NCT06820983

Brief Summary

To carry out an assessment of compliance and quality of life in a population (children and adults) with DDB before and after the use of an oscillating PEP. The aim is to determine the impact of the use of oscillating PEP on the daily life of this population in particular.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

October 17, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 11, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

1.5 years

First QC Date

February 6, 2025

Last Update Submit

January 22, 2026

Conditions

BronchiectasisQuality of LifePhysiotherapy

Keywords

quality of lifeBronchiectasisoscillating PEP devicesphysiotherapy

Outcome Measures

Primary Outcomes (1)

  • Variation of patient quality of life before and after OPEP installation

    quality of life is determined by qustionnaire

    18 months

Interventions

Quality of life questionnaire for children aged 8 to 13OTHER

Quality of life questionnaire for children aged 8 to 13

adult questionnary for parents of children aged 8 to 13OTHER

Quality of life questionnaire for parents of children aged 8 to 13

Quality of life questionnaire for adolescents aged 14 to 17OTHER

Quality of life questionnaire for adolescents aged 14 to 17

Quality of life questionnaire for adultsOTHER

Quality of life questionnaire for adults

A satisfaction adherence questionnaireOTHER

A satisfaction adherence questionnaire will also be distributed to patients after several months' use of oscillating PEP

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Children (from 8 years of age) and adults over 18 years of age with DDB who doesn't use oscillating PEP.
  • The study population will be clinically stable and will be seen in follow-up consultations.

You may not qualify if:

  • Children under 8 years of age.
  • Patients who use an OPEP
  • Patients in the acute exacerbation phase of their DDB
  • Patients who are not under regular consultation
  • Patients with severe, uncontrolled co-morbidities
  • Patients with cognitive or psychiatric disorders preventing proper adherence to the study protocol
  • Patients taking part simultaneously in another clinical study that could interfere with the results of the OPEP study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens-Picardie

Amiens, 80054, France

RECRUITING

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Central Study Contacts

Thomas PINTO, MD

CONTACT

33+3 22 08 80 00pinto.thomas@chu-amiens.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2025

First Posted

February 11, 2025

Study Start

October 17, 2024

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)