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

May 15, 2006 updated by: Sosei

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.

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

Study Overview

Status

Completed

Conditions

COPD

Intervention / Treatment

Drug: AD 237

Study Type

Interventional

Enrollment

300

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Bulgaria
- - Plovdiv, Bulgaria, 4000
    - Specialized Hospital for Active Treatment Pneumophthysiatric Disease "Kudoglu"
  - Rousse, Bulgaria, 7002
    - Regional Dispensary for Pulmonary Diseases Rousse
  - Sofia, Bulgaria, 1606
    - Military Medical Academy
  - Sofia, Bulgaria, 1233
    - 5-th Multiprofile Hospital for Active Treatment
  - Sofia, Bulgaria, 1431
    - MHAT "Alexandrovska"
  - Sofia, Bulgaria, 1431
    - Specialized Hospital for Active Treatment of Pulmonary Diseases "Sveta Sofia"
  - Sofia, Bulgaria, 1606
    - Central Clinical Base - Medical Institute - Ministry of the Interior
  - Stara Zagora, Bulgaria, 6003
    - UMHAT "Stara Zagora" EAD
  - Varna, Bulgaria, 9010
    - University Hospital
Hungary
- - Balassagyarmat, Hungary, 2661
    - Tudogyintezete Nodradgardony
  - Budapest, Hungary, 1033
    - III. district Outpatient Clinic
  - Budapest, Hungary, 1036
    - Diagnostic Units Hungary Ltd
  - Budapest, Hungary, 1221
    - Gyogyir XI. Kht.II. Tudogondozo Intezet
  - Komarom, Hungary, 2900
    - Selye Janos Hospital
  - Mosonmagyarovar, Hungary, 9200
    - Karolona Hospital
  - Nyiregyhaza, Hungary, 4400
    - Szabolcs Szatmar Bereg Megyei Josa Andras Korhaz
  - Szekesfehervar, Hungary, 8001
    - Fejer County Szent Gyorgy Hospital
  - Szombathely, Hungary, 9700
    - Vas County Markusovszky Hospital
Poland
- - Bielsko-Biala, Poland, 43-316
    - Szpital Wojewódzki
  - Bydgoszcz, Poland, 85-681
    - 10 Wojskowy Szpital Kliniczny z Polikliniką
  - Katowice, Poland, 40-752
    - Samodzielny Publiczny Centralny Szpital Kliniczny SAM
  - Krakow, Poland, 31-023
    - Specjalistyczny Osrodek Alergologiczny ALL-MED
  - Lodz, Poland, 90-153
    - Barlicki University Hospital
  - Olawa, Poland, 55-200
    - Szpital ZOZ
  - Plock, Poland, 09-402
    - Specjalistyczna Przychodnia Lekarska "Medikard"
  - Poznan, Poland, 60-569
    - Wielkopolskie Centrum Chorob Pluc I Gruzlicy
Romania
- - Bucharest, Romania, 11641
    - Spitalul Clinic de Urgenta Floreasca
  - Bucharest, Romania, 20122
    - Spitalul de Pneumo Ftiziologie "Sf. Stefan"
  - Bucharest, Romania, 20125
    - Spitalul Clinic "Colentina"
  - Bucharest, Romania, 21105
    - Institutul National de Boli Infectioase
  - Bucharest, Romania, 30317
    - Spitalul Clinic de Boli Infectioase si Tropicale " Dr. Victor Babes "
  - Bucharest, Romania, 50159
    - Institutul de Pneumologie " Marius Nasta "
  - Constanta, Romania, 900591
    - Spitalul Clinic de Urgenta Constanta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pulmonary function

Secondary Outcome Measures

Outcome Measure
Pulmonary function

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sosei

Collaborators

Novartis

Investigators

Study Director: Robert G Tansley, MD, Arakis Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Study Registration Dates

First Submitted

October 19, 2005

First Submitted That Met QC Criteria

October 19, 2005

First Posted (ESTIMATE)

October 20, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

May 16, 2006

Last Update Submitted That Met QC Criteria

May 15, 2006

Last Verified

May 1, 2006

More Information

Terms related to this study

Keywords

Other Study ID Numbers

P-AD237-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.