A Study to Assess the Safety and Efficacy of Different AD 237 Doses in Adults With COPD
This study has been completed.
Sponsor:
Sosei
Collaborator:
Novartis
Information provided by:
Sosei
ClinicalTrials.gov Identifier:
NCT00242333
First received: October 19, 2005
Last updated: May 15, 2006
Last verified: May 2006
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Purpose
The purpose of this study is to investigate the efficacy, safety and tolerability of AD 237 in patients with chronic obstructive pulmonary disease (COPD).
| Condition | Intervention | Phase |
|---|---|---|
|
COPD |
Drug: AD 237 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Multi-Center Randomized, Double-Blind, Parallel Group, Placebo Controlled Study, Including an Additional Open Label Tiotropium Group, to Assess the Efficacy, Safety and Tolerability of 4 Doses of AD 237 Inhaled Once Daily for 28 Days in Subjects With COPD. |
Resource links provided by NLM:
Further study details as provided by Sosei:
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosed with COPD, with symptoms of cough and chronic sputum production and/or dyspnea.
- Post-bronchodilator FEV1 at no more than 65% and at least 30% of the predicted normal value.
- Pre-bronchodilator FEV1/FVC ratio of less than 70%.
- Current or ex-smokers with a smoking history of at least 10 pack years.
Exclusion Criteria:
- History of asthma, atopy or allergic rhinitis.
- Other serious respiratory or other medical conditions which may interfere with the outcome of the study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00242333
Locations
| Bulgaria | |
| Specialized Hospital for Active Treatment Pneumophthysiatric Disease "Kudoglu" | |
| Plovdiv, Bulgaria, 4000 | |
| Regional Dispensary for Pulmonary Diseases Rousse | |
| Rousse, Bulgaria, 7002 | |
| Central Clinical Base – Medical Institute – Ministry of the Interior | |
| Sofia, Bulgaria, 1606 | |
| MHAT “Alexandrovska” | |
| Sofia, Bulgaria, 1431 | |
| 5-th Multiprofile Hospital for Active Treatment | |
| Sofia, Bulgaria, 1233 | |
| Military Medical Academy | |
| Sofia, Bulgaria, 1606 | |
| Specialized Hospital for Active Treatment of Pulmonary Diseases "Sveta Sofia" | |
| Sofia, Bulgaria, 1431 | |
| UMHAT “Stara Zagora” EAD | |
| Stara Zagora, Bulgaria, 6003 | |
| University Hospital | |
| Varna, Bulgaria, 9010 | |
| Hungary | |
| Tudogyintezete Nodradgardony | |
| Balassagyarmat, Hungary, 2661 | |
| III. district Outpatient Clinic | |
| Budapest, Hungary, 1033 | |
| Diagnostic Units Hungary Ltd | |
| Budapest, Hungary, 1036 | |
| Gyogyir XI. Kht.II. Tudogondozo Intezet | |
| Budapest, Hungary, 1221 | |
| Selye Janos Hospital | |
| Komarom, Hungary, 2900 | |
| Karolona Hospital | |
| Mosonmagyarovar, Hungary, 9200 | |
| Szabolcs Szatmar Bereg Megyei Josa Andras Korhaz | |
| Nyiregyhaza, Hungary, 4400 | |
| Fejer County Szent Gyorgy Hospital | |
| Szekesfehervar, Hungary, 8001 | |
| Vas County Markusovszky Hospital | |
| Szombathely, Hungary, 9700 | |
| Poland | |
| Szpital Wojewodzki | |
| Bielsko-Biala, Poland, 43-316 | |
| 10 Wojskowy Szpital Kliniczny Z Poliklinika | |
| Bydgoszcz, Poland, 85-681 | |
| Samodzielny Publiczny Centralny Szpital Kliniczny SAM | |
| Katowice, Poland, 40-752 | |
| Specjalistyczny Osrodek Alergologiczny ALL-MED | |
| Krakow, Poland, 31-023 | |
| Barlicki University Hospital | |
| Lodz, Poland, 90-153 | |
| Szpital ZOZ | |
| Olawa, Poland, 55-200 | |
| Specjalistyczna Przychodnia Lekarska “Medikard” | |
| Plock, Poland, 09-402 | |
| Wielkopolskie Centrum Chorob Pluc I Gruzlicy | |
| Poznan, Poland, 60-569 | |
| Romania | |
| Institutul National de Boli Infectioase | |
| Bucharest, Romania, 21105 | |
| Spitalul de Pneumo Ftiziologie “Sf. Stefan” | |
| Bucharest, Romania, 20122 | |
| Spitalul Clinic "Colentina" | |
| Bucharest, Romania, 20125 | |
| Spitalul Clinic de Boli Infectioase si Tropicale " Dr. Victor Babes " | |
| Bucharest, Romania, 30317 | |
| Institutul de Pneumologie " Marius Nasta " | |
| Bucharest, Romania, 50159 | |
| Spitalul Clinic de Urgenta Floreasca | |
| Bucharest, Romania, 11641 | |
| Spitalul Clinic de Urgenta Constanta | |
| Constanta, Romania, 900591 | |
Sponsors and Collaborators
Sosei
Novartis
Investigators
| Study Director: | Robert G Tansley, MD | Arakis Ltd |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00242333 History of Changes |
| Other Study ID Numbers: | P-AD237-005 |
| Study First Received: | October 19, 2005 |
| Last Updated: | May 15, 2006 |
| Health Authority: | Bulgaria: Bulgarian Drug Agency Hungary: National Institute of Pharmacy Poland: Ministry of Health Romania: National Drug Agency |
Keywords provided by Sosei:
|
COPD COAD Chronic obstructive pulmonary disease emphysema chronic bronchitis |
Additional relevant MeSH terms:
|
Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 18, 2013