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

• Register: ClinicalTrials.gov
• Last refreshed on: 20 April 2015
• Main ID: NCT02127697
• Date of registration: 29/04/2014
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Study of Efficacy and Safety of NVA237 in Patients With Poorly Controlled Asthma
• Scientific title: A Randomized, Double-blind, Parallel Group, 52-week Study Evaluating the Efficacy, Safety and Tolerability of NVA237 in Patients With Poorly Controlled Asthma
• Date of first enrolment: March 2015
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT02127697
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Belgium, Brazil, Bulgaria, Canada, Croatia, Estonia, Germany, Hungary, India, Italy, Latvia, Lithuania, Netherlands, Romania, Slovakia, Slovenia, South Africa, Spain, Turkey, United States, Vietnam

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion 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 ß2 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;



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Asthma

Intervention(s)

Drug: NVA237

Drug: Placebo to NVA237

Drug: salbutamol/ albuterol

Primary Outcome(s)

Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 26 [Time Frame: Week 26]

Secondary Outcome(s)

Quality of Life as Assessed by Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) Over 52-Week Treatment Period. [Time Frame: Week 12, Week 26, Week 52]

Asthma Control Questionnaire (ACQ-7) Overall Score at Week 26 [Time Frame: Week 26]

Rate of Moderate or Severe Asthma Exacerbation [Time Frame: 52 Weeks]

Shortened Version of the Asthma Control Questionnaire (ACQ-5) [Time Frame: 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 [Time Frame: Day 1, Week 4, Week 26, Week 52]

Forced Vital Capacity (FVC) [Time Frame: Week 2, Week 4, Week 8, Week 12, Week 26, Week 39, Week 52]

Trough Forced Expiratory Volume in 1 Second (FEV1) Over 52 Weeks of Treatment [Time Frame: Day 2, Week 4, Week 26, Week 52]

Morning Daily Peak Expiratory Flow (PEF) Over 52 Weeks of Treatment [Time Frame: Every 3 Months, 52 Weeks]

Predose Forced Expiratory Volume in 1 Second (FEV1) Over 52 Weeks of Treatment [Time Frame: Week 2, Week 4, Week 8, Week 26, Week 39, Week 52]

Rate of Asthma Exacerbation (Mild, Moderate, or Severe) [Time Frame: 52 Weeks]

Rate of Severe Asthma Exacerbation [Time Frame: 52 Weeks]

Lung Function Assessed by Forced Expiratory Volume for 1 Second (FEV1) [Time Frame: Week 1, Week 2, 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 [Time Frame: 52 weeks]

Evening Daily Peak Expiratory Flow (PEF) Over 52 Weeks of Treatment [Time Frame: Every 3 Months, 52 Weeks]

Shortened Version of the Asthma Control Questionnaire (ACQ-6) [Time Frame: Week 4, Week 8, Week 12, Week 26, Week 39, Week 52]

Mean Daily Number of Puffs of Rescue Medication Over 52 Weeks of Treatment [Time Frame: 52 Weeks]

Asthma Control Diary (ACD) Symptom Score Over 52-Week Treatment Period [Time Frame: Every 3 Months, 52 Weeks]

Peak Forced Expiratory Volume in 1 Second (FEV1) Over 52 Weeks of Treatment [Time Frame: Day 1, Week 4, Week 26, Week 52]

Asthma Control Questionnaire (ACQ-7) Over 52 Weeks of Treatment [Time Frame: Week 4, Week 8, Week 12, Week 26, Week 39, Week 52]

Time To First Asthma Exacerbation (Mild, Moderate, or Severe) [Time Frame: 52 Weeks]

Time To First Severe Asthma Exacerbation [Time Frame: 52 Weeks]

Quality of Life Assessment With St. George's Respiratory Questionnaire (SGRQ) Over 52-Week Treatment Period [Time Frame: Week 12, Week 26, Week 52]

Secondary ID(s)

CNVA237B2301

Source(s) of Monetary Support

Please refer to primary and secondary sponsors