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NCT00242333 Clinical Trial

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

COPD Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00242333
Other study ID # P-AD237-005
Secondary ID
Status Completed
Phase Phase 2
First received October 19, 2005
Last updated May 15, 2006
Start date October 2005

Study information
Verified date May 2006
Source Sosei
Contact n/a
Is FDA regulated No
Health authority Bulgaria: Bulgarian Drug AgencyHungary: National Institute of PharmacyPoland: Ministry of HealthRomania: National Drug Agency
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• AD 237

Locations
Country Name City State
Bulgaria Specialized Hospital for Active Treatment Pneumophthysiatric Disease "Kudoglu" Plovdiv
Bulgaria Regional Dispensary for Pulmonary Diseases Rousse Rousse
Bulgaria 5-th Multiprofile Hospital for Active Treatment Sofia
Bulgaria Central Clinical Base – Medical Institute – Ministry of the Interior Sofia
Bulgaria MHAT “Alexandrovska” Sofia
Bulgaria Military Medical Academy Sofia
Bulgaria Specialized Hospital for Active Treatment of Pulmonary Diseases "Sveta Sofia" Sofia
Bulgaria UMHAT “Stara Zagora” EAD Stara Zagora
Bulgaria University Hospital Varna
Hungary Tudogyintezete Nodradgardony Balassagyarmat
Hungary Diagnostic Units Hungary Ltd Budapest
Hungary Gyogyir XI. Kht.II. Tudogondozo Intezet Budapest
Hungary III. district Outpatient Clinic Budapest
Hungary Selye Janos Hospital Komarom
Hungary Karolona Hospital Mosonmagyarovar
Hungary Szabolcs Szatmar Bereg Megyei Josa Andras Korhaz Nyiregyhaza
Hungary Fejer County Szent Gyorgy Hospital Szekesfehervar
Hungary Vas County Markusovszky Hospital Szombathely
Poland Szpital Wojewodzki Bielsko-Biala
Poland 10 Wojskowy Szpital Kliniczny Z Poliklinika Bydgoszcz
Poland Samodzielny Publiczny Centralny Szpital Kliniczny SAM Katowice
Poland Specjalistyczny Osrodek Alergologiczny ALL-MED Krakow
Poland Barlicki University Hospital Lodz
Poland Szpital ZOZ Olawa
Poland Specjalistyczna Przychodnia Lekarska “Medikard” Plock
Poland Wielkopolskie Centrum Chorob Pluc I Gruzlicy Poznan
Romania Institutul de Pneumologie " Marius Nasta " Bucharest
Romania Institutul National de Boli Infectioase Bucharest
Romania Spitalul Clinic "Colentina" Bucharest
Romania Spitalul Clinic de Boli Infectioase si Tropicale " Dr. Victor Babes " Bucharest
Romania Spitalul Clinic de Urgenta Floreasca Bucharest
Romania Spitalul de Pneumo Ftiziologie “Sf. Stefan” Bucharest
Romania Spitalul Clinic de Urgenta Constanta Constanta

Sponsors (2)
Lead Sponsor Collaborator
Sosei Novartis

Countries where clinical trial is conducted

Bulgaria,  Hungary,  Poland,  Romania, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pulmonary function
Secondary Pulmonary function
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