Loading clinical trials...

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

COMPLETEDPHASE4

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

A Multiple Dose, Randomized, Double-blind, Placebo Controlled, Parallel Clinical Trial to Assess the Effect of Aclidinium Bromide/Formoterol Fumarate Fixed-dose Combination on Lung Hyperinflation, Exercise Capacity and Physical Activity in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

NCT02424344•AstraZeneca

View on ClinicalTrials.gov

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.

Eligibility

Age

40 - 130 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Males and non-pregnant, non-lactating females aged ≥ 40.
•2. Patients with a clinical diagnosis of COPD according to GOLD guidelines 2014, with a post bronchodilator FEV1 ≥ 40% and \< 80% of the predicted value and FEV1/FVC \< 70% at Visit 1.
•3. Functional residual capacity (FRC) measured by body plethysmography at Visit 1 ≥ 120% of predicted value.
•4. Patients with modified Medical Research Council dyspnea scale (mMRC) ≥ 2 at Visit 1.
•5. Current or former cigarette smokers with a smoking history of at least 10 pack-years at Visit 1
•6. Patients willing to participate in the telecoaching program during the four last weeks and to enhance their physical activity
•7. Patients who understand and are able to follow the study procedures, are cooperative and are willing to participate in the study as indicated by signing the informed consent.

Exclusion Criteria

•1. History or current diagnosis of asthma.
•2. Any respiratory tract infection (including upper respiratory tract) or COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period.
•3. Patients who have been hospitalised for an acute COPD exacerbation within 3 months prior to Visit 1 or during the run-in period.
•4. Clinically significant respiratory conditions other than COPD.
•5. Use of long-term oxygen therapy (≥ 15 hours/day).
•6. Oxygen saturation ≤ 85% as measured by pulse oximetry during exercise testing at Visit 1, Visit 2 or Visit 3 prior to randomisation.
•7. Patients with a Body Mass Index (BMI) ≥ 40kg/m2.
•8. Patient who may need to start a pulmonary rehabilitation program during the study and/or who started/finished it within 3 months prior to Visit 1 or during the run-in period.
•9. Patients with clinically significant cardiovascular conditions.
•10. Patients with Type I or uncontrolled Type II diabetes, uncontrolled hypo-or hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled or untreated hypertension.
+13 more criteria

Locations (26)

Research Site

Hamilton, Ontario, Canada

Research Site

Kingston, Ontario, Canada

Research Site

Sainte-Foy, Quebec, Canada

Research Site

Saskatoon, Saskatchewan, Canada

Research Site

Berlin, Germany

Research Site

Berlin, Germany

Research Site

Berlin, Germany

Research Site

Berlin, Germany

Research Site

Berlin, Germany

Research Site

Dortmund, Germany

Key Dates

Start Date

April 27, 2015

Primary Completion Date

July 25, 2016

Completion Date

July 25, 2016

Last Updated

October 9, 2018

Enrollment

267

ACTUAL participants

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Aclidinium/Formoterol

DRUG

Placebo

DRUG

Digital Implementation of the German S3 Clinical Practice Guideline for Multimorbidity

NCT06831994

Asthma BronchialeBreast Neoplasms+11 more

View study

RECRUITING

The London COPD Exacerbation Cohort

NCT02755974

Pulmonary Disease, Chronic Obstructive

View study

ACTIVE_NOT_RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 9, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Digital Implementation of the German S3 Clinical Practice Guideline for Multimorbidity

The London COPD Exacerbation Cohort

Evaluating the Clinical Effectiveness of a Patient-specific Silicone Stent

Air Filtration for COPD in VA Population of Veterans

A Study of the Effect of a Nurse Navigator Program on High Risk Patients

PROCHYMAL™ (Human Adult Stem Cells) for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)