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Study to Assess Efficacy and Safety of Aclidinium Bromide and Aclidinium Bromide/Formoterol Fumarate in Stabile COPD Patients

NCT03022097 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1625

Last updated 2025-03-26

Study results available
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Summary

This is a multiple dose, randomised, parallel, double blind, double dummy, multicentre and multinational Phase III study to determine the efficacy and safety of Aclidinium bromide/Formoterol fumarate compared with individual components and placebo and Aclidinium bromide compared with Placebo when administered to patients with stable Chronic Obstructive Pulmonary Disease (COPD).

Conditions

Interventions

DRUG

Aclidinium bromide/formoterol Fixed-Dose Combination

Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination, twice per day via Genuair

DRUG

Aclidinium bromide

Inhaled Aclidinium bromide 400 μg, twice per day via Genuair

DRUG

Formoterol Fumarate

Inhaled Formoterol Fumarate 12 μg, twice per day via Turbuhaler

DRUG

Placebo

Inhaled dose-matched placebo, twice per day via Genuair or via Turbuhaler

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-02
Primary Completion
2022-04-14
Completion
2022-04-14

Countries

  • China
  • India
  • Philippines
  • Taiwan
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT03022097 on ClinicalTrials.gov