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The Effectiveness of Bottle-PEP in Chronic Obstructive Pulmonary Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03900195
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Information provided by (Responsible Party):
Marmara University

Brief Summary:
The effectiveness of Bottle PEP in patients with Chronic Obstructive Pulmonary Disease

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Other: BottlePEP Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effectiveness of Bottle-PEP in Chronic Obstructive Pulmonary Disease
Actual Study Start Date : January 21, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: Bottle PEP
Bottle PEP is a positive expiratory system that is applied via a tube of more than 5 mm of thickness and a bottle filled with water about 10 cms.
Other: BottlePEP
Positive expiratory device with a bottle

No Intervention: Control
No interventions will be applied.

Primary Outcome Measures :
  1. Forced expiratory volume in the first minute [ Time Frame: 6 months after intervention ]
    Pulmonary function tests that are done with a spirometry to measure forced expiratory volume

Secondary Outcome Measures :
  1. 6 minute walking test [ Time Frame: 6 months after intervention ]
    6 minute walking test is a field test that measures the distance a patient walks during a 6 minute period.

  2. St. George's Quality of Life Score [ Time Frame: 6 months after intervention ]

    Scores are calculated for three domains:

    Symptoms, Activity and Impacts (Psycho-social) as well as a total score.

    Psychometric testing has demonstrated its repeatability, reliability and validity. Sensitivity has been demonstrated in clinical trials.

    A minimum change in score of 4 units was established as clinically relevant after patient and clinician testing. This score has been used in a range of disease groups including asthma, chronic obstructive pulmonary disease and bronchiectasis, and in a range of settings such as randomised controlled therapy trials and population surveys.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosed with COPD
  • Stable Disease

Exclusion Criteria:

  • Neuromuscular disease
  • Recent pneumothorax
  • Major surgery in the last 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03900195

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Contact: Ozge Kenis Coskun, Asisstant Prof. +905058294947

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Marmara University School of Medicine Department of Physical Medicine and Rehabilitation Recruiting
Istanbul, Turkey, 34899
Contact: Ozge Kenis-Coskun, MD    5058294947   
Contact: , MD         
Sponsors and Collaborators
Marmara University

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Responsible Party: Marmara University Identifier: NCT03900195     History of Changes
Other Study ID Numbers: 09.2019.052
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases