Clinical trial NCT03137784: Bronchodilator Effects and Safety of Glycopyrronium Bromide (25 ug and 50 ug o.d.) in Asthma
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled 3-period Complete Cross-over Study to Assess the Bronchodilator Effects and Safety of Glycopyrronium Bromide (NVA237) (25 ug and 50 ug o.d.) in Asthma Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Asthma
Keywords: asthma,
NVA237,
glycopyrronium bromide
allergic asthma,
allergy triggered asthma,
reactive asthma,
asthma attack,
difficulty breathing
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2017-05-03
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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will be followed by a 21-day Run-in epoch during which patients will continue their inhaled corticosteroids use but be withdrawn from LABA-treatment and switched to short-acting bronchodilator-rescue medication.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.

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

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).

Primary outcomes:
measure: Trough FEV1 After One Week of Treatment, Point Estimate
timeFrame: Following 1 week of treatment
Secondary outcomes:
measure: FEV1 AUC (5 Min-1 h) After One Week of Treatment
timeFrame: Following 1 week of treatment
measure: FEV1 AUC (5 Min-4 h) After One Week of Treatment
timeFrame: Following 1 week of treatment
measure: FEV1 AUC (5 Min - 23 h 45 Min) After One Week of Treatment
timeFrame: Following 1 week of treatment
measure: Peak FEV1 During 4 Hours Post-dose After 1 Week of Treatment
timeFrame: Following 1 week of treatment
measure: Trough Forced Vital Capacity (FVC) After 1 Week of Treatment
timeFrame: Following 1 week of treatment
measure: Percent Change From Baseline in FEV1/FVC Ratio
timeFrame: Following 1 week of treatment
measure: Mean Morning Peak Expiratory Flow (PEF) Following the 1-week Treatment Period
timeFrame: Following 1 week of treatment
measure: Mean Evening Peak Expiratory Flow Rate (PEF) Following 1-week Treatment
timeFrame: Following 1 week of treatment
measure: Mean Daily Number of Puffs of Rescue Medication During 1 Week of Treatment
timeFrame: Following 1 week of treatment
Other outcomes:
Locations:
city: North Dartmouth
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Saint Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Skillman
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Raleigh
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Medford
country: United States
facility: Novartis Investigative Site
state: Oregon
city: El Paso
country: United States
facility: Novartis Investigative Site
state: Texas
city: Erpent
country: Belgium
facility: Novartis Investigative Site
city: Hasselt
country: Belgium
facility: Novartis Investigative Site
city: Mechelen
country: Belgium
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Grosshansdorf
country: Germany
facility: Novartis Investigative Site
city: Lubeck
country: Germany
facility: Novartis Investigative Site
city: Wiesbaden
country: Germany
facility: Novartis Investigative Site
city: Shinjuku-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Toshima-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Daugavpils
country: Latvia
facility: Novartis Investigative Site
state: LVA
city: Riga
country: Latvia
facility: Novartis Investigative Site
city: Riga
country: Latvia
facility: Novartis Investigative Site
city: Klaipeda
country: Lithuania
facility: Novartis Investigative Site
city: Klaipeda
country: Lithuania
facility: Novartis Investigative Site
Study officials:
References: