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

NCT03846570 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2023-03-01

No results posted yet for this study

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

Interventions

DRUG

Formoterol-beclomethasone

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

DRUG

Placebo

Matching placebo (identically package) administered BID

Sponsors & Collaborators

Principal Investigators

  • Menno M Van der Eerden · Erasmus Medical Center

  • Tjeerd Van der Veer · Erasmus Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-29
Primary Completion
2022-07-05
Completion
2022-07-05

Countries

  • Netherlands

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03846570 on ClinicalTrials.gov