Status:
TERMINATED
Formoterol-beclomethasone in Patients With Bronchiectasis: a Randomized Controlled Trial
Lead Sponsor:
Erasmus Medical Center
Collaborating Sponsors:
Chiesi Farmaceutici S.p.A.
Conditions:
Bronchiectasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Randomized, double-blind, placebo-controlled study comparing formoterol-beclometason 12/200 mcg BID versus placebo to evaluate the clinical effect on coughing in patients with non-cystic fibrosis (non...
Detailed Description
In the management of non-CF bronchiectasis, bronchodilator treatment (LABA)and use of inhaled corticosteroids (ICS) is still a matter of debate. Previous studies have claimed beneficial effects of ICS...
Eligibility Criteria
Inclusion
- Symptomatic patient (wheezing, cough and dyspnoea);
- Proven and documented diagnosis of BE by high resolution computed tomography ;
- Stable pulmonary status as indicated by FEV1 (percent of predicted) ≥30%
- Stable clinically phase (ie, subjects free from acute exacerbation for at least 6 weeks prior to the start of the study);
- Stable regimen of standard treatment as chronic treatment for BE, at least for the past 4 weeks prior to screening. And/or macrolides if used as chronic treatment for BE at least for the past 6 months prior to screening;
- Coughing on the majority of days for more than 8 weeks;
- Ability to follow the inhaler device instructions;
- Ability to complete questionnaires;
- Written informed consent.
Exclusion
- Possible asthma according to the definition of the Global Initiative for Asthma (GINA);
- Positive histamine provocation test
- Known intolerance for ICS or LABA;
- Women who are pregnant, lactating, or in whom pregnancy cannot be excluded;
- Expected to die within 72 hours after enrolment;
- Cigarette smoking history of \> 10 pack-years or current smokers;
- Other cardiopulmonary conditions (other than bronchiectasis) that could modify spirometric values.
Key Trial Info
Start Date :
January 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 5 2022
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03846570
Start Date
January 29 2019
End Date
July 5 2022
Last Update
March 1 2023
Active Locations (3)
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1
Tjeerd van der Veer
Rotterdam, Netherlands, 3015GD
2
Franciscus Gasthuis & Vlietland
Rotterdam, Netherlands
3
HagaZiekenhuis
The Hague, Netherlands