Efficacy and Safety of Two Fixed Dose Combinations of Aclidinium Bromide With Formoterol Fumarate
Summary
The purpose of this multicenter, dose-ranging study is to compare two Fixed-Dose Combinations of aclidinium bromide and formoterol fumarate with placebo, aclidinium bromide and formoterol fumarate, all administered BID in patients with stable, moderate to severe COPD.
Every treatment period is 14-days long and there is a 7-days wash-out period in between them. The trial starts with a run in phase of 10 to 17-days duration and it ends up with a follow up contact 14-days after last treatment dose.
Study Design
Allocation: Randomized, Control: Placebo Control, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Conditions
Chronic Obstructive Pulmonary Disease
Intervention
Aclidinium and Formoterol, Placebo, Formoterol, Aclidinium, Aclidinium and Formoterol
Location
Almirall Investigational Sites#3
Hlucin
Czech Republic
748 21
Status
Recruiting
Source
Almirall, S.A.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01078623
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-07-23T21:09:57-0400
Clinical Trials
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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 ...
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...
This is a multiple dose, randomised, parallel, double blind, double dummy, multicentre and multinational Phase III study to determine the efficacy and safety of Aclidinium bromide/Formoter...
This exploratory study will compare the efficacy of the fixed-dose combination (FDC) of aclidinium bromide and formoterol fumarate once daily in the morning and placebo once in the evening...
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Medical and Biotech [MESH] Definitions
Budesonide, Formoterol Fumarate Drug Combination
A pharmaceutical preparation of budesonide and formoterol fumarate that is used as an ANTI-ASTHMATIC AGENT and for the treatment of CHRONIC OBSTRUCTIVE PULMONARY DISEASE.
Mometasone Furoate, Formoterol Fumarate Drug Combination
A pharmaceutical preparation of mometasone furoate and formoterol fumarate that is used as an inhaled dosage form for the treatment of ASTHMA.
Formoterol Fumarate
An ADRENERGIC BETA-2 RECEPTOR AGONIST with a prolonged duration of action. It is used to manage ASTHMA and in the treatment of CHRONIC OBSTRUCTIVE PULMONARY DISEASE.
Therapeutic Misconception
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
Placebo Effect
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
