A study to find out the beneficial effect of blowing air through a tube immersed in bottle containing water in clearing respiratory secretions and improving quality of life in patients suffering from stable chronic obstructive pulmonary disease
Phase 3
- Conditions
- Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
- Registration Number
- CTRI/2021/10/037265
- Lead Sponsor
- SHAKTI KUMAR BA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Age 35 years or more
2. COPD patient belonging to group B, C and D
3. Not having any acute exacerbation in the last 4 weeks
Exclusion Criteria
1.Patients having acute exacerbations of COPD or hospitalisation within last 4 weeks
2.Predominant asthma or bronchiectasis on clinical assessment
3.Exercise limitation due to predominant cardiovascular disease or neuromuscular disease or cancer
4.Patient unable to use device
5.Inability to use inhaled bronchodilator therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method a)To compare the self-reported symptom severity using breathlessness cough sputum score (BCSS) in patients using PEP bottle device compared to usual care group <br/ ><br>b)Health related quality of life score using COPD assessment test score in the study group <br/ ><br>Timepoint: Outcome will be assessed at 3 months follow up <br/ ><br>
- Secondary Outcome Measures
Name Time Method a)Spirometry after 12 weeks of therapy. <br/ ><br>b)Exercise tolerance with 6-minute walk distance. <br/ ><br>c)Dyspnea status assessment using mMRC scale <br/ ><br>d)Change in sputum volume, sputum density and purulence using visual analogue scale <br/ ><br>e)Number of respiratory-related unscheduled visits to the hospital <br/ ><br>f)Number of exacerbations of COPD <br/ ><br>Timepoint: After 3 months