Asthma MedDRA version: 14.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Code: QAB149 (PulmoSphere Formulation)
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Indacaterol maleate
CAS Number: 753498-25-8
Current Sponsor code: QAB149
Other
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female patients with asthma, aged 18 or above, diagnosed according to GINA guidelines (National Institute of Health, National Heart, Lung and Blood Institute, 2010) and who additionally meet the following criteria: • Patients receiving daily treatment with inhaled corticosteroid up to the maximum dose per day indicated in the package leaflet, in a stable regimen for at least 4 weeks prior to screening. • Patients with an FEV1 at screening and initial baseline of =50% of the predicted normal value for the patient. This criterion for FEV1 will have to be demonstrated after a washout period of at least 6 hours during which no short acting ß2-agonist has been inhaled, and a minimum washout of 48 hours for a long acting ß2-agonist or 7 days for tiotropium/indacaterol. If appropriate washout has not been achieved when the patient attends for screening the Screening Part 1 assessments should be completed and the patient should return for Screening Part 2. • Patients who demonstrate an increase of =12% and =200 mL in FEV1 over their prebronchodilator value after inhaling a total of 400 µg of salbutamol (the reversibility test) as per ATS/ERS Task force: Standardisation of Lung Function Testing guidelines. Reversibility will have to be demonstrated after an appropriate washout period as described in Section 3.1. The administration of salbutamol for the reversibility test is to be within 30 minutes after pre bronchodilator spirometry. If the patient does not show reversibility this may be repeated once. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 36 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients who require the use of = 12 puffs/24 hours of rescue medication for 48 hours between screening and randomization. • Patients who have a decline in PEFR from the reference PEFR (taken at screening) of =30% for 5 of the 6 consecutive scheduled PEFR readings (includes readings taken at morning and evening) between screening and randomization. • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use effective contraception during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the bronchodilator effect of once-daily indacaterol as a PulmoSphereTM formulation and lactose-blended indacaterol in adult patients with persistent asthma compared with placebo as measured by trough FEV1 after 7-days treatment.;Secondary Objective: To assess the bronchodilator effect of once-daily indacaterol pulmosphere formulation/lactose blend in patients with asthma compared with placebo as measured by other measures of lung function • To assess rescue medication use (Short acting beta agonists (SABA)) over the course of the treatment. • To assess the safety and tolerability of once-daily indacaterol pulmpsphere/lactose blend in comparison to placebo in terms of the number and percentage of adverse events, laboratory analysis, vital signs (blood pressure and pulse rate) and ECGs over the course of the treatment. • To assess the pharmacokinetics of indacaterol following a single dose and after 7 days repeated dosing;Primary end point(s): Assessment of the bronchodilator effect of once-daily indacaterol as a PulmoSphere formulation and lactose-blended indacaterol in adult patients with persistent asthma compared with placebo as measured by trough FEV1.;Timepoint(s) of evaluation of this end point: After 7 days of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To assess the bronchodilator effect of once-daily indacaterol pulmosphere forumulation/lactose belnd in patients with asthma compared with placebo as measured by: • Peak and time to peak FEV1 • FEV1, Forced Vital Capacity (FVC), FEV1/FVC and forced expiratory flow 25–75% (FEF25-75) • Standardized FEV1 AUC between baseline (pre-dose) and 4 hr post-dose (AUC0-4h) and 12 hr post-dose (AUC0-12h) ;Timepoint(s) of evaluation of this end point: On day 1 and day 7 | — |
Countries
Germany, United Kingdom
Contacts
Public ContactMedical Information Services
Novartis Pharmaceuticals UK Ltd
Outcome results
None listed