A Study to Evaluate the Effects of Indacaterol Maleate (QAB149) as a New Formulation in the EPIC Test Fixture
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
2 other identifiers
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2013
Shorter than P25 for phase_2 asthma
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2013
CompletedFirst Posted
Study publicly available on registry
May 3, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedApril 20, 2017
July 1, 2013
4 months
April 17, 2013
April 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Trough Forced Expiratory Volume in 1 Second (FEV1) Following 3 Days of Treatment
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The trough in FEV1 was defined as the mean of two measurements at 23h 10min and 23h 45min post the Day 3 dose.
Day 4
Secondary Outcomes (15)
Peak Forced Expiratory Volume in 1 Second (FEV1) on Days 1 and 3
Days 1 and 3
Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Days 1 and 3
Days 1 and 3
Forced Vital Capacity (FVC) at Each Time-point on Day 1, 2, 3 and 4
Days 1, 2, 3 and 4
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
Days 1 and 3
Peak Expiratory Flow Rate measured daily each morning and evening.
Morning and evening from screening to study completion (up to 86 days)
- +10 more secondary outcomes
Study Arms (3)
Treatment A
EXPERIMENTALTreatment B
EXPERIMENTALTreatment C
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Asthma exacerbations in previous 6 months COPD or other pulmonary disease Excessive use of short acting beta agonists
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2013
First Posted
May 3, 2013
Study Start
August 1, 2013
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
April 20, 2017
Record last verified: 2013-07