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To Assess the Long-term Safety, Tolerability and Efficacy of Aclidinium Bromide at Two Dose Levels in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe, Sta

2014-08-27 03:16:51 | BioPortfolio

Summary

The purpose of this study is to evaluate the safety, tolerability and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe, stable chronic obstructive pulmonary disease. The study will be 56 weeks in duration; a 52-week treatment period and a 2-week follow up phone call, preceded by a 2-week run-in period. All patients will be randomized to one of two doses of aclidinium bromide.

Study Design

Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Chronic Obstructive Pulmonary Disease

Intervention

aclidinium bromide, aclidinium bromide

Location

Forest Investigative Site 1162
Birmingham
Alabama
United States
35209

Status

Active, not recruiting

Source

Forest Laboratories

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:51-0400

Clinical Trials [3507 Associated Clinical Trials listed on BioPortfolio]

A Drug Utilisation Post-authorisation Study of New Users of Aclidinium Bromide (Monotherapy or in Combination)

DUS1 and DUS2 are descriptive drug utilisation studies in new users of aclidinium bromide in Europe. The objectives of DUS1 and DUS2 are to describe the characteristics and patterns of us...

Efficacy and Safety Study of Two Fixed-dose Combinations of Aclidinium Bromide With Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo

The purpose of this study is to evaluate the efficacy of this multicenter, randomized, double-blind, placebo-controlled, 4-period, incomplete-block crossover, dose-ranging study comparing ...

Efficacy and Safety of Aclidinium Bromide for Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to assess the efficacy (effectiveness) and safety of aclidinium bromide doses as compared to placebo in the treatment of moderate to severe chronic obstructive...

Efficacy, Safety and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28-Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonar

The purpose of this Phase III study is to evaluate the long-term safety and tolerability of two fixed-dose combinations of inhaled aclidinium bromide/formoterol fumarate, aclidinium bromid...

Efficacy of Aclidinium Bromide Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients

The main purpose of this study is to evaluate the efficacy, safety and tolerability of multiple doses of inhaled aclidinium bromide in moderate to severe COPD patients.

PubMed Articles [21362 Associated PubMed Articles listed on BioPortfolio]

Clinical aspects of gastropathy development in patients with chronic obstructive pulmonary disease.

Introduction: Chronic obstructive pulmonary disease (COPD) is a one of the main reasons of disability and mortality in the world. The essential attention is dedicated to the combination of COPD and er...

Cardiovascular Outcomes and All-Cause Mortality in Patients with Obstructive Sleep Apnea and Chronic Obstructive Pulmonary Disease (Overlap Syndrome).

The combined impact of chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) on cardiovascular outcomes remains controversial.

Oxygen versus air-driven nebulisers for exacerbations of chronic obstructive pulmonary disease: a randomised controlled trial.

In exacerbations of chronic obstructive pulmonary disease, administration of high concentrations of oxygen may cause hypercapnia and increase mortality compared with oxygen titrated, if required, to a...

Tele-Assisted Palliative Homecare for Advanced Chronic Obstructive Pulmonary Disease: A Feasibility Study.

Despite real needs, very few chronic obstructive pulmonary disease (COPD) patients with life-limiting disease receive a well-organized support for palliative care (PC).

The importance of left heart disease as a cause of pulmonary hypertension in COPD.

Chronic obstructive pulmonary disease is a common respiratory condition that presents in varying degrees of severity and can be complicated by further co-morbidities. Up to a third can also have pulmo...

Medical and Biotech [MESH] Definitions

A scopolamine derivative and CHOLINERGIC ANTAGONIST that functions as a BRONCHODILATOR AGENT. It is used in the treatment of CHRONIC OBSTRUCTIVE PULMONARY DISEASE.

A combined pharmaceutical preparation of Ipratropium Bromide and Albuterol Sulfate that is used to treat the symptoms of ASTHMA and CHRONIC OBSTRUCTIVE PULMONARY DISEASE.

A disease of chronic diffuse irreversible airflow obstruction. Subcategories of COPD include CHRONIC BRONCHITIS and PULMONARY EMPHYSEMA.

Hypertrophy and dilation of the RIGHT VENTRICLE of the heart that is caused by PULMONARY HYPERTENSION. This condition is often associated with pulmonary parenchymal or vascular diseases, such as CHRONIC OBSTRUCTIVE PULMONARY DISEASE and PULMONARY EMBOLISM.

Cyanogen bromide (CNBr). A compound used in molecular biology to digest some proteins and as a coupling reagent for phosphoroamidate or pyrophosphate internucleotide bonds in DNA duplexes.

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