Safety and Efficacy Study of Glyco pMDI After Single and Repeated Administration

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and the efficacy of Glycopyrrolate as pMDI after single and repeated administration.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiesi Farmaceutici S.p.A.
• Treatments: Glycopyrrolate; Tiotropium Bromide

Criteria

Inclusion Criteria:

• Males and females patients aged 40-75 years;

• Written informed consent obtained;

• Diagnosis of moderate-severe COPD, according to the GOLD guidelines;

• Current or ex-smokers with a smoking history of ≥ 10 pack-years

• Post bronchodilator FEV1 between 40% and 80% predicted values (40% ≤ FEV1 < 80%), documented at screening visit ;

• Post bronchodilator FEV1/Forced Vital Capacity (FEV1/FVC) ≤ 0.70 (absolute value) documented at screening visit;

• Airway reversibility of at least 100 mL within 30 to 45 minutes after inhalation of ipratropium 80µg.

Exclusion Criteria:

• History of chronic or seasonal allergy

• Blood eosinophil count above 600 per µl

• Clinically relevant findings on physical examination laboratory and ECG parameters at screening

• Occurrence of clinically relevant abnormalities in the 24-h Holter ECG recording at screening;

• Significant disease not related to COPD (eg. Myocardial infarction, stroke within the preceding 6 months);

• Respiratory tract infection (including upper tract) 4 weeks prior to study entry requiring changing treatment;

• Patients requiring oxygen therapy on a daily basis for chronic hypoxemia;

• History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency, or any other significant lung disease which is considered to be clinically significant by the investigator.

• Intolerance/hypersensitivity or any contra-indication to treatment with M3 Antagonist or any of the excipients contained in the formulations used in the study.

• History of alcohol or substance abuse that in the opinion of the Investigator may be of clinical significance.

• Patients treated with slow-release oral or parental corticosteroids 8 weeks prior to Screening Visit.

• Patients treated with tiotropium in the 10 days prior to the Screening Visit;

• Pregnant or lactating women and female or male subjects not willing to use an acceptable method of contraception.