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Long-term Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-Dose Combination | Clinical Trials | Clareo Health

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

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.

NCT01462942•AstraZeneca

View on ClinicalTrials.gov

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).

Detailed 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.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adult male or non-pregnant, non-lactating female aged ≥40. Women of childbearing potential are allowed to enter the trial if they show to have a negative serum pregnancy test at the Screening Visit and are using, during the last two months before the Screening Visit, at least one medically approved and highly effective method of birth control defined as those which result in a low failure rate (i.e less than 1% per year) when used consistently and correctly such as implants, injectables, oral contraceptives combined with at least one barrier method, hormonal Intrauterine Devices (IUDs), sexual abstinence or vasectomy of the partner.
•Current or ex-cigarette smoker, with a smoking history of at least 10 pack-years.
•Patient with a clinical diagnosis of stable COPD according to the Global Initiative for Chronic Lung Disease "GOLD" Guidelines at the Screening Visit.
•Patient whose FEV1/FVC (Forced Vital Capacity) at the Screening Visit measured between 10-15 minutes post inhalation of 400 micrograms of salbutamol is \< 70% (i.e., 100 x Post-salbutamol FEV1 /FVC \< 70%).
•Patient with a diagnosis of moderate to severe COPD according to the GOLD Guidelines classification (stages II and III) at the Screening Visit: FEV1 measured between 10-15 minutes post inhalation of 400 micro grams of salbutamol is 30% \< FEV1 \< 80% of the predicted normal value (i.e., 100 x Post-salbutamol FEV1/ Predicted FEV1 must be \< 80% and ≥ 30%).
•Patient must be able to perform repeatable pulmonary function testing for FEV1 according to American Thoracic Society/European Respiratory Society "ATS/ERS" 2005 criteria at Screening Visit.
•Patient who is eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained.

Exclusion Criteria

•History or current diagnosis of asthma.
•Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks before Screening Visit.
•Patient hospitalised for COPD exacerbation within 3 months prior to Screening Visit.
•Clinically significant respiratory conditions defined as:
•* Known active tuberculosis.
•* History of interstitial lung or massive pulmonary thromboembolic disease.
•* Pulmonary resection or lung volume reduction surgery within 12 months prior to Screening Visit.
•* History of lung transplantation.
•* History of bronchiectasis secondary to respiratory diseases others than COPD (e.g., cystic fibrosis, Kartagener's syndrome, etc).
•* Known a1-antitrypsin deficiency.
+27 more criteria

Locations (197)

Almirall Investigational Site #2

Graz, Austria

Almirall Investigational Site #3

Salzburg, Austria

Almirall Investigational Site #3

Edegem, Belgium

Almirall Investigational Site #2

Genk, Belgium

Almirall Investigational Site #6

Rousse, Bulgaria

Almirall Investigational Site #10

Sevlievo, Bulgaria

Almirall Investigational Site #8

Sofia, Bulgaria

Almirall Investigational Site #2

Sofia, Bulgaria

Almirall Investigational Site #11

Sofia, Bulgaria

Almirall Investigational Site #2

Zagreb, Croatia

Key Dates

Start Date

October 1, 2011

Primary Completion Date

January 1, 2013

Completion Date

January 1, 2013

Last Updated

February 15, 2017

Enrollment

2,443

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Aclidinium Bromide/Formoterol Fumarate

DRUG

Aclidinium Bromide/Formoterol Fumarate

DRUG

Aclidinium Bromide

DRUG

Placebo

DRUG

Formoterol Fumarate

DRUG

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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: February 15, 2017Data 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

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

Inclusion Criteria

Exclusion Criteria

cfMSC Stem Cell Therapy Targeting COPD

A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease

Mindful-Breath for People With COPD

The HELlenic Thoracic Society Initiative for CΟPD and CVD

Magnetic Stimulation of Diaphragm in Chronic Obstructive Pulmonary Disease

COPD Exacerbation Modelling Using Unobtrusive Sensors - the TOLIFE Clinical Study A