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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00242333
Recruitment Status : Completed
First Posted : October 20, 2005
Last Update Posted : May 16, 2006
Information provided by:

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 Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
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 : October 2005

Primary Outcome Measures :
  1. Pulmonary function

Secondary Outcome Measures :
  1. Pulmonary function

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00242333

Specialized Hospital for Active Treatment Pneumophthysiatric Disease "Kudoglu"
Plovdiv, Bulgaria, 4000
Regional Dispensary for Pulmonary Diseases Rousse
Rousse, Bulgaria, 7002
5-th Multiprofile Hospital for Active Treatment
Sofia, Bulgaria, 1233
MHAT “Alexandrovska”
Sofia, Bulgaria, 1431
Specialized Hospital for Active Treatment of Pulmonary Diseases "Sveta Sofia"
Sofia, Bulgaria, 1431
Central Clinical Base – Medical Institute – Ministry of the Interior
Sofia, Bulgaria, 1606
Military Medical Academy
Sofia, Bulgaria, 1606
UMHAT “Stara Zagora” EAD
Stara Zagora, Bulgaria, 6003
University Hospital
Varna, Bulgaria, 9010
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
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
Spitalul Clinic de Urgenta Floreasca
Bucharest, Romania, 11641
Spitalul de Pneumo Ftiziologie “Sf. Stefan”
Bucharest, Romania, 20122
Spitalul Clinic "Colentina"
Bucharest, Romania, 20125
Institutul National de Boli Infectioase
Bucharest, Romania, 21105
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 Constanta
Constanta, Romania, 900591
Sponsors and Collaborators
Study Director: Robert G Tansley, MD Arakis Ltd Identifier: NCT00242333     History of Changes
Other Study ID Numbers: P-AD237-005
First Posted: October 20, 2005    Key Record Dates
Last Update Posted: May 16, 2006
Last Verified: May 2006

Keywords provided by Sosei:
Chronic obstructive pulmonary disease
chronic bronchitis