EUCTR2005-004110-32-SE
Active, not recruiting
Not Applicable
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
ConditionsChronic Obstructive Pulmonary Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Obstructive Pulmonary Disease
- Sponsor
- AstraZeneca AB
- Enrollment
- 162
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •5\. Sputum producers with a history of chronic expectoration on most days of most
- •weeks of the year. Patients must produce at least 3 g of sputum during the morning
- •of Visit 1\. (If this criterion is not fulfilled and it is felt that the weight does not
Exclusion Criteria
- •Any of the following is regarded as a criterion for exclusion from the study:
- •1\. Pregnant or lactating females
- •2\. A history of asthma
- •3\. A history of seasonal allergic rhinitis with disease onset before 40 years of age
- •4\. Concomitant diagnosis of clinical bronchiectasis, sarcoidosis or pulmonary disease
- •other than COPD
- •5\. Requirements for regular oxygen therapy
- •6\. 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
Outcomes
Primary Outcomes
Not specified
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