MedTrace Logo

Effect of Aclidinium/Formoterol on Lung Hyperinflation, Exercise Capacity and Physical Activity in Moderate to Severe COPD Patients

NCT02424344 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 267

Last updated 2018-10-09

Study results available
· View outcomes & findings →

Summary

The present study is planned to evaluate the effect of the aclidinium bromide/formoterol fumarate 400/12 μg FDC BID on the hyperinflation, exercise endurance and physical activity in patients with moderate to severe COPD. Additionally, the effect of the behavioural intervention on top of aclidinium bromide/formoterol fumarate 400/12 μg will be assessed both on the exercise endurance and the physical activity.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Aclidinium/Formoterol

Aclidinium bromide/Formoterol fumarate FDC 400/12μg dry powder for oral inhalation twice daily via Genuair inhaler

DRUG

Placebo

Dose-matched placebo dry powder for oral inhalation twice daily via Genuair inhaler

Sponsors & Collaborators

  • Menarini Group

    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
2015-04-27
Primary Completion
2016-07-25
Completion
2016-07-25

Countries

  • Canada
  • Germany
  • Hungary
  • Spain

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 NCT02424344 on ClinicalTrials.gov