A Study to Assess the Safety and Efficacy of Different AD 237 Doses in Adults With COPD

Phase 2

Completed

• Conditions: COPD

• Registration Number: NCT00242333
• Lead Sponsor: Sosei

Brief Summary

The purpose of this study is to investigate the efficacy, safety and tolerability of AD 237 in patients with chronic obstructive pulmonary disease (COPD).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-10-19
• Study First Submitted QC: 2005-10-19
• Study First Posted: 2005-10-20
• Status Verified: 2006-05
• Last Update Submitted: 2006-05-15
• Last Update Posted: 2006-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pulmonary function

Secondary Outcome Measures

Name	Time	Method
Pulmonary function

Trial Locations

Locations (33)

Karolona Hospital; 🇭🇺 Mosonmagyarovar, Hungary

Central Clinical Base - Medical Institute - Ministry of the Interior; 🇧🇬 Sofia, Bulgaria

Regional Dispensary for Pulmonary Diseases Rousse; 🇧🇬 Rousse, Bulgaria

UMHAT "Stara Zagora" EAD; 🇧🇬 Stara Zagora, Bulgaria

Fejer County Szent Gyorgy Hospital; 🇭🇺 Szekesfehervar, Hungary

10 Wojskowy Szpital Kliniczny Z Poliklinika; 🇵🇱 Bydgoszcz, Poland

Samodzielny Publiczny Centralny Szpital Kliniczny SAM; 🇵🇱 Katowice, Poland

Specjalistyczna Przychodnia Lekarska "Medikard"; 🇵🇱 Plock, Poland

Wielkopolskie Centrum Chorob Pluc I Gruzlicy; 🇵🇱 Poznan, Poland

Military Medical Academy; 🇧🇬 Sofia, Bulgaria

Diagnostic Units Hungary Ltd; 🇭🇺 Budapest, Hungary

Specialized Hospital for Active Treatment of Pulmonary Diseases "Sveta Sofia"; 🇧🇬 Sofia, Bulgaria

Szabolcs Szatmar Bereg Megyei Josa Andras Korhaz; 🇭🇺 Nyiregyhaza, Hungary

Szpital Wojewodzki; 🇵🇱 Bielsko-Biala, Poland

Specjalistyczny Osrodek Alergologiczny ALL-MED; 🇵🇱 Krakow, Poland

Barlicki University Hospital; 🇵🇱 Lodz, Poland

Szpital ZOZ; 🇵🇱 Olawa, Poland

III. district Outpatient Clinic; 🇭🇺 Budapest, Hungary

University Hospital; 🇧🇬 Varna, Bulgaria

5-th Multiprofile Hospital for Active Treatment; 🇧🇬 Sofia, Bulgaria

Tudogyintezete Nodradgardony; 🇭🇺 Balassagyarmat, Hungary

Selye Janos Hospital; 🇭🇺 Komarom, Hungary

Specialized Hospital for Active Treatment Pneumophthysiatric Disease "Kudoglu"; 🇧🇬 Plovdiv, Bulgaria

MHAT "Alexandrovska"; 🇧🇬 Sofia, Bulgaria

Vas County Markusovszky Hospital; 🇭🇺 Szombathely, Hungary

Spitalul Clinic de Urgenta Constanta; 🇷🇴 Constanta, Romania

Gyogyir XI. Kht.II. Tudogondozo Intezet; 🇭🇺 Budapest, Hungary

Institutul National de Boli Infectioase; 🇷🇴 Bucharest, Romania

Institutul de Pneumologie " Marius Nasta "; 🇷🇴 Bucharest, Romania

Spitalul Clinic de Urgenta Floreasca; 🇷🇴 Bucharest, Romania

Spitalul Clinic de Boli Infectioase si Tropicale " Dr. Victor Babes "; 🇷🇴 Bucharest, Romania

Spitalul de Pneumo Ftiziologie "Sf. Stefan"; 🇷🇴 Bucharest, Romania

Spitalul Clinic "Colentina"; 🇷🇴 Bucharest, Romania