NCT02127697
Withdrawn
Phase 3
A Randomized, Double-blind, Parallel Group, 52-week Study Evaluating the Efficacy, Safety and Tolerability of NVA237 in Patients With Poorly Controlled Asthma
ConditionsAsthma
Overview
- Phase
- Phase 3
- Intervention
- NVA237
- Conditions
- Asthma
- Sponsor
- Novartis Pharmaceuticals
- Primary Endpoint
- Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 26
- Status
- Withdrawn
- Last Updated
- 11 years ago
Overview
Brief Summary
The study will assess efficacy, safety and tolerability of NVA237 compared to placebo in patients with poorly controlled asthma over 52 weeks of treatment.
Detailed Description
The study will assess efficacy and safety of NVA237 compared to placebo, in addition to background therapy with LABA/ICS in patients with poorly controlled asthma.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Written informed consent must be obtained before any assessment is performed; Male and female adult patients aged 18 to \<75 years; Patients with a diagnosis of asthma (according to GINA 2012) for a period of at least 5 years prior screening; The diagnosis of asthma must have been made before the patient was 40; Increase in forced expiratory volume in 1 second (FEV1) of ≥ 12% and ≥ 200 mLs within 30 minutes after administration of 400 µg salbutamol/360 µg albuterol (or equivalent dose); Pre-bronchodilator FEV1 of ≥ 50 and ≤ 80% of the predicted normal value for the patient; Patients who qualify for treatment (according to GINA 2012) and have been treated with a stable dose of a fixed dose inhaled corticosteriod (ICS) and long-acting β2 agonist (LABA) combination for at least 4 weeks prior to screening. Patient must be using a total daily dose of ICS of ≥800 μg/day of budesonide of equivalent; All patients must be symptomatic with a mean ACQ-5 score ≥ 1.5 at Visit 101 and Visit 102; A documented history of one or more asthma exacerbations in the previous 12 months that required either treatment with additional or increased dose of systemic corticosteroids for at least 3 days, or an emergency room visit, or hospital treatment, or intubation
Exclusion Criteria
- •Contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs, drugs of a similar class, or any component thereof:
- •Muscarinic antagonist agents, sympathomimetic amines, lactose or any of the other excipients of the study drug, long and short acting beta-2 agonists, corticosteroids; Women of child-bearing potential; Resting QTcF ≥ 450 ms (male) or ≥ 460 ms (female) at Visit 101 (assessed by central reader) and at Visit 102 (assessed by investigator at the site); Patients with a body mass index (BMI) of more than 40 kg/m2; Patients who have clinically significant renal, cardiovascular (such as but not limited to unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, myocardial infarction, arrhythmia, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which could interfere with the assessment of the efficacy and safety of the study treatment; Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention (BPH patients who are stable on treatment can be considered); Patients who have had an asthma exacerbation that required either treatment with additional or increased dose of systemic corticosteroids for at least 3 days, or an emergency room visit, or hospital treatment, or intubation in the 6 weeks prior to screening; Patients who have smoked or inhaled tobacco products within the 6 month period prior to screening, or who have a smoking history of greater than 10 pack years (Note:10 pack years = 1 pack /day x 10 yrs., or ½ pack/day x 20 yrs.); 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 must have been so for at least 3 months prior to run-in, and must be expected to remain unchanged throughout the course of the study;
Arms & Interventions
NVA237
Participants will receive NVA237 once daily in addition to their background therapy during the 52- week treatment period. All participants will receive salbutamol/ albuterol as rescue medication.
Intervention: NVA237
NVA237
Participants will receive NVA237 once daily in addition to their background therapy during the 52- week treatment period. All participants will receive salbutamol/ albuterol as rescue medication.
Intervention: salbutamol/ albuterol
Placebo
Participants will receive placebo to NVA237 in addition to their background therapy during the 52-week treatment period. All participants will receive salbutamol/ albuterol as rescue medication.
Intervention: Placebo to NVA237
Placebo
Participants will receive placebo to NVA237 in addition to their background therapy during the 52-week treatment period. All participants will receive salbutamol/ albuterol as rescue medication.
Intervention: salbutamol/ albuterol
Outcomes
Primary Outcomes
Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 26
Time Frame: Week 26
Spirometry testing will be performed in accordance with American Thoracic Society standards. Trough FEV1 defined as the mean of two measurements at 23 hours 15 minutes and 23 hour 45 minutes post dosing.
Secondary Outcomes
- Peak Forced Expiratory Volume in 1 Second (FEV1) Over 52 Weeks of Treatment(Day 1, Week 4, Week 26, Week 52)
- Rate of Moderate or Severe Asthma Exacerbation(52 Weeks)
- Quality of Life Assessment With St. George's Respiratory Questionnaire (SGRQ) Over 52-Week Treatment Period(Week 12, Week 26, Week 52)
- Shortened Version of the Asthma Control Questionnaire (ACQ-5)(Week 4, Week 8, Week 12, Week 26, Week 39, Week 52)
- Time to First Moderate or Severe Asthma Exacerbation Over 52 Weeks of Treatment(52 weeks)
- Quality of Life as Assessed by Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) Over 52-Week Treatment Period.(Week 12, Week 26, Week 52)
- Trough Forced Expiratory Volume in 1 Second (FEV1) Over 52 Weeks of Treatment(Day 2, Week 4, Week 26, Week 52)
- Time To First Severe Asthma Exacerbation(52 Weeks)
- Evening Daily Peak Expiratory Flow (PEF) Over 52 Weeks of Treatment(Every 3 Months, 52 Weeks)
- Forced Vital Capacity (FVC)(Week 2, Week 4, Week 8, Week 12, Week 26, Week 39, Week 52)
- Rate of Asthma Exacerbation (Mild, Moderate, or Severe)(52 Weeks)
- Asthma Control Diary (ACD) Symptom Score Over 52-Week Treatment Period(Every 3 Months, 52 Weeks)
- Asthma Control Questionnaire (ACQ-7) Overall Score at Week 26(Week 26)
- Shortened Version of the Asthma Control Questionnaire (ACQ-6)(Week 4, Week 8, Week 12, Week 26, Week 39, Week 52)
- Rate of Severe Asthma Exacerbation(52 Weeks)
- Morning Daily Peak Expiratory Flow (PEF) Over 52 Weeks of Treatment(Every 3 Months, 52 Weeks)
- Asthma Control Questionnaire (ACQ-7) Over 52 Weeks of Treatment(Week 4, Week 8, Week 12, Week 26, Week 39, Week 52)
- Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC0-3h) Over 52 Weeks of Treatment(Day 1, Week 4, Week 26, Week 52)
- Predose Forced Expiratory Volume in 1 Second (FEV1) Over 52 Weeks of Treatment(Week 2, Week 4, Week 8, Week 26, Week 39, Week 52)
- Mean Daily Number of Puffs of Rescue Medication Over 52 Weeks of Treatment(52 Weeks)
- Lung Function Assessed by Forced Expiratory Volume for 1 Second (FEV1)(Week 1, Week 2, Week 4, Week 8, Week 12, Week 26, Week 39, Week 52)
- Time To First Asthma Exacerbation (Mild, Moderate, or Severe)(52 Weeks)
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