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

NCT ID: NCT00242333

Last Updated: 2006-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Brief Summary

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The purpose of this study is to investigate the efficacy, safety and tolerability of AD 237 in patients with chronic obstructive pulmonary disease (COPD).

Detailed Description

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Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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AD 237

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role collaborator

Sosei

INDUSTRY

Sponsor Role lead

Principal Investigators

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Robert G Tansley, MD

Role: STUDY_DIRECTOR

Arakis Ltd

Locations

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Specialized Hospital for Active Treatment Pneumophthysiatric Disease "Kudoglu"

Plovdiv, , Bulgaria

Site Status

Regional Dispensary for Pulmonary Diseases Rousse

Rousse, , Bulgaria

Site Status

5-th Multiprofile Hospital for Active Treatment

Sofia, , Bulgaria

Site Status

MHAT "Alexandrovska"

Sofia, , Bulgaria

Site Status

Specialized Hospital for Active Treatment of Pulmonary Diseases "Sveta Sofia"

Sofia, , Bulgaria

Site Status

Central Clinical Base - Medical Institute - Ministry of the Interior

Sofia, , Bulgaria

Site Status

Military Medical Academy

Sofia, , Bulgaria

Site Status

UMHAT "Stara Zagora" EAD

Stara Zagora, , Bulgaria

Site Status

University Hospital

Varna, , Bulgaria

Site Status

Tudogyintezete Nodradgardony

Balassagyarmat, , Hungary

Site Status

III. district Outpatient Clinic

Budapest, , Hungary

Site Status

Diagnostic Units Hungary Ltd

Budapest, , Hungary

Site Status

Gyogyir XI. Kht.II. Tudogondozo Intezet

Budapest, , Hungary

Site Status

Selye Janos Hospital

Komárom, , Hungary

Site Status

Karolona Hospital

Mosonmagyaróvár, , Hungary

Site Status

Szabolcs Szatmar Bereg Megyei Josa Andras Korhaz

Nyíregyháza, , Hungary

Site Status

Fejer County Szent Gyorgy Hospital

Székesfehérvár, , Hungary

Site Status

Vas County Markusovszky Hospital

Szombathely, , Hungary

Site Status

Szpital Wojewodzki

Bielsko-Biala, , Poland

Site Status

10 Wojskowy Szpital Kliniczny Z Poliklinika

Bydgoszcz, , Poland

Site Status

Samodzielny Publiczny Centralny Szpital Kliniczny SAM

Katowice, , Poland

Site Status

Specjalistyczny Osrodek Alergologiczny ALL-MED

Krakow, , Poland

Site Status

Barlicki University Hospital

Lodz, , Poland

Site Status

Szpital ZOZ

Oława, , Poland

Site Status

Wielkopolskie Centrum Chorob Pluc I Gruzlicy

Poznan, , Poland

Site Status

Specjalistyczna Przychodnia Lekarska "Medikard"

Płock, , Poland

Site Status

Spitalul Clinic de Urgenta Floreasca

Bucharest, , Romania

Site Status

Spitalul de Pneumo Ftiziologie "Sf. Stefan"

Bucharest, , Romania

Site Status

Spitalul Clinic "Colentina"

Bucharest, , Romania

Site Status

Institutul National de Boli Infectioase

Bucharest, , Romania

Site Status

Spitalul Clinic de Boli Infectioase si Tropicale " Dr. Victor Babes "

Bucharest, , Romania

Site Status

Institutul de Pneumologie " Marius Nasta "

Bucharest, , Romania

Site Status

Spitalul Clinic de Urgenta Constanta

Constanța, , Romania

Site Status

Countries

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Bulgaria Hungary Poland Romania

Other Identifiers

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P-AD237-005

Identifier Type: -

Identifier Source: org_study_id