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

Sponsor

Sosei (Industry)

Overall Status

Completed

CT.gov ID

NCT00242333

Collaborator

Novartis (Industry)

300

Enrollment

Locations

9.1

Patients Per Site

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
COPD	Drug: AD 237	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

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.

Study Start Date :

Oct 1, 2005

Outcome Measures

Primary Outcome Measures

Pulmonary function []

Secondary Outcome Measures

Pulmonary function []

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Specialized Hospital for Active Treatment Pneumophthysiatric Disease "Kudoglu"	Plovdiv	Bulgaria	4000
2	Regional Dispensary for Pulmonary Diseases Rousse	Rousse	Bulgaria	7002
3	5-th Multiprofile Hospital for Active Treatment	Sofia	Bulgaria	1233
4	MHAT "Alexandrovska"	Sofia	Bulgaria	1431
5	Specialized Hospital for Active Treatment of Pulmonary Diseases "Sveta Sofia"	Sofia	Bulgaria	1431
6	Central Clinical Base - Medical Institute - Ministry of the Interior	Sofia	Bulgaria	1606
7	Military Medical Academy	Sofia	Bulgaria	1606
8	UMHAT "Stara Zagora" EAD	Stara Zagora	Bulgaria	6003
9	University Hospital	Varna	Bulgaria	9010
10	Tudogyintezete Nodradgardony	Balassagyarmat	Hungary	2661
11	III. district Outpatient Clinic	Budapest	Hungary	1033
12	Diagnostic Units Hungary Ltd	Budapest	Hungary	1036
13	Gyogyir XI. Kht.II. Tudogondozo Intezet	Budapest	Hungary	1221
14	Selye Janos Hospital	Komarom	Hungary	2900
15	Karolona Hospital	Mosonmagyarovar	Hungary	9200
16	Szabolcs Szatmar Bereg Megyei Josa Andras Korhaz	Nyiregyhaza	Hungary	4400
17	Fejer County Szent Gyorgy Hospital	Szekesfehervar	Hungary	8001
18	Vas County Markusovszky Hospital	Szombathely	Hungary	9700
19	Szpital Wojewodzki	Bielsko-Biala	Poland	43-316
20	10 Wojskowy Szpital Kliniczny Z Poliklinika	Bydgoszcz	Poland	85-681
21	Samodzielny Publiczny Centralny Szpital Kliniczny SAM	Katowice	Poland	40-752
22	Specjalistyczny Osrodek Alergologiczny ALL-MED	Krakow	Poland	31-023
23	Barlicki University Hospital	Lodz	Poland	90-153
24	Szpital ZOZ	Olawa	Poland	55-200
25	Specjalistyczna Przychodnia Lekarska "Medikard"	Plock	Poland	09-402
26	Wielkopolskie Centrum Chorob Pluc I Gruzlicy	Poznan	Poland	60-569
27	Spitalul Clinic de Urgenta Floreasca	Bucharest	Romania	11641
28	Spitalul de Pneumo Ftiziologie "Sf. Stefan"	Bucharest	Romania	20122
29	Spitalul Clinic "Colentina"	Bucharest	Romania	20125
30	Institutul National de Boli Infectioase	Bucharest	Romania	21105
31	Spitalul Clinic de Boli Infectioase si Tropicale " Dr. Victor Babes "	Bucharest	Romania	30317
32	Institutul de Pneumologie " Marius Nasta "	Bucharest	Romania	50159
33	Spitalul Clinic de Urgenta Constanta	Constanta	Romania	900591