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

NCT ID: NCT03137784

Last Updated: 2019-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-04
• Study Completion Date: 2017-12-29

Brief 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

Detailed Description

This study uses a randomized, double-blind, placebo controlled, 3-period cross-over clinical trial design. During a screening epoch patient eligibility will be assessed. The screening epoch will be followed by a 21-day Run-in epoch during which patients will continue their inhaled corticosteroids use but be withdrawn from LABA-treatment and switched to short-acting bronchodilator-rescue medication. After the Run-in period patients will be randomized to one of the 6 treatment sequences and enter the first 7-day study treatment period. Treatment period one is followed by a 10 to 14 days washout period after which patients begin the second 7-day treatment period which is then followed by a second 10 to 14 days washout period followed by the third 7-day treatment period. At the end of each treatment period spirometry will be performed to assess the primary endpoint in terms of trough FEV1. The study population will consist of approximately 144 patients with asthma who have been treated in a stable regimen of ICS/LABA for at least 4 weeks prior to screening.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1(NVA237 50 ug/NVA237 25 ug/placebo)

Treatment sequence: NVA 237 50 ug, 25 ug and placebo

Group Type: OTHER

NVA237 (glycopyrronium bromide)

Intervention Type: DRUG

In each treatment arm, patient will receive NVA237 (glycopyrronium bromide) 25 ug and 50 ug dose

Placebo

Intervention Type: DRUG

In each treatment arm, patient will receive placebo

2(NVA237 50 ug/placebo/NVA237 25 ug)

Treatment sequence: NVA 237 50 ug, placebo and 25 ug

Group Type: OTHER

NVA237 (glycopyrronium bromide)

Intervention Type: DRUG

In each treatment arm, patient will receive NVA237 (glycopyrronium bromide) 25 ug and 50 ug dose

Placebo

Intervention Type: DRUG

In each treatment arm, patient will receive placebo

3 (NVA237 25 ug/NVA237 50 ug/placebo)

Treatment sequence: NVA237 25 ug, 50 ug and placebo

Group Type: OTHER

NVA237 (glycopyrronium bromide)

Intervention Type: DRUG

In each treatment arm, patient will receive NVA237 (glycopyrronium bromide) 25 ug and 50 ug dose

Placebo

Intervention Type: DRUG

In each treatment arm, patient will receive placebo

4 (NVA237 25 ug/placebo/NVA237 50 ug)

Treatment sequence: NVA 237 25 ug, placebo and 50 ug

Group Type: OTHER

NVA237 (glycopyrronium bromide)

Intervention Type: DRUG

In each treatment arm, patient will receive NVA237 (glycopyrronium bromide) 25 ug and 50 ug dose

Placebo

Intervention Type: DRUG

In each treatment arm, patient will receive placebo

5 (placebo/NVA237 50 ug/ NVA237 25 ug)

Treatment sequence: Placebo, NVA237 50 ug and 25 ug

Group Type: OTHER

NVA237 (glycopyrronium bromide)

Intervention Type: DRUG

In each treatment arm, patient will receive NVA237 (glycopyrronium bromide) 25 ug and 50 ug dose

Placebo

Intervention Type: DRUG

In each treatment arm, patient will receive placebo

6 (placebo/ NVA237 25 ug/NVA237 50 ug)

Treatment sequence: placebo, NVA237 25 ug and 50 ug

Group Type: OTHER

NVA237 (glycopyrronium bromide)

Intervention Type: DRUG

In each treatment arm, patient will receive NVA237 (glycopyrronium bromide) 25 ug and 50 ug dose

Placebo

Intervention Type: DRUG

In each treatment arm, patient will receive placebo

Interventions

NVA237 (glycopyrronium bromide)

In each treatment arm, patient will receive NVA237 (glycopyrronium bromide) 25 ug and 50 ug dose

Intervention Type: DRUG

Placebo

In each treatment arm, patient will receive placebo

Intervention Type: DRUG

Eligibility 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

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States; Belgium; Germany; Japan; Latvia; Lithuania

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

CQVM149B2204

Identifier Type: -

Identifier Source: org_study_id