Status:
COMPLETED
Single Dose Study to Assess Efficacy and Safety of 4 Doses of LAS100977 in Chronic Obstructive Pulmonary Disease (COPD) Population
Lead Sponsor:
AstraZeneca
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the pharmacodynamics (bronchodilation) of single doses of inhaled LAS100977 in COPD patients.
Eligibility Criteria
Inclusion
- Males and non-pregnant, non-lactating females aged 40 or older.
- Patients with a clinical diagnosis of COPD, according to the GOLD guidelines and stable airway obstruction.
- Patients with a post-salbutamol FEV1 equal to or greater than 30% of the predicted value and less than 80% of the predicted value
- Post-salbutamol FEV1/FVC \< 70% at screening visit.
- Pre-dose FEV1 value of first treatment period within the range of 80-120% of the FEV1 measured at screening prior to salbutamol inhalation.
- Current, or ex-cigarette smokers (former) with a smoking history of at least 10 pack-years.
- Patients whose COPD symptoms at the time of randomisation are stable compared to the Screening visit, according to the investigator's medical judgment.
Exclusion
- History or current diagnosis of asthma.
- A respiratory tract infection or COPD exacerbation in the six weeks prior to the screening visit.
- Patients who have been hospitalised for an acute COPD exacerbation in the 3 months prior to screening visit.
- Clinically significant respiratory conditions other than COPD condition.
- Clinically significant cardiovascular conditions.
- Patients unable to properly use a dry powder or pMDI inhaler device or unable to perform acceptable spirometry.
- Clinically relevant abnormalities laboratory, ECG parameters or physical examination results at the screening evaluation that in the investigator's opinion, preclude study participation.
- 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.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT01425814
Start Date
August 1 2011
End Date
March 1 2012
Last Update
April 10 2017
Active Locations (8)
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1
Almirall Investigational Sites#5
Berlin, Germany, 14050
2
Almirall Investigational Sites#2
Berlin, Germany, 14057
3
Almirall Investigational Sites#6
Frankfurt, Germany, 60596
4
Almirall Investigational Sites#3
Großhansdorf, Germany, 22927