NCT03900195

Brief Summary

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

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
50

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

January 21, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 2, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

April 2, 2019

Status Verified

March 1, 2019

Enrollment Period

12 months

First QC Date

January 20, 2019

Last Update Submit

March 30, 2019

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

  • Forced expiratory volume in the first minute

    Pulmonary function tests that are done with a spirometry to measure forced expiratory volume

    6 months after intervention

Secondary Outcomes (2)

  • 6 minute walking test

    6 months after intervention

  • St. George's Quality of Life Score

    6 months after intervention

Study Arms (2)

Bottle PEP

EXPERIMENTAL

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

Control

NO INTERVENTION

No interventions will be applied.

Interventions

BottlePEPOTHER

Positive expiratory device with a bottle

Bottle PEP

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with COPD
  • Stable Disease

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University School of Medicine Department of Physical Medicine and Rehabilitation

Istanbul, 34899, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ozge Kenis Coskun, Asisstant Prof.

CONTACT

+905058294947ozgekenis@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2019

First Posted

April 2, 2019

Study Start

January 21, 2019

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

April 2, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)