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| Sponsor: | Almirall, S.A. |
|---|---|
| Collaborator: |
Forest Laboratories |
| Information provided by: | Almirall, S.A. |
| ClinicalTrials.gov Identifier: | NCT01078623 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease |
Drug: Aclidinium and Formoterol Drug: Placebo Drug: Formoterol Drug: Aclidinium |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Control: Placebo Control Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Efficacy, Safety and Tolerability of Two Fixed-Dose Combinations of Aclidinium Bromide With Two Doses of Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo All Administered Twice Daily in Stable, Moderate to Severe Chronic Obstructive Pulmonary Disease Patients. |
| Estimated Enrollment: | 120 |
| Study Start Date: | February 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Formoterol: Active Comparator
Formoterol
|
Drug: Formoterol
Formoterol dose
|
|
Placebo: Placebo Comparator
Placebo
|
Drug: Placebo
Placebo control
|
|
Aclidinium and Formoterol (I): Experimental
Fixed dose combination
|
Drug: Aclidinium and Formoterol
Fixed Dose (I)
|
|
Aclidinium and Formoterol (II): Experimental
Fixed dose combination
|
Drug: Aclidinium and Formoterol
Fixed dose (II)
|
|
Aclidinium: Experimental
Aclidinium
|
Drug: Aclidinium
Aclidinium dose
|
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Czech Republic | |
| Almirall Investigational Sites#3 | |
| Hlucin, Czech Republic, 748 21 | |
| Almirall Investigational Sites#1 | |
| Praha, Czech Republic, 130 00 | |
| Almirall Investigational Sites#2 | |
| Praha, Czech Republic, 150 06 | |
| Almirall Investigational Sites#5 | |
| Rokycany, Czech Republic, 337 01 | |
| Germany | |
| Almirall Investigational Sites#3 | |
| Berlin, Germany, 14059 | |
| Almirall Investigational Sites#5 | |
| Berlín, Germany, 10717 | |
| Almirall Investigational Sites#2 | |
| Donaustauf, Germany, 93093 | |
| Almirall Investigational Sites#6 | |
| Lübeck, Germany, 23538 | |
| Almirall Investigational Sites#4 | |
| Schwerin, Germany, 19055 | |
| Hungary | |
| Almirall Investigational Sites#2 | |
| Komarom, Hungary, 2900 | |
| Almirall Investigational Sites#3 | |
| Komlo, Hungary, 7300 | |
| Almirall Investigational Sites#1 | |
| Szarvas, Hungary, 5540 | |
| Poland | |
| Almirall Investigational Sites#1 | |
| Krakow, Poland, 31-501 | |
| Almirall Investigational Sites#2 | |
| Krakow, Poland, 31-023 | |
| Almirall Investigational Sites#4 | |
| Lublin, Poland, 20-718 | |
| Almirall Investigational Sites#3 | |
| Olawa, Poland, 55-200 | |
| Romania | |
| Almirall Investigational Sites#4 | |
| Bucuresti, Romania, 12384 | |
| Almirall Investigational Sites#9 | |
| Bucuresti, Romania, 11025 | |
| Almirall Investigational Sites#13 | |
| Bucuresti, Romania, 22328 | |
| Almirall Investigational Sites#10 | |
| Cluj, Romania, CLUJ | |
| Almirall Investigational Sites#1 | |
| Constanta, Romania, 900002 | |
| Almirall Investigational Sites#7 | |
| Deva, Romania, 330084 | |
| Almirall Investigational Sites#6 | |
| Iasi, Romania, 700115 | |
| Almirall Investigational Sites#3 | |
| Iasi, Romania, 700305 | |
| Almirall Investigational Sites#14 | |
| Iasi, Romania, 700381 | |
| Almirall Investigational Sites#8 | |
| Oradea, Romania, 410176 | |
| Almirall Investigational Sites#5 | |
| Tg Mures, Romania, 540072 | |
| Almirall Investigational Sites#12 | |
| Timisoara, Romania, 0 | |
More Information
| Responsible Party: | Almirall ( Estrella Garcia ) |
| ClinicalTrials.gov Identifier: | NCT01078623 History of Changes |
| Other Study ID Numbers: | M/40464/26 |
| Study First Received: | March 1, 2010 |
| Last Updated: | August 6, 2010 |
| Health Authority: | Hungary: National Institute of Pharmacy; Czech Republic: State Institute for Drug Control; Germany: Federal Institute for Drugs and Medical Devices; Poland: Ministry of Health; Romania: National Authority for Scientific Research |
|
Bronchitis Chronic Emphysema |
|
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-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 |