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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

Efficacy of bottle positive expiratory pressure as an adjunct therapy to bronchodilators in improving quality of life and functional status of patients with stable COPD- A Randomised control trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/10/037265
Enrollment
124
Registered
2021-10-12
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified

Interventions

Intervention1: BOTTLE POSITIVE EXPIRATORY PRESSURE THERAPY: INTERVENTION GROUP PATIENTS WILL BE ASKED TO EXHALE THROUGH A TUBE OF 10 MM INTERNAL DIAMETER IMMERSED IN A 1 LITRE BOTTLE CONTAINING WATER

Sponsors

SHAKTI KUMAR BAL
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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 b)Health related quality of life score using COPD assessment test score in the study group Timepoint: Outcome will be assessed at 3 months follow up

Secondary

MeasureTime frame
a)Spirometry after 12 weeks of therapy. b)Exercise tolerance with 6-minute walk distance. c)Dyspnea status assessment using mMRC scale d)Change in sputum volume, sputum density and purulence using visual analogue scale e)Number of respiratory-related unscheduled visits to the hospital f)Number of exacerbations of COPD Timepoint: After 3 months

Countries

India

Contacts

Public ContactShakti Kumar Bal

All India Institute of Medical Sciences Bhubaneswar

leeshakti@gmail.com9345708801

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026