NCT07713043

Brief Summary

COPD is a progressive lung disease that includes emphysema and chronic bronchitis and is a major cause of morbidity and mortality worldwide. Airway clearance techniques help improve mucus removal, reduce dyspnea, and enhance quality of life in COPD patients. This study aims to compare the effects of autogenic drainage and flutter device on dyspnea, pulmonary function, and functional capacity in patients with COPD. A randomized clinical trial will be conducted at Gulab Devi Teaching Hospital using convenient sampling. Participants will be divided into two groups: Group A will receive autogenic drainage, while Group B will use the flutter device. Interventions will be performed daily for 20-30 minutes over 6 weeks. Outcome measures will include dyspnea severity scale, spirometry, and 6-minute walk test. Data will be analyzed using SPSS with significance set at p \< 0.05. The study may provide evidence for effective, non-invasive, and cost-effective management strategies for COPD patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2026

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 20, 2026

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Completed
Last Updated

July 20, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

June 8, 2026

Last Update Submit

July 17, 2026

Conditions

Keywords

Autogenic drainageCOPDDyspneaFlutter deviceFunctional capacityPulmonary function test

Outcome Measures

Primary Outcomes (5)

  • Dyspnea

    The modified medical research council; (mMRC) Dyspnea Scale is a simple and widely used scale

    Baseline and after 6 weeks of intervention

  • Forced Vital Capacity

    Forced Vital Capacity (FVC) will be measured in liters (L) using spirometry. FVC represents the maximum volume of air that can be forcefully exhaled after a maximal inspiration.

    Baseline and after 6 weeks of intervention

  • Forced Expiratory Volume in One Second

    Forced Expiratory Volume in One Second (FEV₁) will be measured in liters (L) using spirometry. FEV₁ represents the volume of air exhaled during the first second of a forced expiratory maneuver.

    Baseline and after 6 weeks of intervention

  • FEV₁/FVC ratio

    The FEV₁/FVC ratio will be expressed as a percentage (%) and calculated from spirometric measurements to assess the degree of airflow limitation.

    Baseline and after 6 weeks of intervention

  • Peak Expiratory Flow

    Peak Expiratory Flow (PEF) will be measured in liters per minute (L/min) and represents the maximum expiratory flow achieved during forced expiration.

    Baseline and after 6 weeks of intervention

Study Arms (2)

Autogenic drainage

EXPERIMENTAL

The participants in this group will be instructed to sit comfortably with the neck slightly extended and clear the upper airways by huffing or blowing the nose. Autogenic drainage begins with slow diaphragmatic breathing at low lung volumes, followed by a 3-second pause and gentle high-velocity expiration with an open glottis. As secretions move upward, breathing gradually shifts to medium and high lung volumes until mucus reaches the trachea for expectoration. The cycle of breathing exercises is repeated for 15-20 minutes while suppressing unnecessary coughing.

Procedure: Autogenic drainage

Flutter Device (Positive expiratory pressure technique)

EXPERIMENTAL

The participant in this group will be instructed to sit comfortably while leaning forward with elbows supported and the neck slightly extended to open the airway. The flutter device is held horizontally with a slight upward tilt and placed in the mouth. The patient inhales slowly through the nose, holds the breath for 3-5 seconds, and exhales through the flutter device slightly faster than normal. After 4-8 breaths, a deep inhalation followed by forced expiration through the device helps mobilize secretions. Breathing control is maintained, followed by coughing or huffing if needed. The procedure is repeated for 10-15 minutes.

Device: Flutter Device

Interventions

The flutter device will hold horizontally and tilted slightly upwards to get maximal oscillatory effect and then it was placed in the mouth. Inspiration was done through the nose. A slow breath in, only slightly deeper than normal with a breath hold of 3-5 seconds will followed by breath out through the flutter device at a slightly faster rate than normal. After 4-8 breaths, a deep breath with a hold' at full inspiration will followed by a force expiration through the flutter device. This precipitated expectoration and will followed by a pause for breathing control, and then according to the subjects' preference a cough or huff was done

Flutter Device (Positive expiratory pressure technique)

The patient begins by performing the diaphragmatic breathing at low lung volume inspiration will slow with a pause of three seconds allowing the collateral ventilation, and expiration will done as a sigh with an open glottis and with high velocity as possible but no forced expiration. During this low lung volume breathing, expiration will encourage to the expiratory reserve volume. When the patient feel secretions to be moving, the volume of inspiration became deeper and expiration did not go down as far as expiratory reserve volume. As the secretions moved up the bronchial tree to the large airways then the patient will ask to perform higher lung volume breathing, tidal volume to inspiratory reserve volume range. This middle to high lung volume breathing continued until the secretions will in the trachea and ready to be expectorated

Also known as: Controlled Breathing Drainage, Airway Clearance Breathing Technique
Autogenic drainage

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age group: Middle age adults (40-60 years), medically stable
  • Both gender
  • Diagnosis based on GOLD criteria ((FEV₁/FVC ratio \< 0.70).
  • Moderate COPD with no acute exacerbations in the past 4-6 weeks.
  • Participants must be able to perform Autogenic drainage and Flutter device physically and mentally.
  • Voluntary participation with consent.

You may not qualify if:

  • Cardic Diseases (Acute MI, Congestive Heart Failure)
  • Musculoskeletal Impairements
  • Using Non-invasive Ventilation
  • Recent lung diseases (Respiratory failure, pneumothorax)
  • Hemodynamic instability
  • Uncoorperative patients
  • Cognitive Impairement scale
  • Participants excluded if they did not consent
  • Comorbidities affecting exercise tolerance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nimra Noor

Lahore, Punjab Province, 40100, Pakistan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Arjumand Bano, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Iqbal Tariq Tariq, Phd*

CONTACT

Nimra noor Noor, MS-CPPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Because of the physical nature of the interventions, both participants and investigators will know which treatment is being given. No blinding will be applied.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly added into two groups. Group A will receive autogenic drainage intervention and the Group B will receive flutter device intervention. Both interventions will be practiced daily for 5 days 6 weeks for 20-30 minutes. Outcomes will be measured at baseline and after intervention to compare treatment effects.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2026

First Posted

July 20, 2026

Study Start

June 1, 2026

Primary Completion

August 1, 2026

Study Completion

August 1, 2026

Last Updated

July 20, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations