Clinical trial NCT01845623: A Study to Evaluate the Effects of Indacaterol Maleate (QAB149) as a New Formulation in the EPIC Test Fixture
Official title: A Randomized, Double-blind, Double-dummy, Placebo-controlled, 3-period Crossover Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Orally Inhaled Indacaterol Administered Via the EPIC Test Fixture and the Concept1 Device in Adult Patients With Persistent Asthma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma
Indacaterol
QAB149
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-05-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will assess the pharmacodynamics, safety, tolerability and pharmacokinetics of indacaterol maleate (QAB149), administered via the EPIC test fixture. The study aims to determine whether the novel device has a similar clinical profile as the established concept 1 device.


Eligibility criteria: Inclusion Criteria:

Male and female patients with asthma, aged 18 or above Patients using inhaled corticosteroid (with or without long acting beta agonist) Patients who demonstrate an increase in FEV1 after inhaling a short acting beta agonist

Exclusion Criteria:

Asthma exacerbations in previous 6 months COPD or other pulmonary disease Excessive use of short acting beta agonists

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Trough Forced Expiratory Volume in 1 Second (FEV1) Following 3 Days of Treatment
timeFrame: Day 4
Secondary outcomes:
measure: Peak Forced Expiratory Volume in 1 Second (FEV1) on Days 1 and 3
timeFrame: Days 1 and 3
measure: Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Days 1 and 3
timeFrame: Days 1 and 3
measure: Forced Vital Capacity (FVC) at Each Time-point on Day 1, 2, 3 and 4
timeFrame: Days 1, 2, 3 and 4
measure: Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From pre-dose to 4 hours post dose on Days 1 and 3
timeFrame: Days 1 and 3
measure: Peak Expiratory Flow Rate measured daily each morning and evening.
timeFrame: Morning and evening from screening to study completion (up to 86 days)
measure: Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Days 1, 2, 3 and 4
measure: Ratio of Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) (FEV1/FVC
timeFrame: Days 1, 2, 3, 4
measure: Forced expiratory Flow 25-75% (FEF25-75%)
timeFrame: Days 1, 2, 3, 4
measure: Number of puffs of rescue medication used
timeFrame: Everyday from screening to study completion (up to 86 days)
measure: The number of participants with adverse events used as a measure of Safety and Tolerability
timeFrame: Baseline to study completion (up to 59 days)
measure: AUC (0-24) - area under the serum concentration-time curve
timeFrame: Day 1 and Day 3 (pre-dose, 5, 15, 30 mins, 1, 2, 4, 8, 12, 24hours post dose
measure: Cmax - observed maximum serum concentration following drug administration
timeFrame: Day 1 and Day 3 (pre-dose, 5, 15, 30 mins, 1, 2, 4, 8, 12, 24hours post dose
measure: Tmax - time to reach maximum concentration after drug administration
timeFrame: Day 1 and Day 3 (pre-dose, 5, 15, 30 mins, 1, 2, 4, 8, 12, 24hours post dose
measure: Racc - accumulation ratio of exposure (AUC0-24 and Cmax) on Day 3 relative to Day 1
timeFrame: Day 1 and Day 3 (pre-dose, 5, 15, 30 mins, 1, 2, 4, 8, 12, 24hours post dose
measure: Trough Forced Expiratory Volume in 1 Second (FEV1) Following 1 Day of Treatment
timeFrame: Day 2
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: