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

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by:
Sosei
ClinicalTrials.gov Identifier:
NCT00242333
First received: October 19, 2005
Last updated: May 15, 2006
Last verified: May 2006
  Purpose

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 Intervention Phase
COPD
Drug: AD 237
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by Sosei:

Primary Outcome Measures:
  • Pulmonary function

Secondary Outcome Measures:
  • Pulmonary function

Estimated Enrollment: 300
Study Start Date: October 2005
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00242333

Locations
Bulgaria
Specialized Hospital for Active Treatment Pneumophthysiatric Disease "Kudoglu"
Plovdiv, Bulgaria, 4000
Regional Dispensary for Pulmonary Diseases Rousse
Rousse, Bulgaria, 7002
Central Clinical Base – Medical Institute – Ministry of the Interior
Sofia, Bulgaria, 1606
MHAT “Alexandrovska”
Sofia, Bulgaria, 1431
5-th Multiprofile Hospital for Active Treatment
Sofia, Bulgaria, 1233
Military Medical Academy
Sofia, Bulgaria, 1606
Specialized Hospital for Active Treatment of Pulmonary Diseases "Sveta Sofia"
Sofia, Bulgaria, 1431
UMHAT “Stara Zagora” EAD
Stara Zagora, Bulgaria, 6003
University Hospital
Varna, Bulgaria, 9010
Hungary
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
Poland
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
Romania
Institutul National de Boli Infectioase
Bucharest, Romania, 21105
Spitalul de Pneumo Ftiziologie “Sf. Stefan”
Bucharest, Romania, 20122
Spitalul Clinic "Colentina"
Bucharest, Romania, 20125
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 Floreasca
Bucharest, Romania, 11641
Spitalul Clinic de Urgenta Constanta
Constanta, Romania, 900591
Sponsors and Collaborators
Sosei
Novartis
Investigators
Study Director: Robert G Tansley, MD Arakis Ltd
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00242333     History of Changes
Other Study ID Numbers: P-AD237-005
Study First Received: October 19, 2005
Last Updated: May 15, 2006
Health Authority: Bulgaria: Bulgarian Drug Agency
Hungary: National Institute of Pharmacy
Poland: Ministry of Health
Romania: National Drug Agency

Keywords provided by Sosei:
COPD
COAD
Chronic obstructive pulmonary disease
emphysema
chronic bronchitis

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 23, 2014