Back to resultsBottle PEP in Cystic Fibrosis
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bottle-PEP
Routine physiotherapy
Sponsored by
About this trial
This is an interventional supportive care trial for Cystic Fibrosis
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of cystic fibrosis
- Acute exacerbation
Exclusion Criteria:
- Any contraindication using the Bottle - PEP such as the presence of pneumothorax
Sites / Locations
- Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Bottle-PEP
Routine physiotherapy
Arm Description
Bottle-PEP
v
Outcomes
Primary Outcome Measures
6 minute walk test
distance of meters walked in 6 minutes
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04961008
Brief Title
Bottle PEP in Cystic Fibrosis
Official Title
Safety and Sustainability in Bottle PEP in Cystic Fibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
October 31, 2020 (Actual)
Study Completion Date
October 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study aims to investigate the sustainability of Bottle-PEP in patients with cystic fibrosis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bottle-PEP
Arm Type
Experimental
Arm Description
Bottle-PEP
Arm Title
Routine physiotherapy
Arm Type
Active Comparator
Arm Description
v
Intervention Type
Other
Intervention Name(s)
Bottle-PEP
Intervention Description
A device that gives positive pressure from a bottle with the help of a non deflating tube
Intervention Type
Other
Intervention Name(s)
Routine physiotherapy
Intervention Description
Routine pulmonary physiotherapy
Primary Outcome Measure Information:
Title
6 minute walk test
Description
distance of meters walked in 6 minutes
Time Frame
every 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of cystic fibrosis
Acute exacerbation
Exclusion Criteria:
Any contraindication using the Bottle - PEP such as the presence of pneumothorax
Facility Information:
Facility Name
Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Bottle PEP in Cystic Fibrosis
We'll reach out to this number within 24 hrs