Formoterol-beclomethasone in Patients With Bronchiectasis: a Randomized Controlled Trial (FORZA)
|ClinicalTrials.gov Identifier: NCT03846570|
Recruitment Status : Recruiting
First Posted : February 19, 2019
Last Update Posted : February 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Bronchiectasis||Drug: Formoterol-beclomethasone Drug: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Formoterol-beclomethasone in Patients With Bronchiectasis: a Randomized Controlled Trial|
|Actual Study Start Date :||January 29, 2019|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Active Comparator: Formoterol-beclomethasone
Formoterol (fumarate dehydrate) 12 microg - beclomethasone (dipropionate) 200 microg administered BID, per inhalation using '100/6' Metered Dose Inhaler.
formoterol (fumarate dihydrate) 12 microg - beclomethasone (dipropionate) 200 microg administered BID, per inhalation using '100/6' Metered Dose Inhaler
Placebo Comparator: Placebo
Matching placebo (identically package) administered BID
Matching placebo (identically package) administered BID
- Clinical effect on coughing [ Time Frame: 3 months ]Using the Leicester Cough Questionnaire (LCQ) at baseline and 3 months. The LCQ is a valid, repeatable 19 item self-completed quality of life measure of chronic cough which is responsive to change. Score range: 19-133 (Higher values represent a better outcome.)
- Quality of life in patient with bronchiectasis [ Time Frame: 3 months ]
Mean Change From Baseline in Patient Reported Outcome Quality of Life Questionnaire for Bronchiectasis (QoL-B) Respiratory Symptoms Domain Score (measured at baseline and 3 months).
The QoL-B was a disease-specific questionnaire developed for non-Cystic fibrosis Bronchiectasis. It covers 8 dimensions: physical functioning, role functioning, emotional functioning, social functioning, vitality, treatment burden, health perceptions, and respiratory symptoms. Each dimension was scored separately on a scale of 0 to 100, and higher scores represent better outcomes. For this outcome measure, the respiratory symptoms domain score was reported.
- Pulmonary function [ Time Frame: 3 months ]Spirometry: FEV1
- Exacerbation frequency [ Time Frame: 3 months ]The frequency of exacerbation requiring an intervention with systemic antibiotics (oral/intravenous [i.v.])
- Sputum production [ Time Frame: 3 months ]in mL
- Dyspnea score [ Time Frame: 3 months ]
mMRC (Modified Medical Research Council) Dyspnea Scale. This stratifies severity of dyspnea in respiratory diseases.
Grading from 0 to 4, respectively from 'no dyspnea' to 'very severe dyspnea'.
- Incidence of Adverse Events [Safety and Tolerability]). [ Time Frame: 3 months ]Incidence of Adverse Events [Safety and Tolerability]).
- Sputum culture [ Time Frame: 3 months ]Micro organisms isolated during study
- Inflammatory response in serum: C-reactive protein [ Time Frame: 3 months ]Measuring high-sensitivity C-reactive protein (mg/L) at baseline and 3 months
- Inflammatory response in serum: erythrocyte sedimentation rate [ Time Frame: 3 months ]Measuring the erythrocyte sedimentation rate (mm/h) at baseline and 3 months
- Inflammatory response in serum: WBC [ Time Frame: 3 months ]Measuring the white blood cell (WBC) count including polymorphonuclear leukocytes (10^9/L), neutrophils (10^9/L) and eosinophils (10^9/L) at baseline and 3 months
- Inflammatory response in serum: pulmonary type 2 innate lymphoid cells [ Time Frame: 3 months ]Measuring pulmonary type 2 innate lymphoid cells including IL-4, IL-5 and IL-13 (all in pg/ml) at baseline and 3 months
- Inflammatory response in sputum [ Time Frame: 3 months ]Measuring the numbers of pulmonary type 2 innate lymphoid cells (ILC2) per ml sputum, observing any change from baseline to 3 months.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03846570
|Contact: Margot JM de Koning Gans||+31107030323||J.firstname.lastname@example.org|
|Contact: Menno M Van der Eerdenemail@example.com|
|Contact: Margot JM de Koning Gans +31107030323 J.firstname.lastname@example.org|
|Principal Investigator:||Menno M Van der Eerden||Erasmus Medical Center|