A Study to Evaluate the Effects of Indacaterol Maleate as a New Formulation in the Concept 1 Device
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
2 other identifiers
interventional
36
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 asthma
Started Nov 2011
Shorter than P25 for phase_2 asthma
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 15, 2011
CompletedFirst Posted
Study publicly available on registry
December 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedResults Posted
Study results publicly available
December 6, 2013
CompletedApril 1, 2015
March 1, 2015
6 months
November 15, 2011
May 17, 2013
March 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Trough Forced Expiratory Volume in One Second (FEV1) After 7 Days of Treatment
Spirometry was performed according to internationally accepted standards at Day 8. Trough FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Trough FEV1 was defined as the average of the FEV1 measurements at 23 hours 10 minutes and 23 hours 45 minutes post dose.at Day 8. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate.
Day 8
Secondary Outcomes (19)
Trough Forced Expiratory Volume in One Second (FEV1) After 1 Day of Treatment
Day 2
Peak FEV1 at Day 1 and Day 7
Day 1, Day 7
Time to Peak FEV1 at Day 1 and Day 7
Day 1, Day 7
FEV1 at Each Time-Point on Day 1 and Day 2
Day 1, Day 2
FEV1 at Each Time-Point on Day 7 and Day 8
Day 7, Day 8
- +14 more secondary outcomes
Study Arms (4)
75 µg Indacaterol (LB) + Placebo (PoS)
EXPERIMENTAL75 µg indacaterol maleate lactose blend (LB) + placebo to indacterol PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.
75 µg Indacaterol (PoS) + Placebo (LB)
EXPERIMENTAL75 µg indacaterol maleate PulmoSphereTM (PoS) + placebo to indacterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
37.5 µg Indacaterol (PoS) + Placebo (LB)
EXPERIMENTAL37.5 µg indacaterol maleate PulmoSphereTM (PoS) + placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
Placebo (LB) and Placebo (PoS)
EXPERIMENTALPlacebo to indacaterol PulmoSphereTM (PoS) + placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
Interventions
75 µg indacaterol maleate lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
75 µg indacaterol maleate PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.
37.5 µg indacaterol maleate PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.
Placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
Placebo to indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.
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
Study Sites (2)
Novartis Investigative Site
Wiesbaden, Germany, 65187, Germany
Novartis Investigative Site
Machester, M23 9QZ, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2011
First Posted
December 2, 2011
Study Start
November 1, 2011
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
April 1, 2015
Results First Posted
December 6, 2013
Record last verified: 2015-03