NCT04961008

Brief Summary

The study aims to investigate the sustainability of Bottle-PEP in patients with cystic fibrosis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 14, 2021

Completed
Last Updated

July 14, 2021

Status Verified

July 1, 2021

Enrollment Period

1.6 years

First QC Date

July 9, 2021

Last Update Submit

July 9, 2021

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

  • 6 minute walk test

    distance of meters walked in 6 minutes

    every 3 months

Study Arms (2)

Bottle-PEP

EXPERIMENTAL

Bottle-PEP

Other: Bottle-PEP

Routine physiotherapy

ACTIVE COMPARATOR

v

Other: Routine physiotherapy

Interventions

Bottle-PEPOTHER

A device that gives positive pressure from a bottle with the help of a non deflating tube

Bottle-PEP
Routine physiotherapyOTHER

Routine pulmonary physiotherapy

Routine physiotherapy

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosis of cystic fibrosis
  • Acute exacerbation

You may not qualify if:

  • Any contraindication using the Bottle - PEP such as the presence of pneumothorax

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)

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Design

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

Study Record Dates

First Submitted

July 9, 2021

First Posted

July 14, 2021

Study Start

April 1, 2019

Primary Completion

October 31, 2020

Study Completion

October 31, 2020

Last Updated

July 14, 2021

Record last verified: 2021-07

Locations

TU(1)