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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.
 
ClinicalTrials.gov Identifier: NCT00242333
Recruitment Status : Completed
First Posted : October 20, 2005
Last Update Posted : May 16, 2006
Sponsor:
Collaborator:
Novartis
Information provided by:
Sosei

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

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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

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, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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 ClinicalTrials.gov identifier (NCT number): NCT00242333


Locations
Show Show 33 study locations
Sponsors and Collaborators
Sosei
Novartis
Investigators
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Study Director: Robert G Tansley, MD Arakis Ltd

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ClinicalTrials.gov Identifier: NCT00242333    
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:
COPD
COAD
Chronic obstructive pulmonary disease
emphysema
chronic bronchitis