MedTrace Logo

Efficacy and Safety of Aclidinium Bromide at Two Dose Levels Versus Placebo Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients

NCT01001494 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 828

Last updated 2017-01-04

Study results available
· View outcomes & findings →

Summary

The main purpose of this study is to assess the long term bronchodilator efficacy, safety and tolerability of inhaled aclidinium bromide at two dose levels compared to placebo in COPD patients and the benefits of the product in disease-related health status, COPD symptoms and COPD exacerbations.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

Aclidinium bromide 200 μg bid

Aclidinium bromide 200 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks

DRUG

Aclidinium bromide 400 μg bid

Aclidinium bromide 400 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks

DRUG

Placebo

Placebo twice-daily by inhalation for 24 weeks

Sponsors & Collaborators

Principal Investigators

  • Esther Garcia, MD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Peru
  • Poland
  • Russia
  • South Africa
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
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 NCT01001494 on ClinicalTrials.gov