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

Sponsor:	Almirall, S.A.
Collaborator:	Forest Laboratories
Information provided by (Responsible Party):	Almirall, S.A.
ClinicalTrials.gov Identifier:	NCT01001494

Purpose

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.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: Aclidinium bromide Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Efficacy and Safety of Aclidinium Bromide at Two Dose Levels vs Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

U.S. FDA Resources

Further study details as provided by Almirall, S.A.:

Primary Outcome Measures:

Change from baseline in morning pre-dose (through) Forced Expiratory Volume in the first second (FEV1) [ Time Frame: week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in peak FEV1 [ Time Frame: week 24 ] [ Designated as safety issue: No ]
Number (%) of patients achieving a clinically meaningful improvement (≥1-unit) in Transition Dyspnoea Index (TDI) focal score [ Time Frame: week 24 ] [ Designated as safety issue: No ]
Number (%) of patients achieving a clinically meaningful improvement (≥4-units) in Saint George Respiratory Questionnaire (SGRQ) total score [ Time Frame: week 24 ] [ Designated as safety issue: No ]

Enrollment:	828
Study Start Date:	October 2009
Study Completion Date:	November 2010
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Aclidinium bromide 1st arm Aclidinium bromide	Drug: Aclidinium bromide Aclidinium bromide two dose levels administered via Genuair dry powder inhaler during 6 months
Experimental: Aclidininum bromide 2nd arm Aclidininum bromide	Drug: Aclidinium bromide Aclidinium bromide two dose levels administered via Genuair dry powder inhaler during 6 months
Placebo Comparator: Placebo Placebo	Drug: Placebo Placebo

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult male and female patients aged ≥40 with stable moderate to severe COPD (GOLD guidelines).
Post-salbutamol (FEV1) < 80% and ≥30% of predicted normal value and Post-salbutamol FEV1/FVC < 70%.
Current or ex-smokers of ≥10 pack-years.

Exclusion Criteria:

Patients with no history or current diagnosis of asthma.
No evidence of an exacerbation within 6 weeks prior to the screening visit.
No evidence of clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities.
No contraindication to use of anticholinergic drugs such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01001494

Show 106 Study Locations

Sponsors and Collaborators

Almirall, S.A.

Forest Laboratories

Investigators

Study Director:

Estrella Garcia, Ph.D.

Almirall, S.A.

More Information

Additional Information:

Almirall Corporate Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Almirall, S.A.
ClinicalTrials.gov Identifier:	NCT01001494 History of Changes
Other Study ID Numbers:	M/34273/34, ATTAIN
Study First Received:	October 22, 2009
Last Updated:	March 29, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Almirall, S.A.:

Chronic Obstructive Pulmonary Disease
antimuscarinic
COPD

Additional relevant MeSH terms:

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

Bromides
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2012