Baseline to Post Dose Day 1 and Day 14

"Spirometry, used to measure FVC, was performed according to internationally accepted standards.~Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended).~Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose) on Day 1 of the treatment period;" (NCT03086460)
Timeframe: Baseline, Day 1, Day 14 post-dose

Heart Rate (HR) AUC(0-4h) and Peak(0-4h), Normalized by Time -- Change From Pre-dose to Post Dose Day 14

"Heart rate (HR) AUC(0-4h) and HR peak(0-4h), normalized by time (in bpm).~Results are shown as change from pre-dose on Day 14 (in bpm).~For patients receiving the same treatment in 2 periods, the average of the 2 available data points was considered in the calculation.~Definitions:~HR=Heart rate; HR AUC(0-4h)=Area under the curve between 0 and 4 h for heart rate; HR peak(0-4h)=The maximum observed value over 4 h after dosing;" (NCT03086460)
Timeframe: Baseline, Day 14 post-dose

Heart Rate (HR) AUC(0-4h), Normalized by Time -- Change From Baseline Post-dose to Post Dose Day 1 and Day 14

"Heart rate HR AUC(0-4h) normalized by time. Results are shown by treatment group, as change from baseline (in bpm).~The HR AUC(0-4h) normalized by time is calculated based on the actual times, using the linear trapezoidal rule.~For patients receiving the same treatment in 2 periods, the average of the 2 available data points was considered in the calculation.~For safety variables, the baseline for each period was defined as pre-dose measurements on Day 1 of each treatment period." (NCT03086460)
Timeframe: Baseline, Day 1, Day 14 post-dose

Heart Rate (HR) Peak(0-4h), Normalized by Time -- Change From Baseline Post-dose to Post Dose Day 1 and Day 14

"Heart rate (HR) peak(0-4h) normalized by time.~Results are shown by treatment group, as change from baseline (in bpm).~For patients receiving the same treatment in 2 periods, the average of the 2 available data points was considered in the calculation.~For safety variables, the baseline for each period was defined as pre-dose measurements on Day 1 of each treatment period.~Definitions:~HR=Heart rate; HR peak(0-4h)=The maximum observed value over 4 hours following dosing;" (NCT03086460)
Timeframe: Baseline, Day 1, Day 14 post-dose

Serum Glucose -- Change From Baseline to Post-dose Day 1 and Day 14

"Serum glucose level was monitored during the study. Results are shown by treatment group, as change from baseline (in mmol/L).~For patients receiving the same treatment in 2 periods, the average of the 2 available data points was considered in the calculation.~For safety variables, the baseline for each period was defined as pre-dose measurements on Day 1 of each treatment period." (NCT03086460)
Timeframe: Baseline, Day 1, Day 14 post-dose

Serum Potassium -- Change From Baseline Post-dose to Post Dose Day 1 and Day 14

"Serum potassium level was monitored during the study. Results are shown by treatment group, as change from baseline (in mmol/L).~For patients receiving the same treatment in 2 periods, the average of the 2 available data points was considered in the calculation.~For safety variables, the baseline for each period was defined as pre-dose measurements on Day 1 of each treatment period." (NCT03086460)
Timeframe: Baseline, Day 1, Day 14 post-dose

Vital Signs (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) -- Change From Baseline for Post-dose on Day 1 and on Day 14

"Vital signs -- Systolic blood pressure (SBP) and Diastolic blood pressure (DBP) were measured at pre-specified times (at baseline - pre dose and on Day 14 of each treatment period or on the day of early study termination).~Results are shown by treatment group, as change from baseline (in mmHg).~For patients receiving the same treatment in 2 periods, the average of the 2 available data points was considered in the calculation.~Definitions:~For safety variables, the baseline for each treatment period was defined as pre-dose measurements on Day 1 of each treatment period; Day 14=The day of the last dosing of a treatment period. Day 14 of the second, third, and fourth treatment periods (day of last dosing); treatments were separated by a 2-week wash-out interval;" (NCT03086460)
Timeframe: Baseline, Day 1 and Day 14 post-dose

Trials

1 trial available for albuterol and Fractures, Bone

Other Studies

2 other studies available for albuterol and Fractures, Bone