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

NCT ID: NCT03846570

Last Updated: 2023-03-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-29
• Study Completion Date: 2022-07-05

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.

Conditions

Bronchiectasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Formoterol-beclomethasone

Formoterol (fumarate dehydrate) 12 microg - beclomethasone (dipropionate) 200 microg administered BID, per inhalation using '100/6' Metered Dose Inhaler.

Group Type: ACTIVE_COMPARATOR

Formoterol-beclomethasone

Intervention Type: DRUG

formoterol (fumarate dihydrate) 12 microg - beclomethasone (dipropionate) 200 microg administered BID, per inhalation using '100/6' Metered Dose Inhaler

Placebo

Matching placebo (identically package) administered BID

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo (identically package) administered BID

Interventions

Formoterol-beclomethasone

formoterol (fumarate dihydrate) 12 microg - beclomethasone (dipropionate) 200 microg administered BID, per inhalation using '100/6' Metered Dose Inhaler

Intervention Type: DRUG

Placebo

Matching placebo (identically package) administered BID

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chiesi Farmaceutici S.p.A.

INDUSTRY

Sponsor Role: collaborator

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Menno M. van der Eerden

Pulmonary physician, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Menno M Van der Eerden

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Tjeerd Van der Veer

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

Tjeerd van der Veer

Rotterdam, , Netherlands

Franciscus Gasthuis & Vlietland

Rotterdam, , Netherlands

HagaZiekenhuis

The Hague, , Netherlands

Countries

Netherlands

Other Identifiers

NL61630.078.18

Identifier Type: -

Identifier Source: org_study_id