- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01929356
Chest Physiotherapy and Lung Function in Primary Ciliary Dyskinesia
The Influence of Chest Physiotherapy on Lung Function Parameters in Primary Ciliary Dyskinesia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Primary ciliary dyskinesia (PCD) is a rare disease, caused by congenital dysfunction of the motile cilia, located in the upper and lower respiratory tract, in the reproductive system and in the embryonal node. Ineffective ciliary beating results in disturbed mucociliary clearance, which is an important defense mechanism in the respiratory tract. It causes recurrent and chronic upper and lower respiratory tract infections, leading to reversible (mucus plugging) and irreversible lung damage (bronchiectasis, atelectasis, mucus plugging). Just like cystic fibrosis, it is characterized by obstructive lung disease, measured by spirometry.
Using Multiple Breath Washout measurements, it has been shown that peripheral airways disease is present in PCD. Probably, MBW parameters are already abnormal before forced expiratory volume in one second is abnormal.
The therapy for patients with PCD is mainly supportive: regular oral or intravenous antibiotics to treat airway infections and chest physiotherapy to actively increase mucociliary clearance. Chest physiotherapy has the objective to clear mucus from the lungs. Guidelines support the treatment of patients with PCD with chest physiotherapy. It is known that in patients with PCD, exercise has a more bronchodilating effect than the administration of salbutamol. However, no objective data describe the acute effect of chest physiotherapy on spirometry and MBW parameters. Moreover, short term effects of intervention on spirometry and MBW parameters can influence the interpretation of long-term evolution of these parameters.
In cystic fibrosis, one study has assessed the short-term influence of chest physiotherapy on lung function, measured by spirometry and MBW before and after chest physiotherapy. The authors found no significant influence of chest physiotherapy on spirometry parameters, nor on MBW parameters. Therefore, longitudinal interpretation can be performed irrespective of the timing of the lung function measurements. However, cystic fibrosis and PCD have a different pathophysiological mechanism with a more 'mechanical' disturbance of the mucociliary clearance in PCD, compared to a more 'viscous' disturbance of mucociliary clearance in CF. Therefore, the results in CF are not applicable to PCD. Even more, we hypothesize that chest physiotherapy will have a significant effect on lung function parameters (spirometry and MBW) in patients with PCD due to its external mechanical effect on mucus clearance.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mieke Boon, MD
- Phone Number: +3216342589
- Email: mieke.boon@uzleuven.be
Study Locations
-
-
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Leuven, Belgium, 3000
- Recruiting
- University Hospital Gasthuisberg Leuven
-
Contact:
- Mieke Boon, MD
- Phone Number: +3216342589
- Email: mieke.boon@uzleuven.be
-
Contact:
- Christiane De Boeck, MD, Phd
- Phone Number: +3216343820
- Email: christiane.deboeck@uzleuven.Be
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Principal Investigator:
- Mieke Boon, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Primary ciliary dyskinesia
- able to perform spirometry and MBW (>6 years)
Exclusion Criteria:
- acute exacerbation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: chest physiotherapy
session of 20 minutes chest physiotherapy with physiotherapist, use of airway clearance techniques, PEP (positive expiratory pressure) device
|
20 minutes of chest physiotherapy by physiotherapist
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in FEV1 before and after treatment
Time Frame: 30 minutes
|
Lung function will be performed before a session of chest physiotherapy, and repeated 30 minutes after a chest physiotherapy session of 20 minutes with airway clearance techniques and use of PEP mask
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in LCI before and after chest physiotherapy
Time Frame: 30 minutes
|
Multiple Breath Washout (MBW) will be performed before and 30 min after a session of chest physiotherapy.
The difference in LCI (lung clearance index) will be used as secondary outcome.
|
30 minutes
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mieke Boon, MD, Research Fellow
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UZLMB001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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