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临床试验/NCT03137784
NCT03137784已完成2 期

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.

Novartis Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2017年5月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
148
试验地点
1
主要终点
Trough FEV1 After One Week of Treatment, Point Estimate

研究概览

简要总结

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

详细描述

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will be followed by a 21-day Run-in epoch during which patients will continue their inhaled corticosteroids use but be withdrawn from LABA-treatment and switched to short-acting bronchodilator-rescue medication.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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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).

研究组 & 干预措施

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

Other

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

干预措施: NVA237 (glycopyrronium bromide) (Drug)

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

Other

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

干预措施: Placebo (Drug)

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

Other

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

干预措施: NVA237 (glycopyrronium bromide) (Drug)

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

Other

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

干预措施: Placebo (Drug)

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

Other

Treatment sequence: NVA237 25 ug, 50 ug and placebo

干预措施: NVA237 (glycopyrronium bromide) (Drug)

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

Other

Treatment sequence: NVA237 25 ug, 50 ug and placebo

干预措施: Placebo (Drug)

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

Other

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

干预措施: NVA237 (glycopyrronium bromide) (Drug)

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

Other

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

干预措施: Placebo (Drug)

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

Other

Treatment sequence: Placebo, NVA237 50 ug and 25 ug

干预措施: NVA237 (glycopyrronium bromide) (Drug)

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

Other

Treatment sequence: Placebo, NVA237 50 ug and 25 ug

干预措施: Placebo (Drug)

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

Other

Treatment sequence: placebo, NVA237 25 ug and 50 ug

干预措施: NVA237 (glycopyrronium bromide) (Drug)

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

Other

Treatment sequence: placebo, NVA237 25 ug and 50 ug

干预措施: Placebo (Drug)

结局指标

主要结局

Trough FEV1 After One Week of Treatment, Point Estimate

时间窗: 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.

次要结局

  • FEV1 AUC (5 Min-4 h) After One Week of Treatment(Following 1 week of treatment)
  • Mean Morning Peak Expiratory Flow (PEF) Following the 1-week Treatment Period(Following 1 week of treatment)
  • FEV1 AUC (5 Min-1 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)
  • Mean Evening Peak Expiratory Flow Rate (PEF) Following 1-week Treatment(Following 1 week of treatment)
  • Peak FEV1 During 4 Hours Post-dose After 1 Week of Treatment(Following 1 week of treatment)
  • Mean Daily Number of Puffs of Rescue Medication During 1 Week of Treatment(Following 1 week of treatment)
  • Percent Change From Baseline in FEV1/FVC Ratio(Following 1 week of treatment)
  • Trough Forced Vital Capacity (FVC) After 1 Week of Treatment(Following 1 week of treatment)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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