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

S

Sosei

Status and phase

Completed
Phase 2

Conditions

COPD

Treatments

Drug: AD 237

Study type

Interventional

Funder types

Industry

Identifiers

NCT00242333
P-AD237-005

Details and patient eligibility

About

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

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

33

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Data sourced from clinicaltrials.gov

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