Clinical trial NCT00242333: A Study to Assess the Safety and Efficacy of Different AD 237 Doses in Adults With COPD
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COPD
Keywords: COPD
COAD
Chronic obstructive pulmonary disease
emphysema
chronic bronchitis
Lead sponsor: Sosei
Sponsor class: INDUSTRY
Collaborators: name: Novartis
First posted: 2005-10-20
Enrollment: 300
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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.

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