A Phase 3 interventional study of Formoterol-beclomethasone and Placebo in Bronchiectasis, sponsored by Erasmus Medical Center. Terminated at 3 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-01.
Sponsored by Erasmus Medical Center · Phase 3, Interventional, and Treatment
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)
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.
368 studies on the registry are indexed under Bronchiectasis; 104 are open to participants now.
This study's enrollment of 34 is below the median of 60 across 233 interventional studies indexed under Bronchiectasis.
Browse Bronchiectasis studies →Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.
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Exclusion Criteria:
Formoterol (fumarate dehydrate) 12 microg - beclomethasone (dipropionate) 200 microg administered BID, per inhalation using '100/6' Metered Dose Inhaler.
Drug: Formoterol-beclomethasone
Matching placebo (identically package) administered BID
Drug: Placebo
formoterol (fumarate dihydrate) 12 microg - beclomethasone (dipropionate) 200 microg administered BID, per inhalation using '100/6' Metered Dose Inhaler
Matching placebo (identically package) administered BID
Clinical effect on coughing
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.)
Time frame: 3 months
Quality of life in patient with bronchiectasis
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.
Time frame: 3 months
Pulmonary function
Spirometry: FEV1
Time frame: 3 months
Exacerbation frequency
The frequency of exacerbation requiring an intervention with systemic antibiotics (oral/intravenous \[i.v.\])
Time frame: 3 months
Sputum production
in mL
Time frame: 3 months
Dyspnea score
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'.
Time frame: 3 months
Incidence of Adverse Events [Safety and Tolerability]).
Incidence of Adverse Events \[Safety and Tolerability\]).
Time frame: 3 months
Sputum culture
Micro organisms isolated during study
Time frame: 3 months
Inflammatory response in serum: C-reactive protein
Measuring high-sensitivity C-reactive protein (mg/L) at baseline and 3 months
Time frame: 3 months
Inflammatory response in serum: erythrocyte sedimentation rate
Measuring the erythrocyte sedimentation rate (mm/h) at baseline and 3 months
Time frame: 3 months
Inflammatory response in serum: WBC
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
Time frame: 3 months
Inflammatory response in serum: pulmonary type 2 innate lymphoid cells
Measuring pulmonary type 2 innate lymphoid cells including IL-4, IL-5 and IL-13 (all in pg/ml) at baseline and 3 months
Time frame: 3 months
Inflammatory response in sputum
Measuring the numbers of pulmonary type 2 innate lymphoid cells (ILC2) per ml sputum, observing any change from baseline to 3 months.
Time frame: 3 months
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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This study is terminated, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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