Clinical trial NCT01484197: A Study to Evaluate the Effects of Indacaterol Maleate as a New Formulation in the Concept 1 Device
Official title: A Multi-centre, Randomized, Double-blind, Double-dummy, Multiple-dose, Crossover Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Orally Inhaled Indacaterol Administered as Either PulmoSphere or Lactose-blend Powder Via the Concept1 Device in Adult Patients With Persistent Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma
Indacaterol
QAB149
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-12-02
Enrollment: 36
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 two different formulations of indacaterol maleate, both administered via the Concept1 device. The study aims to determine whether the novel formulation has a similar clinical profile as the established formulation.


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

Primary outcomes:
measure: Trough Forced Expiratory Volume in One Second (FEV1) After 7 Days of Treatment
timeFrame: Day 8
Secondary outcomes:
measure: Trough Forced Expiratory Volume in One Second (FEV1) After 1 Day of Treatment
timeFrame: Day 2
measure: Peak FEV1 at Day 1 and Day 7
timeFrame: Day 1, Day 7
measure: Time to Peak FEV1 at Day 1 and Day 7
timeFrame: Day 1, Day 7
measure: FEV1 at Each Time-Point on Day 1 and Day 2
timeFrame: Day 1, Day 2
measure: FEV1 at Each Time-Point on Day 7 and Day 8
timeFrame: Day 7, Day 8
measure: Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2
timeFrame: Day 1, Day 2
measure: Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8
timeFrame: Day 7, Day 8
measure: FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2
timeFrame: Day1, Day 2
measure: FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8
timeFrame: Day 7, Day 8
measure: Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2
timeFrame: Day 1, Day 2
measure: Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8
timeFrame: Day 7, Day 8
measure: Standardized FEV1 AUC Between Baseline (Pre-dose) and 4 Hour Post-dose (AUC0-4h)
timeFrame: Day 1, Day 7
measure: Standardized FEV1 AUC Between Baseline (Pre-dose) and 12 Hour Post-dose (AUC0-12h)
timeFrame: Day 1, Day 7
measure: Peak Expiratory Flow Rate in the Morning in the Evening
timeFrame: Up to 101 days
measure: Number of Puffs of Rescue Medicine
timeFrame: Up to 101 days
measure: Number of Participants With Adverse Events as a Measure of Safety
timeFrame: Up to 101 days
measure: Time to Reach Maximum Concentration (Tmax) After Drug Administration
timeFrame: Day1, Day 7
measure: Observed Maximum Concentration (Cmax) After Drug Administration
timeFrame: Day 1, Day 7
measure: Area Under the Curve Pre-dose to 24 Hour Post Dose (AUC0-24h)
timeFrame: Day 1, Day 7
Other outcomes:
Locations:
city: Wiesbaden
country: Germany
facility: Novartis Investigative Site
city: Machester
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: