Status:
UNKNOWN
Is a Single Daily Session Combining HS + Physio Sufficient to Obtain Long-term Clinical Benefits in Bronchiectasis?
Lead Sponsor:
Hospital Clínico Universitario Lozano Blesa
Collaborating Sponsors:
Hospital Clinic of Barcelona
Universidad San Jorge
Conditions:
Bronchiectasis
Airway Clearance Impairment
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The present study will aim to find out whether a home treatment in people with bronchiectasis consisting of a single daily session to facilitate expectoration (combining nebulization of hypertonic sal...
Detailed Description
A non-inferiority randomised clinical trial (single-blind) will be conducted. At least 50 participants will be recruited from the outpatient clinics of the Hospital Clinic in Barcelona and the Clinica...
Eligibility Criteria
Inclusion
- 18 years or older
- a total score less than 16 on the Leicester Cough Questionnaire
- chronic daily expectoration over at least 3 months
- being in a period of clinical stability during the previous 4 weeks
- presenting a forced expiratory volume in 1 second (FEV1) value greater than 40% of predicted or \>1 L
- obtaining informed consent.
- In addition, all participants will have had to satisfactorily pass the tolerability tests, which will be performed twice: i) on the first day; ii) and the following week.
Exclusion
- having received nebulised mucoactive treatment during the previous year
- frequent haemoptysis (≥ 2 times/month)
- diagnosis or suspicion of cystic fibrosis by genetic study or sweat test
- being under active treatment for nontuberculous mycobacteria (NTM)
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04905992
Start Date
July 1 2021
End Date
December 1 2023
Last Update
June 18 2021
Active Locations (2)
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1
Hospital Clinic
Barcelona, Spain
2
Beatriz Herrero Cortina
Zaragoza, Spain