Clinical Trials Logo
  1. Home
  2. Other
  3. NCT01462942

Long-term Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-Dose Combination

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:
Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-dose Combinations Compared With Individual Components and Placebo When Administered to Patients With Stable Chronic Obstructive Pulmonary Disease.

Clinical Trial Summary

The objective is to provide data supporting the use of LAS40464 as an efficacious and safe maintenance bronchodilator treatment of patients with Chronic Obstructive Pulmonary Disease (COPD).

Clinical Trial Description

This Phase III study seeks to confirm the long-term bronchodilator efficacy and effects on COPD related health status and other secondary parameters as well as the safety of two doses of the combination of aclidinium bromide/formoterol FDC (FDC 400/12 μg and 400/6 μg) compared with aclidinium bromide monotherapy 400 μg, formoterol monotherapy 12 μg and placebo. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01462942
Study type Interventional
Source AstraZeneca
Contact
Status Completed
Phase Phase 3
Start date October 2011
Completion date January 2013
View Details
See also
  Status Clinical Trial Phase
Completed NCT03282019 - Study of Long-term HFNC for COPD Patients With HOT N/A
Completed NCT05573464 - A Study to Assess the Safety of Budesonide/Glycopyrronium/Formoterol Fumarate With the Hydrofluoroolefin Propellant in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease Phase 3
Recruiting NCT06040086 - Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations Phase 3
Not yet recruiting NCT06376994 - Multi-Center Clean Air Randomized Controlled Trial in COPD Phase 3
Completed NCT02797392 - Feasibility of a Preventive Program Against Lifestyle Related Diseases N/A
Completed NCT02926534 - Cross-Sectional Study of COPD Prevalence Among Smokers, Ex-smokers and Never-Smokers in Almaty, Kazakhstan N/A
Completed NCT02728674 - Management of Patients With Respiratory Symptoms in Sweden N/A
Recruiting NCT02415478 - Bronchioscopic Lung Volume Reduction (BLVR) N/A
Completed NCT02518139 - A 52-Week Parallel Group Safety Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD) Phase 3
Completed NCT02512510 - Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD) Phase 3
Completed NCT03487406 - Anti-platelet Therapy in the Prevention of Cardiovascular Disease in Patients With COPD (APPLE-COPD: ICON 2) Phase 2
Completed NCT02459080 - Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD) Phase 3
Completed NCT02774226 - Long Term Nitric Oxide Bioavailability on Vascular Health in Chronic Obstructive Pulmonary Disease Phase 2
Completed NCT01893476 - A Pragmatic Cluster Trial of a Tailored Intervention to Improve COPD Management N/A
Withdrawn NCT01908933 - Study of the AeriSeal System Treatment in Patients With Advanced Non-Upper Lobe Predominant Heterogeneous Emphysema Phase 3
Completed NCT01615484 - Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability N/A
Completed NCT01908140 - Study of Aclidinium Bromide/Formoterol Fumarate Compared With Salmeterol/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD) Phase 3
Completed NCT01701869 - Microbiology & Immunology of the Chronically-inflamed Airway N/A
Recruiting NCT02527486 - Seoul National University Airway Registry N/A
Withdrawn NCT01377428 - Efficacy of Indacaterol 150 µg Versus Formoterol Phase 4