NCT00242333

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).

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_2

Geographic Reach
4 countries

33 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2005

Completed
Last Updated

May 16, 2006

Status Verified

May 1, 2006

First QC Date

October 19, 2005

Last Update Submit

May 15, 2006

Conditions

COPD

Keywords

COPDCOADChronic obstructive pulmonary diseaseemphysemachronic bronchitis

Outcome Measures

Primary Outcomes (1)

  • Pulmonary function

Secondary Outcomes (1)

  • Pulmonary function

Interventions

AD 237DRUG

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • History of asthma, atopy or allergic rhinitis.
  • Other serious respiratory or other medical conditions which may interfere with the outcome of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (33)

Specialized Hospital for Active Treatment Pneumophthysiatric Disease "Kudoglu"

Plovdiv, 4000, Bulgaria

Location

Regional Dispensary for Pulmonary Diseases Rousse

Rousse, 7002, Bulgaria

Location

5-th Multiprofile Hospital for Active Treatment

Sofia, 1233, Bulgaria

Location

MHAT "Alexandrovska"

Sofia, 1431, Bulgaria

Location

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

Sofia, 1431, Bulgaria

Location

Central Clinical Base - Medical Institute - Ministry of the Interior

Sofia, 1606, Bulgaria

Location

Military Medical Academy

Sofia, 1606, Bulgaria

Location

UMHAT "Stara Zagora" EAD

Stara Zagora, 6003, Bulgaria

Location

University Hospital

Varna, 9010, Bulgaria

Location

Tudogyintezete Nodradgardony

Balassagyarmat, 2661, Hungary

Location

III. district Outpatient Clinic

Budapest, 1033, Hungary

Location

Diagnostic Units Hungary Ltd

Budapest, 1036, Hungary

Location

Gyogyir XI. Kht.II. Tudogondozo Intezet

Budapest, 1221, Hungary

Location

Selye Janos Hospital

Komárom, 2900, Hungary

Location

Karolona Hospital

Mosonmagyaróvár, 9200, Hungary

Location

Szabolcs Szatmar Bereg Megyei Josa Andras Korhaz

Nyíregyháza, 4400, Hungary

Location

Fejer County Szent Gyorgy Hospital

Székesfehérvár, 8001, Hungary

Location

Vas County Markusovszky Hospital

Szombathely, 9700, Hungary

Location

Szpital Wojewodzki

Bielsko-Biala, 43-316, Poland

Location

10 Wojskowy Szpital Kliniczny Z Poliklinika

Bydgoszcz, 85-681, Poland

Location

Samodzielny Publiczny Centralny Szpital Kliniczny SAM

Katowice, 40-752, Poland

Location

Specjalistyczny Osrodek Alergologiczny ALL-MED

Krakow, 31-023, Poland

Location

Barlicki University Hospital

Lodz, 90-153, Poland

Location

Szpital ZOZ

Oława, 55-200, Poland

Location

Wielkopolskie Centrum Chorob Pluc I Gruzlicy

Poznan, 60-569, Poland

Location

Specjalistyczna Przychodnia Lekarska "Medikard"

Płock, 09-402, Poland

Location

Spitalul Clinic de Urgenta Floreasca

Bucharest, 11641, Romania

Location

Spitalul de Pneumo Ftiziologie "Sf. Stefan"

Bucharest, 20122, Romania

Location

Spitalul Clinic "Colentina"

Bucharest, 20125, Romania

Location

Institutul National de Boli Infectioase

Bucharest, 21105, Romania

Location

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

Bucharest, 30317, Romania

Location

Institutul de Pneumologie " Marius Nasta "

Bucharest, 50159, Romania

Location

Spitalul Clinic de Urgenta Constanta

Constanța, 900591, Romania

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveEmphysemaBronchitis, Chronic

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchitisRespiratory Tract InfectionsInfectionsBronchial Diseases

Study Officials

  • Robert G Tansley, MD

    Arakis Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 19, 2005

First Posted

October 20, 2005

Study Start

October 1, 2005

Last Updated

May 16, 2006

Record last verified: 2006-05

Locations

PL(8)RO(7)BU(9)HU(9)