Clinical trial
Formoterol-beclomethasone in Patients With Bronchiectasis: a Randomized Controlled Trial
Name
NL61630.078.18
Description
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-CF) bronchiectasis, native to inhaled corticosteroid (ICS) therapy and no history of asthma or chronic obstructive pulmonary disease (COPD)
Trial arms
Trial start
2019-01-29
Estimated PCD
2022-07-05
Trial end
2022-07-05
Status
Terminated
Phase
Early phase I
Treatment
Formoterol-beclomethasone
formoterol (fumarate dihydrate) 12 microg - beclomethasone (dipropionate) 200 microg administered BID, per inhalation using '100/6' Metered Dose Inhaler
Arms:
Formoterol-beclomethasone
Placebo
Matching placebo (identically package) administered BID
Arms:
Placebo
Size
34
Primary endpoint
Clinical effect on coughing
3 months
Eligibility criteria
Inclusion Criteria:
* 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 Criteria:
* 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 34, 'type': 'ACTUAL'}}
Updated at
2023-03-01
1 organization
Organization
Erasmus Medical Center