Bronchodilator Effects and Safety of Glycopyrronium Bromide (25 ug and 50 ug o.d.) in Asthma

• Status: Completed
• Trial end date: 2017-12-29
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to characterize the bronchodilator effects and safety of 25 ug and 50 ug o.d. NVA237 (glycopyrronium bromide) doses compared to placebo in asthma patients

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Bromides; Bronchodilator Agents; Glycopyrrolate

Criteria

Inclusion Criteria:

• Male and female adult patients aged >= 18 or =< 65 years

• Patients with a diagnosis of asthma for a period of at least 1 year receiving daily treatment of ICS/LABA in a stable regimen for >= 4 weeks

• Pre-bronchodilator FEV1 of >= 50% and =< 80% of the predicted normal value and an increase in FEV1 of 12% and >= 200 ml during reversibility testing

Key Exclusion Criteria:

• Patients who have had an asthma exacerbation that required either treatment with systemic corticosteroids for at least 3 days, or an emergency room visit, or hospital treatment within 6 weeks prior to screening and patients with a history of life-threatening asthma attacks

• Patients who have had a respiratory tract infection within 4 weeks prior to screening.

• Patients who have smoked or inhaled tobacco products within the past 6 month of screening.

• Patients with a history of chronic lung diseases other than asthma, including (but not limited to) chronic obstructive pulmonary disease, bronchiectasis, sarcoidosis, interstitial lung disease, cystic fibrosis, and tuberculosis (unless tuberculosis is confirmed as no longer active by imaging).

• Patients on Maintenance Immunotherapy (desensitization) for allergies for at least 3 months prior to Run-in who are expected to change therapy throughout the course of the study.

• Patients who during the Run-in period are shown to be intolerable to LABA withdrawal.

• Patients who have discontinued LAMA therapy in the past (e.g. due to intolerance or perceived lack of efficacy).