Status:
UNKNOWN
Impact of Inhaled PT003 on Complexity and Variability of Tidal Breathing and Oscillatory Mechanics in Stable COPD Patient
Lead Sponsor:
University Hospital, Lille
Collaborating Sponsors:
AstraZeneca
Conditions:
Copd
Eligibility:
All Genders
40-75 years
Phase:
PHASE2
Brief Summary
Prospective, single-arm, open label, multicentre, phase II pilot study to evaluate the immediate and short term (one month) impact of a new long acting double bronchodilator on innovative parameters i...
Eligibility Criteria
Inclusion
- Female or male subjects aged 40-75 years Documented COPD in stable condition FEV1 between 30 % and 70 % predicted (post bronchodilator) Significant dyspnea with a mMRC dyspnea scale
Exclusion
- History or current diagnosis of asthma or ACO (asthma-COPD overlap syndrome)
- Respiratory infection or COPD exacerbation within 6 weeks (2 months if it resulted in hospitalization) prior to screening
- Clinically significant or relevant cardiovascular conditions, laboratory tests, electrocardiogram (ECG) parameters
- Severe renal impairment eGFR \< 30
- Narrow-angle glaucoma that, in the opinion of the Investigator, has not been adequately treated.
- Symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retention that is clinically significant
Key Trial Info
Start Date :
January 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2023
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04087590
Start Date
January 14 2020
End Date
February 1 2023
Last Update
August 19 2022
Active Locations (1)
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1
Hop Calmette Chu Lille
Lille, France, 59000