A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicentre, Phase II Study to Assess The Efficacy of AZD9056 (single oral 400 mg dose) when Administered for 4 Weeks in Patients with Moderate to Severe COPD

AstraZeneca AB0 sites0 target enrollmentSeptember 22, 2005

Overview

No summary available.

Registry

who.int

Start Date

September 22, 2005

End Date

September 29, 2006

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•1\.Provision of signed and dated informed consent (prior to any study\-related procedures or restrictions)
•2\.Male or female aged between 40 to 80 years
•3\.Females must be using 2 forms of contraception (eg, oral contraception and barrier method) for the duration of the study, unless they are surgically sterile or post?menopausal
•4\.Clinical diagnosis of COPD (documented in patient notes) for more than 2 years
•5\.Patients must not be at risk of active tuberculosis including disease reactivation as indicated by a negative result in all of the following:
•(i)Past medical history of TB or current symptoms suggestive of active TB
•(ii)A positive tuberculin (Mantoux) test in response to intradermally dosed tuberculin (either PPD RT23 SSI, 2 Tuberculin units/0\.1 mL, solution for injection (SSI, Copenhagen Denmark) or an equivalent local tuberculin preparation)
•(iii)Positive T SPOT™ \-TB (Elispot) test
•(iv)Chest x\-ray (taken within the previous 2 years) suggesting healed or active TB
•6\.Current or ex\-smokers with a smoking history of at least 10 years

•1\.Pregnant or lactating females
•2\.A history of asthma or seasonal allergic rhinitis with disease onset before 40 years of age
•3\.Concomitant diagnosis of clinical bronchiectasis, sarcoidosis or pulmonary disease other than COPD
•4\.Requirements for regular oxygen therapy
•5\.Any other clinically significant disease or disorder (including insulin\-dependent diabetes and active peptic ulceration) which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subject’s ability to participate in the study
•6\.Known HIV infection or positive tests for Hepatitis B or C
•7\.An exacerbation of COPD (defined as, an increase in respiratory symptoms requiring hospitalisation and/or a course of oral glucocorticosteroids and/or antibiotics (either prescribed or self\-administered) within 8 weeks of Visit 1
•8\.Use of antibiotics within 4 weeks of Visit 1
•9\.Receipt of live, or live attenuated, vaccines within 4 weeks of Visit 1
•10\.History of malignancy and neoplastic disease (however, patients who have been successfully treated for basal or squamous cell carcinoma of the skin more than 5 years ago, may be included)