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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

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

Key facts

Study ID

NCT03137784

Run by

Novartis Pharmaceuticals

People needed

148

Starts

2017-05-04

Expected to finish

2017-12-29

Last updated by the study team

2019-01-16

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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sarcoidosis, interstitial lung disease, cystic fibrosis, and tuberculosis (unless tuberculosis is confirmed as no longer active by imaging).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).

Where it is running

• Novartis Investigative Site — North Dartmouth, Massachusetts, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — Skillman, New Jersey, United States
• Novartis Investigative Site — Raleigh, North Carolina, United States
• Novartis Investigative Site — Medford, Oregon, United States
• Novartis Investigative Site — El Paso, Texas, United States
• Novartis Investigative Site — Erpent, Belgium
• Novartis Investigative Site — Hasselt, Belgium
• Novartis Investigative Site — Mechelen, Belgium
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Frankfurt, Germany
• Novartis Investigative Site — Großhansdorf, Germany
• Novartis Investigative Site — Lübeck, Germany
• Novartis Investigative Site — Wiesbaden, Germany
• Novartis Investigative Site — Shinjuku-ku, Tokyo, Japan
• Novartis Investigative Site — Toshima-ku, Tokyo, Japan
• Novartis Investigative Site — Daugavpils, LVA, Latvia
• Novartis Investigative Site — Riga, Latvia
• Novartis Investigative Site — Riga, Latvia
• Novartis Investigative Site — Klaipėda, Lithuania
• Novartis Investigative Site — Klaipėda, Lithuania

Full record on ClinicalTrials.gov

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