Formoterol-beclomethasone in Patients With Bronchiectasis: a Randomized Controlled Trial
NCT03846570 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2023-03-01
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-CF) bronchiectasis, native to inhaled corticosteroid (ICS) therapy and no history of asthma or chronic obstructive pulmonary disease (COPD)
Conditions
Interventions
- DRUG
-
Formoterol-beclomethasone
formoterol (fumarate dihydrate) 12 microg - beclomethasone (dipropionate) 200 microg administered BID, per inhalation using '100/6' Metered Dose Inhaler
- DRUG
-
Matching placebo (identically package) administered BID
Sponsors & Collaborators
-
Chiesi Farmaceutici S.p.A.
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Menno M Van der Eerden · Erasmus Medical Center
-
Tjeerd Van der Veer · Erasmus Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-01-29
- Primary Completion
- 2022-07-05
- Completion
- 2022-07-05
Countries
- Netherlands
Study Locations
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