Efficacy, Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) - Full Text View

Purpose

The purpose of this Phase III study is to assess the maintenance bronchodilator effects of the fixed dose combination versus monotherapies. This study will also assess the effects of the fixed dose combination in terms of COPD symptoms, disease related health status and the long-term safety and tolerability of the fixed dose combination. This study will include a 24 week treatment period, preceding by a run-in period, followed by a two week follow up visit. All patients will be randomized to one of four treatment arms or placebo.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: Aclidinium Bromide/Formoterol Fumarate Drug: Aclidinium Bromide Drug: Formoterol Fumarate Drug: placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase III, Randomized, Double-blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo for 24- Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Formic acid Formoterol fumarate Formoterol Arformoterol Tartrate Aclidinium bromide

U.S. FDA Resources

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:

Morning pre-dose (trough) Forced Expiratory Volume in one second (FEV1) at Week 24 [ Time Frame: Change from Basline (Week 0) to 24 Weeks ] [ Designated as safety issue: No ]
Morning one-hour post-dose FEV1 at Week 24 [ Time Frame: Change from Basline (Week 0) to 24 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in George's Respiratory Questionnaire (SGRQ) total score [ Time Frame: Change from Basline (Week 0) to 24 Weeks ] [ Designated as safety issue: No ]
Improvement in Transition Dyspnea Index (TDI) score [ Time Frame: Change from Basline (Week 0) to 24 Weeks ] [ Designated as safety issue: No ]

Enrollment:	1692
Study Start Date:	September 2011
Study Completion Date:	March 2013
Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Aclidinium/formoterol Fixed Dose Combination (FDC) high dose	Drug: Aclidinium Bromide/Formoterol Fumarate Inhaled Aclidinium/formoterol FDC high dose, twice per day
Experimental: 2 Aclidinium/formoterol Fixed Dose Combination (FDC) low dose	Drug: Aclidinium Bromide/Formoterol Fumarate Inhaled Aclidinium/formoterol FDC low dose, twice per day
Active Comparator: 3 Aclidinium monotherapy 400 μg	Drug: Aclidinium Bromide Inhaled Aclidinium 400 μg, twice per day
Active Comparator: 4 Formoterol monotherapy 12 μg	Drug: Formoterol Fumarate Inhaled Formoterol 12 μg, twice per day
Placebo Comparator: 5 Placebo	Drug: placebo Inhaled dose-matched placebo, twice per day

Eligibility

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

Criteria

Inclusion Criteria:

Current or former cigarette smokers with a cigarette smoking history of at least 10 pack-years
A diagnosis of stable moderate to severe COPD and stable airway obstruction as defined by the Global Initiative for Chronic Obstructive Lung Disease guidelines and stable airway obstruction.

Exclusion Criteria:

Patients who have been hospitalized for an acute COPD exacerbation within three months prior to Visit 1
Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the six weeks before Visit 1.
Patients with any clinically significant respiratory conditions other than COPD
Clinical history that suggests that the patient has asthma as opposed to COPD
Chronic use of oxygen therapy ≥ 15 hours/day
Patients with clinically significant cardiovascular conditions
Patients with a history of hypersensitivity reaction to inhaled anticholinergics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01437397

Show 222 Study Locations

Sponsors and Collaborators

Forest Laboratories

Almirall, S.A.

Investigators

Study Director:

Thomas Goodin, PhD

Forest Laboratories

More Information

No publications provided

Responsible Party:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT01437397 History of Changes
Other Study ID Numbers:	LAC-MD-31
Study First Received:	September 19, 2011
Last Updated:	April 5, 2013
Health Authority:	United States: Food and Drug Administration Canada: Health Canada Australia: Department of Health and Ageing Therapeutic Goods Administration New Zealand: Medsafe

Keywords provided by Forest Laboratories:

COPD
Chronic Obstructive Pulmonary Disease
Chronic Bronchitis
Emphysema

Airflow Obstruction, Chronic
Chronic Airflow Obstruction
Chronic Obstructive Airway Disease
Chronic Obstructive Lung Disease

Additional relevant MeSH terms:

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bromides
Formoterol
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic beta-2 Receptor Agonists

Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on May 19, 2013

Efficacy, Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAC)