A cross-section, observational, drug utilization study to assess productive cough symptom control in Br. asthma and phenotypes (ASTHMA*Cough study)
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Cough Severity at day 7
研究概览
简要总结
Cough is a protective reflex which help to remove any foreignmaterial and excessive mucous produced during the inflammation of therespiratory lining. However, cough impairs the quality of life in terms ofdisturbances in sleep, daily activities and social stigmata. Cough reflex iscomplex, which involves central and peripheral nervous system as well as thesmooth muscles of the bronchial tree. This results in bronchoconstriction,which in turn increase the sensitivity of the cough receptors. Thesupplementary role of Bronchodilatory Cough formulation in offering effectivecontrol of associated symptoms has been well highlighted. These bronchodilatorshave been suggested to offer ancillary actions that go beyond bronchodilationincluding differential impact on cough sensitivity, clearance of coughsecretions while reducing protrusive inflammatory mediators’ release that is socommon in these inflammatory conditions. At the same time these hypermucosecretory states are better controlled by a combination ofmucolytics/expectorants with bronchodilators. The complimentary action of themucolytics with bronchodilator including Terbutaline improves sputum viscosityand mucociliary clearance or expulsion for better control of productive coughsymptoms.
Data regardinguse of oral bronchodilator based cough formulations (BCF) and/or xanthines inmanagement of Bronchial asthma symptoms including cough remains unexplored.
To furtherassess the real world utilization of treatment strategies for Cough clearancein Bronchial asthma cases an observational, drug utilization, case control,concurrent analyses is planned.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Adults with bronchospastic respiratory conditions or bronchial asthma requiring outpatient therapy with bronchodilatory or mucolytic cough formulations.
排除标准
- •Patients with < 1 follow up visit to be excluded from this concurrent analyses Patients with hospitalization in the last four weeks for Uncontrolled asthma or requiring inhaled SABA of ≥6 dosages in a day for the last week Patients who have been hospitalized and received antimicrobial therapy within the last 24 hours Patients at high risk for infection with 6Ps; pneumonia, pulmonary embolism, pneumothorax, pleural effusion, pulmonary oedema [heart failure] and paroxysmal atrial tachycardia(arrhythmias).
结局指标
主要结局
Cough Severity at day 7
时间窗: Day 7
Sputum consistency at day 7
时间窗: Day 7
Nocturnal awakening frequency (No. of Episodes/night) at day 7
时间窗: Day 7
次要结局
- Treatment emergent adverse event rate with Bronchodilator based Cough Formulation and ambroxol(Day 7)
