Single Dose Study to Assess Efficacy and Safety of 4 Doses of LAS100977 in Chronic Obstructive Pulmonary Disease (COPD) Population

Launched by ASTRAZENECA · Aug 29, 2011

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Males and non-pregnant, non-lactating females aged 40 or older.
• • 2. Patients with a clinical diagnosis of COPD, according to the GOLD guidelines and stable airway obstruction.
• • 3. Patients with a post-salbutamol FEV1 equal to or greater than 30% of the predicted value and less than 80% of the predicted value
• • 4. Post-salbutamol FEV1/FVC \< 70% at screening visit.
• • 5. Pre-dose FEV1 value of first treatment period within the range of 80-120% of the FEV1 measured at screening prior to salbutamol inhalation.
• • 6. Current, or ex-cigarette smokers (former) with a smoking history of at least 10 pack-years.
• • 7. Patients whose COPD symptoms at the time of randomisation are stable compared to the Screening visit, according to the investigator's medical judgment.
• Exclusion Criteria:
• • 1. History or current diagnosis of asthma.
• • 2. A respiratory tract infection or COPD exacerbation in the six weeks prior to the screening visit.
• • 3. Patients who have been hospitalised for an acute COPD exacerbation in the 3 months prior to screening visit.
• • 4. Clinically significant respiratory conditions other than COPD condition.
• • 5. Clinically significant cardiovascular conditions.
• • 6. Patients unable to properly use a dry powder or pMDI inhaler device or unable to perform acceptable spirometry.
• • 7. Clinically relevant abnormalities laboratory, ECG parameters or physical examination results at the screening evaluation that in the investigator's opinion, preclude study participation.
• • 8. Patients who intend to use any concomitant medication not permitted by this protocol or who have not undergone the required washout period for a particular prohibited medication.