(9R)-9-chloro-11-17-dihydroxy-17-(2-hydroxy-1-oxoethyl)-10-13-16-trimethyl-6-7-8-11-12-14-15-16-octahydrocyclopenta[a]phenanthren-3-one and Respiration-Disorders

Chronic non-specific respiratory symptoms are difficult to manage. This trial aimed to evaluate the association between baseline fractional exhaled nitric oxide (FeNO) and the response to inhaled corticosteroids in patients with non-specific respiratory symptoms.. In this double-blind randomised placebo-controlled trial, we enrolled undiagnosed patients, aged 18-80 years, with cough, wheeze, or dyspnoea and less than 20% bronchodilator reversibility across 26 primary care centres and hospitals in the UK and Singapore. Patients were assessed for 2 weeks before being randomly assigned (1:1) to 4 weeks of treatment with extrafine inhaled corticosteroids (QVAR 80 μg, two puffs twice per day, equivalent to 800 μg per day beclomethasone dipropionate) or placebo. Randomisation was stratified by baseline FeNO measurement: normal (≤25 parts per billion [ppb]), intermediate (>25 tp <40 ppb), and high (≥40 ppb). The primary endpoint was change in Asthma Control Questionnaire (ACQ7) mean score. We used generalised linear modelling to assess FeNO as a predictor of response, estimating an interaction effect between FeNO and treatment on change in ACQ7. We did our primary and secondary analyses in the per-protocol set, which excluded patients with non-completion of the primary endpoint, non-compliance to treatment (ascertained by patient report), and study visits made outside the predefined visit windows. This study is registered on ClinicalTrials.gov, number NCT02294279.. Between Feb 4, 2015, and July 12, 2016, we randomly assigned 294 patients to extrafine inhaled corticosteroid treatment (n=148) or placebo (n=146). Following exclusions due to protocol violations, we analysed 214 patients (114 extrafine inhaled corticosteroids and 100 placebo). We observed a significant interaction between baseline FeNO and treatment group for every 10 ppb increase in baseline FeNO, with the change in ACQ7 greater in the extrafine inhaled corticosteroids group than in the placebo group (difference between groups 0·071, 95% CI 0·002 to 0·139; p=0·044). The most common adverse events were nasopharyngitis (18 [12%] patients in the treatment group vs 13 [9%] in the placebo group), infections and infestations (25 [17%] vs 21 [14%]), and respiratory, thoracic, and mediastinal disorders (13 [9%] vs 17 [12%]).. FeNO measurement is an easy and non-invasive tool to use in clinical practice in patients with non-specific respiratory symptoms to predict response to inhaled corticosteroids. Further research is needed to examine its role in patients with evidence of other airway diseases, such as chronic obstructive pulmonary disease.. Sponsored by OPRI with partial funding by Circassia and study drugs provided by TEVA.

Topics: Administration, Inhalation; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Asthmatic Agents; Beclomethasone; Double-Blind Method; Exhalation; Female; Humans; Male; Middle Aged; Nitric Oxide; Respiration Disorders; Treatment Outcome; Young Adult

Preterm infants often suffer from recurrent respiratory symptoms at follow up. Although these infants are responsive to treatment with bronchodilators some continue to wheeze or cough despite treatment. In a randomised double blind placebo controlled trial, the ability of inhaled steroids to reduce recurrent respiratory symptoms and the requirement for bronchodilator treatment in preterm infants less than two years of age has been assessed.. Eighteen premature infants with mean gestational age 28 weeks and postnatal age 10.5 months were recruited. The study consisted of two six week treatment periods separated by a two week washout period. The infants received either 200 micrograms of beclomethasone dipropionate or placebo as one puff twice daily from an inhaler, through a spacer and a face mask. Parents kept a daily record of their infants' respiratory tract symptoms (wheeze and cough) and use of bronchodilators. Functional residual capacity (FRC) was measured at the beginning and end of each six week period.. The symptom score was reduced by 37% in the active compared with the placebo period. During the active period the infants had a mean of 28 bronchodilator free days, compared with 22 days in the placebo period. The FRC improved significantly in the active but not the placebo period.. Regular dosage with beclomethasone by inhalation is a useful treatment for preterm infants with respiratory symptoms.

Topics: Administration, Inhalation; Beclomethasone; Double-Blind Method; Functional Residual Capacity; Humans; Infant, Newborn; Infant, Premature, Diseases; Lung; Respiration Disorders

Chronic respiratory diseases (CRDs) affect hundreds of millions of people. The United Nations 2011 meeting on non-communicable diseases (NCDs) marked a turning point in addressing this burden. The targets established following this meeting incorporated specific measures to address the availability and affordability of essential medicines. These are aligned with the sustainable development goals (SDGs) and the push for universal health coverage. However, essential medicines for CRDs remain unaffordable and unavailable to many. For asthma, the availability of medicines was respectively 30.1% and 43.1% in the public and private sectors. The maximum annual costs of treatment were US$102.10 for beclometasone, US$82.99 for salbutamol and US$1501.79 for budesonide, representing respectively 40%, 15% and 209% of per capita income in Malawi, Burkina Faso and Guinea. Multiple factors contribute to poor availability and affordability. Experience from human immunodeficiency virus/acquired immune-deficiency syndrome shows that medicines and care can be delivered in low-income countries and among the NCDs. A unique example of an effective mechanism for providing access to affordable essential CRD medicines is the Asthma Drug Facility. Working on the six health system building blocks proposed by the World Health Organization can help countries address not only problems regarding access to medicines, but also those hampering adequate care. Improving medicine supply systems, training, national guidelines, financing, research, data utilisation and models of care at the primary health care level will help. A CRD target (e.g., 50% reduction in asthma hospitalisations) as well as the use of asthma as a measure for health system effectiveness and CRDs as a tracer for SDGs would help focus global, national and local leadership.

Topics: Albuterol; Anti-Asthmatic Agents; Beclomethasone; Burkina Faso; Chronic Disease; Developing Countries; Drugs, Essential; Guidelines as Topic; Guinea; Health Services Accessibility; Humans; Malawi; Noncommunicable Diseases; Private Sector; Public Sector; Respiration Disorders; United Nations; World Health Organization

Topics: Administration, Inhalation; Adrenal Cortex Hormones; Allergy and Immunology; Beclomethasone; Drug Labeling; Humans; Hypersensitivity; Respiration Disorders; Societies, Medical; United States; United States Food and Drug Administration; Virus Diseases

Topics: Adult; Beclomethasone; Female; Humans; Nasal Decongestants; Respiration Disorders; Respiratory Sounds