Triple in Asthma Dose Finding

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the optimal dose of CHF 5259 (glycopyrrolate bromide) on top of Foster which provides the optimal additive bronchodilator effect to asthmatic patients whose symptoms are uncontrolled with medium dose of inhaled corticosteroids plus long acting beta2 agonists.

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

Details

• Lead Sponsor: Chiesi Farmaceutici S.p.A.
• Treatments: Beclomethasone; Formoterol Fumarate; Glycopyrrolate

Criteria

Inclusion Criteria:

• Male or female patients aged >=18 years

• Uncontrolled asthma on medium doses of ICS+LABA with ACQ >=1.5

• Pre-bronchodilator FEV1 ≥40% and <80% of their predicted normal value

Exclusion Criteria:

• Pregnant or lactating women

• Diagnosis of COPD

• Patients treated for asthma exacerbations in the 4 weeks prior to study entry

• Patients who are in therapy for gastroesophageal reflux disease

• Patients who have a clinically significant cardiovascular condition