Efficacy of LAMA Added to ICS in Treatment of Asthma

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the superiority of the glycopyrrolate bromide (CHF 5259 pMDI) versus placebo on top of QVAR® pMDI, in terms of lung functions parameters, as well as to assess its safety.

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

Details

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

Criteria

Inclusion Criteria:

• History of asthma ≥ 5 years and diagnosed before 40 years old

• Uncontrolled asthma on low-medium doses of Inhaled CorticoSteroid (ICS) with ACQ (Asthma Control Questionnaire) ≥1.5

• Pre-bronchodilator FEV1 ≥40% and <90% of their predicted normal value

• Positive reversibility test

Exclusion Criteria:

• Pregnant or lactating women

• Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)

• Patients treated for asthma exacerbation 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