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

NCT03846570 | Terminated Phase 3 DMC

• 1 other identifier: NL61630.078.18
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 3

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)

Conditions

Bronchiectasis

Keywords

Randomized Controlled Trial; Inhaled corticosteroids; Placebo; Cough

Outcome Measures

Primary Outcomes (1)

• 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.)

  3 months

Secondary Outcomes (7)

• Quality of life in patient with bronchiectasis

  3 months

• Pulmonary function

  3 months

• Exacerbation frequency

  3 months

• Sputum production

  3 months

• Dyspnea score

  3 months

Other Outcomes (5)

• Inflammatory response in serum: C-reactive protein

  3 months

• Inflammatory response in serum: erythrocyte sedimentation rate

  3 months

• Inflammatory response in serum: WBC

  3 months

Study Arms (2)

Formoterol-beclomethasone

ACTIVE COMPARATOR

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

Drug: Formoterol-beclomethasone

Placebo

PLACEBO COMPARATOR

Matching placebo (identically package) administered BID

Drug: Placebo

Interventions

Formoterol-beclomethasone DRUG

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

Formoterol-beclomethasone

Placebo DRUG

Matching placebo (identically package) administered BID

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Chiesi Farmaceutici S.p.A.: collaborator

Study Sites (3)

Tjeerd van der Veer

Rotterdam, 3015GD, Netherlands

Location

Franciscus Gasthuis & Vlietland

Rotterdam, Netherlands

Location

HagaZiekenhuis

The Hague, Netherlands

Location

MeSH Terms

Conditions

Bronchiectasis; Cough

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Menno M Van der Eerden

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

• Tjeerd Van der Veer

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pulmonary physician, MD, PhD

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: February 19, 2019
• Study Start: January 29, 2019
• Primary Completion: July 5, 2022
• Study Completion: July 5, 2022
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 36 months after publication
• Access Criteria: Data can be requested immediately following publication up to 36 months, after which the data will be filed in the Erasmus MC respiratory medicine department archives without further research support. Data requests are to be addressed to: research.longziekten@erasmusmc.nl

Locations

NL (3)