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

NCT03137784 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CQVM149B2204
• Study Type: interventional
• Target: 148
• Locations: 6 countries
• Sites: 21

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

Conditions

Asthma

Keywords

asthma,; NVA237,; glycopyrronium bromide; allergic asthma,; allergy triggered asthma,; reactive asthma,; asthma attack,; difficulty breathing

Outcome Measures

Primary Outcomes (1)

• Trough FEV1 After One Week of Treatment, Point Estimate

  To evaluate the bronchodilator effects of NVA237 (25 ug and 50 ug) compared to placebo in terms of trough FEV1 (mean of 23h 15 min and 23 h 45 min post -dose) following 1 week of treatment in the respective treatment period. Trough FEV1 was assessed by performing spirometry measurements in the clinic for each treatment period. For the primary efficacy variable, trough FEV1 is the mean of two measurements taken at 23h 15 min and 23h 45 min post dose.

  Following 1 week of treatment

Secondary Outcomes (9)

• FEV1 AUC (5 Min-1 h) After One Week of Treatment

  Following 1 week of treatment

• FEV1 AUC (5 Min-4 h) After One Week of Treatment

  Following 1 week of treatment

• FEV1 AUC (5 Min - 23 h 45 Min) After One Week of Treatment

  Following 1 week of treatment

• Peak FEV1 During 4 Hours Post-dose After 1 Week of Treatment

  Following 1 week of treatment

• Trough Forced Vital Capacity (FVC) After 1 Week of Treatment

  Following 1 week of treatment

Study Arms (6)

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

OTHER

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

Drug: NVA237 (glycopyrronium bromide); Drug: Placebo

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

OTHER

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

Drug: NVA237 (glycopyrronium bromide); Drug: Placebo

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

OTHER

Treatment sequence: NVA237 25 ug, 50 ug and placebo

Drug: NVA237 (glycopyrronium bromide); Drug: Placebo

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

OTHER

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

Drug: NVA237 (glycopyrronium bromide); Drug: Placebo

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

OTHER

Treatment sequence: Placebo, NVA237 50 ug and 25 ug

Drug: NVA237 (glycopyrronium bromide); Drug: Placebo

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

OTHER

Treatment sequence: placebo, NVA237 25 ug and 50 ug

Drug: NVA237 (glycopyrronium bromide); Drug: Placebo

Interventions

NVA237 (glycopyrronium bromide) DRUG

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

1(NVA237 50 ug/NVA237 25 ug/placebo); 2(NVA237 50 ug/placebo/NVA237 25 ug); 3 (NVA237 25 ug/NVA237 50 ug/placebo); 4 (NVA237 25 ug/placebo/NVA237 50 ug); 5 (placebo/NVA237 50 ug/ NVA237 25 ug); 6 (placebo/ NVA237 25 ug/NVA237 50 ug)

Placebo DRUG

In each treatment arm, patient will receive placebo

1(NVA237 50 ug/NVA237 25 ug/placebo); 2(NVA237 50 ug/placebo/NVA237 25 ug); 3 (NVA237 25 ug/NVA237 50 ug/placebo); 4 (NVA237 25 ug/placebo/NVA237 50 ug); 5 (placebo/NVA237 50 ug/ NVA237 25 ug); 6 (placebo/ NVA237 25 ug/NVA237 50 ug)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (21)

Novartis Investigative Site

North Dartmouth, Massachusetts, 02747, United States

Location

Novartis Investigative Site

St Louis, Missouri, 63141, United States

Location

Novartis Investigative Site

Skillman, New Jersey, 08558, United States

Location

Novartis Investigative Site

Raleigh, North Carolina, 27607, United States

Location

Novartis Investigative Site

Medford, Oregon, 97504, United States

Location

Novartis Investigative Site

El Paso, Texas, 79903, United States

Location

Novartis Investigative Site

Erpent, 5100, Belgium

Location

Novartis Investigative Site

Hasselt, 3500, Belgium

Location

Novartis Investigative Site

Mechelen, 2800, Belgium

Location

Novartis Investigative Site

Berlin, 10119, Germany

Location

Novartis Investigative Site

Frankfurt, 60596, Germany

Location

Novartis Investigative Site

Großhansdorf, 22927, Germany

Location

Novartis Investigative Site

Lübeck, 23552, Germany

Location

Novartis Investigative Site

Wiesbaden, 65187, Germany

Location

Novartis Investigative Site

Shinjuku-ku, Tokyo, 169-0073, Japan

Location

Novartis Investigative Site

Toshima-ku, Tokyo, 171-0014, Japan

Location

Novartis Investigative Site

Daugavpils, LVA, LV-5417, Latvia

Location

Novartis Investigative Site

Riga, LV 1002, Latvia

Location

Novartis Investigative Site

Riga, LV-1038, Latvia

Location

Novartis Investigative Site

Klaipėda, LT-92231, Lithuania

Location

Novartis Investigative Site

Klaipėda, LT-92288, Lithuania

Location

MeSH Terms

Conditions

Asthma; Dyspnea

Interventions

Glycopyrrolate

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

862-778-8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: May 3, 2017
• Study Start: May 4, 2017
• Primary Completion: December 29, 2017
• Study Completion: December 29, 2017
• Last Updated: January 16, 2019
• Results First Posted: January 16, 2019

Record last verified: 2019-01

Locations

JP (2); US (6); DE (5); LA (3); LI (2); BE (3)