--- title: Bronchodilator Effects and Safety of Glycopyrronium Bromide (25 ug and 50 ug o.d.) in Asthma nct_id: NCT03137784 overall_status: COMPLETED phase: PHASE2, PHASE3 sponsor: Novartis Pharmaceuticals study_type: INTERVENTIONAL primary_condition: Asthma countries: United States, Belgium, Germany, Japan, Latvia, Lithuania canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03137784.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03137784" ct_last_update_post_date: 2019-01-16 last_seen_at: "2026-05-12T07:29:06.484Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # 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. **NCT ID:** [NCT03137784](https://clinicaltrials.gov/study/NCT03137784) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE2, PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 148 - **Lead Sponsor:** Novartis Pharmaceuticals - **Conditions:** Asthma - **Start Date:** 2017-05-04 - **Completion Date:** 2017-12-29 - **CT.gov Last Update:** 2019-01-16 ## 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will be followed by a 21-day Run-in epoch during which patients will continue their inhaled corticosteroids use but be withdrawn from LABA-treatment and switched to short-acting bronchodilator-rescue medication.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 - **Minimum age:** 18 Years - **Maximum age:** 65 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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). ``` ## Arms - **1(NVA237 50 ug/NVA237 25 ug/placebo)** (OTHER) — Treatment sequence: NVA 237 50 ug, 25 ug and placebo - **2(NVA237 50 ug/placebo/NVA237 25 ug)** (OTHER) — Treatment sequence: NVA 237 50 ug, placebo and 25 ug - **3 (NVA237 25 ug/NVA237 50 ug/placebo)** (OTHER) — Treatment sequence: NVA237 25 ug, 50 ug and placebo - **4 (NVA237 25 ug/placebo/NVA237 50 ug)** (OTHER) — Treatment sequence: NVA 237 25 ug, placebo and 50 ug - **5 (placebo/NVA237 50 ug/ NVA237 25 ug)** (OTHER) — Treatment sequence: Placebo, NVA237 50 ug and 25 ug - **6 (placebo/ NVA237 25 ug/NVA237 50 ug)** (OTHER) — Treatment sequence: placebo, NVA237 25 ug and 50 ug ## Interventions - **NVA237 (glycopyrronium bromide)** (DRUG) — In each treatment arm, patient will receive NVA237 (glycopyrronium bromide) 25 ug and 50 ug dose - **Placebo** (DRUG) — In each treatment arm, patient will receive placebo ## Primary Outcomes - **Trough FEV1 After One Week of Treatment, Point Estimate** _(time frame: Following 1 week of treatment)_ — 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. ## Secondary Outcomes - **FEV1 AUC (5 Min-1 h) After One Week of Treatment** _(time frame: Following 1 week of treatment)_ - **FEV1 AUC (5 Min-4 h) After One Week of Treatment** _(time frame: Following 1 week of treatment)_ - **FEV1 AUC (5 Min - 23 h 45 Min) After One Week of Treatment** _(time frame: Following 1 week of treatment)_ - **Peak FEV1 During 4 Hours Post-dose After 1 Week of Treatment** _(time frame: Following 1 week of treatment)_ - **Trough Forced Vital Capacity (FVC) After 1 Week of Treatment** _(time frame: Following 1 week of treatment)_ - **Percent Change From Baseline in FEV1/FVC Ratio** _(time frame: Following 1 week of treatment)_ - **Mean Morning Peak Expiratory Flow (PEF) Following the 1-week Treatment Period** _(time frame: Following 1 week of treatment)_ - **Mean Evening Peak Expiratory Flow Rate (PEF) Following 1-week Treatment** _(time frame: Following 1 week of treatment)_ - **Mean Daily Number of Puffs of Rescue Medication During 1 Week of Treatment** _(time frame: Following 1 week of treatment)_ ## Locations (21) - 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 ## Recent Field Changes (last 30 days) - `locations.novartis investigative site|shinjuku-ku|tokyo|japan` — added _(2026-05-12)_ - `locations.novartis investigative site|toshima-ku|tokyo|japan` — added _(2026-05-12)_ - `locations.novartis investigative site|mechelen||belgium` — added _(2026-05-12)_ - `locations.novartis investigative site|berlin||germany` — added _(2026-05-12)_ - `locations.novartis investigative site|frankfurt||germany` — added _(2026-05-12)_ - `locations.novartis investigative site|großhansdorf||germany` — added _(2026-05-12)_ - `locations.novartis investigative site|lübeck||germany` — added _(2026-05-12)_ - `locations.novartis investigative site|wiesbaden||germany` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.novartis investigative site|north dartmouth|massachusetts|united states` — added _(2026-05-12)_ - `locations.novartis investigative site|st louis|missouri|united states` — added _(2026-05-12)_ - `locations.novartis investigative site|skillman|new jersey|united states` — added _(2026-05-12)_ - `locations.novartis investigative site|raleigh|north carolina|united states` — added _(2026-05-12)_ - `locations.novartis investigative site|medford|oregon|united states` — added _(2026-05-12)_ - `locations.novartis investigative site|el paso|texas|united states` — added _(2026-05-12)_ - `locations.novartis investigative site|erpent||belgium` — added _(2026-05-12)_ - `locations.novartis investigative site|hasselt||belgium` — added _(2026-05-12)_ - `locations.novartis investigative site|daugavpils|lva|latvia` — added _(2026-05-12)_ - `locations.novartis investigative site|riga||latvia` — added _(2026-05-12)_ - `locations.novartis investigative site|klaipėda||lithuania` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT03137784.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT03137784* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*