Inhalation of corticosteroids and bronchodilators in patients with airways which are characterized by chronic inflammation: a randomized, double-blind, placebo-controlled trial (Forza study)

Phase 1

Active, not recruiting

• Conditions: Bronchiectasis; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2017-001665-25-NL
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-06
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

·Age = 18 years;
·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% and <90% (post-bronchodilator);
·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 if used 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32

Exclusion Criteria

-Possible asthma according to the definition of the Global Initiative for Asthma (GINA) with:
oPositive bronchodilator reversibility test (increase in FEV1 of >12% and >200 mL from baseline, 10–15 minutes after 200–400 mcg salbutamol or equivalent)OR
o Positive bronchial challenge test (fall in FEV1from baseline of =20% with standard doses of methacholine or histamine)
-Known intolerance for ICS or LABA.
-Other cardiopulmonary conditions (other than bronchiectasis) that could modify spirometric valeus.
-Women who are pregnant, lactating, or in whom pregnancy cannot be excluded;
-Cigarette smoking history of > 10 pack-years and/or current smokers;
-Expected to die within 72 hours after enrolment.
- Current ICS use

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Does Formoterol-beclomethasone inhalation in patients with bronchiectasis results in reduction of coughing ;Secondary Objective: Improvement of quality of life<br>reduction in exacerbations<br>24 hour sputum production (in mL);<br>dyspnea score using Mahler Scale (basal dyspnea index and transition dyspnea index;<br>safety and tolerability of long term formoterol-beclomethasone. <br>local and systemic inflammation<br>;Primary end point(s): Leicester cough questionnaire;Timepoint(s) of evaluation of this end point: 3 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): ·To evaluate the improvement of quality of life by Quality of Life Bronchiectasis (QOL-B) questionnaire’s respiratory symptom domain <br>·To evaluate the efficacy of formoterol-beclomethasone on symptoms and pulmonary function (FEV1) and the frequency of exacerbation <br> requiring an intervention with systemic antibiotics (oral/intravenous [i.v.]) in subjects with Bronchiectasis (BE). For this endpoint <br> exacerbation events are defined as events with systemic antibiotic use and worsening of at least one sign/symptom;<br>·To assess the 24 hour sputum production (in mL);<br>·To assess the dyspnea score using the mMRC (Modified Medical Research Council)<br>·To assess the safety and tolerability of long term formoterol-beclomethasone.<br>. To asses local and systemic inflammation;Timepoint(s) of evaluation of this end point: 3 months