Study of Efficacy and Safety of NVA237 in Patients With Poorly Controlled Asthma

NCT ID: NCT02127697

Last Updated: 2015-04-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2017-05-31

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

NVA237

Intervention Type: DRUG

NVA237 capsules for inhalation, delivered via Concept1 once daily

salbutamol/ albuterol

Intervention Type: DRUG

Taken as rescue medication

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.

Group Type: PLACEBO_COMPARATOR

Placebo to NVA237

Intervention Type: DRUG

Placebo to NVA237 delivered via Concept1 once daily

salbutamol/ albuterol

Intervention Type: DRUG

Taken as rescue medication

Interventions

NVA237

NVA237 capsules for inhalation, delivered via Concept1 once daily

Intervention Type: DRUG

Placebo to NVA237

Placebo to NVA237 delivered via Concept1 once daily

Intervention Type: DRUG

salbutamol/ albuterol

Taken as rescue medication

Intervention Type: DRUG

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Other Identifiers

CNVA237B2301

Identifier Type: -

Identifier Source: org_study_id