Clinical trial NCT03846570: Formoterol-beclomethasone in Patients With Bronchiectasis: a Randomized Controlled Trial
Official title: Formoterol-beclomethasone in Patients With Bronchiectasis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Bronchiectasis
Keywords: Randomized Controlled Trial
Inhaled corticosteroids
Placebo
Cough
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Chiesi Farmaceutici S.p.A.
First posted: 2019-02-19
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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-CF) bronchiectasis, native to inhaled corticosteroid (ICS) therapy and no history of asthma or chronic obstructive pulmonary disease (COPD)

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 (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.

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.

Primary outcomes:
measure: Clinical effect on coughing
timeFrame: 3 months
Secondary outcomes:
measure: Quality of life in patient with bronchiectasis
timeFrame: 3 months
measure: Pulmonary function
timeFrame: 3 months
measure: Exacerbation frequency
timeFrame: 3 months
measure: Sputum production
timeFrame: 3 months
measure: Dyspnea score
timeFrame: 3 months
measure: Incidence of Adverse Events [Safety and Tolerability]).
timeFrame: 3 months
measure: Sputum culture
timeFrame: 3 months
Other outcomes:
measure: Inflammatory response in serum: C-reactive protein
timeFrame: 3 months
measure: Inflammatory response in serum: erythrocyte sedimentation rate
timeFrame: 3 months
measure: Inflammatory response in serum: WBC
timeFrame: 3 months
measure: Inflammatory response in serum: pulmonary type 2 innate lymphoid cells
timeFrame: 3 months
measure: Inflammatory response in sputum
timeFrame: 3 months
Locations:
city: Den Haag
country: Netherlands
facility: HagaZiekenhuis
city: Rotterdam
country: Netherlands
facility: Tjeerd van der Veer
city: Rotterdam
country: Netherlands
facility: Franciscus Gasthuis & Vlietland
Study officials:
affiliation: Erasmus Medical Center
name: Menno M Van der Eerden
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Center
name: Tjeerd Van der Veer
role: PRINCIPAL_INVESTIGATOR
References: