NCT01176903

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

Randomized, Double-blind, Placebo-controlled, Cross-over Study to Investigate the Bronchodilator Efficacy and Safety After Single and Repeated Administrations of Different Doses of Glycopyrrolate Via pMDI in Moderate to Severe COPD Patients.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The study is divided into two parts: \- Part 1 will be conducted according to a single-centre, randomized, double-blind, placebo-controlled, single-dose escalation, alternating crossover design in two groups of COPD patients. Treatments to be administered on Part 1 (SD1, SD2, SD3, SD4, SD5, SP). The primary objective of Part 1 is the evaluation of the safety and tolerability of Glyco after single administration. \- Part 2 will be conducted according to a single-centre, randomized, double-blind, placebo-controlled, 4-period, 4-treatment, repeated dose cross-over design followed by an open-label extension period with tiotropium. Treatments administered on Part 2 (MD1, MD2, MD3, MP, Tiotropium). On the last treatment day in the morning, Formoterol 12 µg will be administered to all patients on top of placebo or Glyco or Tiotropium. The primary objective of Part 2 is the evaluation of the efficacy of Glyco after repeated administration. Part 2 will start after a safety review of the results obtained from Part 1.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	Glycopyrrolate	pressurized metered dose inhaler
DRUG	Tiotropium	inhalation powder, hard capsule
DRUG	placebo	pressurized metered dose inhaler

Timeline

• Start date: 2010-08-01
• Primary completion: 2010-11-01
• Completion: 2011-08-01
• First posted: 2010-08-06
• Last updated: 2021-10-29

Locations

1 site across 1 country: United Kingdom