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Clinical Trials/NCT06393257
NCT06393257
Recruiting
Not Applicable

Efficacy and Safety of Airway Clearance Technique by Oscillation and Lung Expansion in Patients With Bronchiectasis

Shanghai Pulmonary Hospital, Shanghai, China3 sites in 1 country96 target enrollmentSeptember 1, 2023

Overview

Phase
Not Applicable
Intervention
Oscillation and Lung Expansion
Conditions
Bronchiectasis Adult
Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Enrollment
96
Locations
3
Primary Endpoint
sputum volume in 24h
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The goal of this prospective randomized controlled trial is to explore the efficacy and safety of Oscillation and Lung Expansion-a airway clearance technology-in bronchiectasis. Participants will receive Oscillation and Lung Expansion or postural drainage randomly in this study. and the symptom, quality of life scores and amount of expectoration will be compared between the two groups.

Registry
clinicaltrials.gov
Start Date
September 1, 2023
End Date
May 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Responsible Party
Principal Investigator
Principal Investigator

Jin-Fu Xu

Professor

Shanghai Pulmonary Hospital, Shanghai, China

Eligibility Criteria

Inclusion Criteria

  • patients with acute exacerbation of bronchiectasis

Exclusion Criteria

  • Haemoptysis greater than 50ml
  • state of endangerment
  • pneumothorax
  • Lung surgery history within 6 months
  • Severe heart, brain and nervous system diseases

Arms & Interventions

Oscillation and Lung Expansion

Intervention: Oscillation and Lung Expansion

Oscillation and Lung Expansion

Intervention: Anti-infective therapy

Oscillation and Lung Expansion

Intervention: Mucolytic

postural drainage

Intervention: Postural drainage

postural drainage

Intervention: Anti-infective therapy

postural drainage

Intervention: Mucolytic

Outcomes

Primary Outcomes

sputum volume in 24h

Time Frame: 2 weeks

Secondary Outcomes

  • Bronchiectasis exacerbation and symptom tool(Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge)
  • Quality of life questionnaire-bronchiectasis(Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge)
  • Leicester Cough Questionnaire(Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge)
  • Bronchiectasis Health Questionnaire(Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge)
  • Time to the first bronchiectasis exacerbation since randomization(Assessed at 4 weeks, 8 weeks and 12 weeks post-discharge)

Study Sites (3)

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