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

  • STATUS
    Recruiting
  • End date
    Jun 10, 2023
  • participants needed
    72
  • sponsor
    Erasmus Medical Center
Updated on 10 April 2022
COPD
pulmonary disease
cough
cystic fibrosis
asthma
fibrosis
beclomethasone
macrolides
high resolution computed tomography

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)

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 (with or without bronchodilator), such as improvement of the HRQL, a reduction in daily sputum volume and/or exacerbation frequency. However, in all previous studies there was no clear exclusion of patients with asthma or COPD, or no use of placebo. The current study will be the first study evaluating the effect of ICS/LABA treatment in non-CF bronchiectasis excluding patients with asthma and COPD.

This is a prospective double-blind randomized controlled trial comparing Formoterol-beclomethasone 12/200 mcg BID versus placebo to evaluate the reduction in cough measured by the Leicester cough questionnaire. Secondary objectives are the improvement of health-related quality of life and symptoms, reduction in sputum production, pulmonary function (FEV1) and the frequency of exacerbation. Furthemore, we will assess the inflammatory response in serum and sputum.

After a wash-out period of 1 month, eligible subjects will be randomized to treatment with formoterol-beclomethasone or matching placebo. All subjects will be treated with the regimen of medication for 3 months. An end-of-study (EOS) visit will be performed after completion of the follow-up period.

Details
Condition Bronchiectasis
Treatment Placebo, Formoterol-beclomethasone
Clinical Study IdentifierNCT03846570
SponsorErasmus Medical Center
Last Modified on10 April 2022

Eligibility

Yes No Not Sure

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
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