Formoterol-beclomethasone in Patients With Bronchiectasis: a Randomized Controlled Trial

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Erasmus Medical Center
• Collaborator: Chiesi Farmaceutici S.p.A.
• Treatments: Beclomethasone; Formoterol Fumarate

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.