Back to resultsA Study to Evaluate the Effects of Indacaterol Maleate (QAB149) as a New Formulation in the EPIC Test Fixture
Primary Purpose
Asthma
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
QAB149 75 mg Concept 1
QAB149 75 mg Epic Test Fixture
Placebo Concept 1
Placebo EPIC Test Fixture
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Asthma, Indacaterol, QAB149
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Treatment A
Treatment B
Treatment C
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Peak Forced Expiratory Volume in 1 Second (FEV1) on Days 1 and 3
Spirometry was conducted according to internationally accepted standards. Peak FEV1 is the maximum FEV1 recorded in the period between 5 minutes and 4 hours post dose on Days 1 and 3.
Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Days 1 and 3
Spirometry was conducted according to internationally accepted standards. Peak FEV1 is the maximum FEV1 recorded in the period between 5 minutes and 4 hours post dose on Days 1 and 3.
Forced Vital Capacity (FVC) at Each Time-point on Day 1, 2, 3 and 4
Spirometry was conducted according to internationally accepted standards. FVC was calculated at each time point up to 4 hours post-dose and at 23 hours 10 min and 23 hours 45 min on Days 1/2 and 3/4.
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
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time.
Peak Expiratory Flow Rate measured daily each morning and evening.
Peak Expiratory Flow (PEF) was measured every morning and evening from screening until study completion using a peak flow meter, and was recorded in the patient diary.
Forced Expiratory Volume in 1 Second (FEV1)
Spirometry was conducted according to internationally accepted standards. Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 was measured at each time point up to 4 hours on Days 1 and 3 and at 23hours 10 mins and 23 hours 45 mins on Days 2 and 4.
Ratio of Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) (FEV1/FVC
Spirometry was conducted according to internationally accepted standards. FEV1/FVC represents the proportion of the total amount of air that is exhaled from the lungs during the first second of forced exhalation. FEV1/FVC was measured at each timepoint up to 4 hours on Days 1 and 3 and 23hours 10mins and 23hours 45 mins on Days 2 and 4.
Forced expiratory Flow 25-75% (FEF25-75%)
The forced expiratory flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry. FEF 25-75% was measured at each timepoint up to 4 hours on Days 1 and 3 and 23hours 10mins and 23hours 45 mins on Days 2 and 4
Number of puffs of rescue medication used
Participants maintained a diary to record the daily number of puffs of rescue Short-acting B2 agonist (SABA) used to treat asthma symptoms.
The number of participants with adverse events used as a measure of Safety and Tolerability
Safety and tolerability of indacaterol administered via the EPIC test fixture and the Concept1 was measured by collecting the following safety data: - number and percentage of adverse events reported by participants for the duration of the study - safety laboratory testing - measurement of vital signs (blood pressure and heart rate) - measurement of ECGs
AUC (0-24) - area under the serum concentration-time curve
The PK parameter AUC0-24 - area under the serum concentration-time curve - was determined from the serum concentration time profile of indacaterol on Days 1 and 3 from time zero to 24 hours post dose using a non-compartmental method
Cmax - observed maximum serum concentration following drug administration
The PK parameter Cmax - observed maximum serum concentration following drug administration - was determined from the serum concentration time profile of indacaterol on Days 1 and 3 using a non-compartmental method.
Tmax - time to reach maximum concentration after drug administration
The PK parameter Tmax - time to reach maximum concentration after drug administration - was determined from the serum concentration time profile of indacaterol on Days 1 and 3 using a non-compartmental method.
Racc - accumulation ratio of exposure (AUC0-24 and Cmax) on Day 3 relative to Day 1
The PK parameter Racc - accumulation ratio of exposure (AUC0-24 and Cmax) on Day 3 relative to Day 1 - was determined from the serum concentration time profile of indacaterol on Days 1 and 3 using a non-compartmental method.
Trough Forced Expiratory Volume in 1 Second (FEV1) Following 1 Day 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 1 dose.
Full Information
NCT ID
NCT01845623
First Posted
April 17, 2013
Last Updated
April 19, 2017
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01845623
Brief Title
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
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Withdrawn
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Indacaterol, QAB149
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment A
Arm Type
Experimental
Arm Title
Treatment B
Arm Type
Experimental
Arm Title
Treatment C
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
QAB149 75 mg Concept 1
Intervention Description
QAB149 delivered via the concept 1 device.
Intervention Type
Drug
Intervention Name(s)
QAB149 75 mg Epic Test Fixture
Intervention Description
QAB149 delivered via the EPIC test fixture
Intervention Type
Other
Intervention Name(s)
Placebo Concept 1
Intervention Description
Placebo administered via the Concept 1 device.
Intervention Type
Other
Intervention Name(s)
Placebo EPIC Test Fixture
Intervention Description
Placebo administered via the EPIC Test Fixture.
Primary Outcome Measure Information:
Title
Trough Forced Expiratory Volume in 1 Second (FEV1) Following 3 Days of Treatment
Description
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.
Time Frame
Day 4
Secondary Outcome Measure Information:
Title
Peak Forced Expiratory Volume in 1 Second (FEV1) on Days 1 and 3
Description
Spirometry was conducted according to internationally accepted standards. Peak FEV1 is the maximum FEV1 recorded in the period between 5 minutes and 4 hours post dose on Days 1 and 3.
Time Frame
Days 1 and 3
Title
Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Days 1 and 3
Description
Spirometry was conducted according to internationally accepted standards. Peak FEV1 is the maximum FEV1 recorded in the period between 5 minutes and 4 hours post dose on Days 1 and 3.
Time Frame
Days 1 and 3
Title
Forced Vital Capacity (FVC) at Each Time-point on Day 1, 2, 3 and 4
Description
Spirometry was conducted according to internationally accepted standards. FVC was calculated at each time point up to 4 hours post-dose and at 23 hours 10 min and 23 hours 45 min on Days 1/2 and 3/4.
Time Frame
Days 1, 2, 3 and 4
Title
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
Description
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time.
Time Frame
Days 1 and 3
Title
Peak Expiratory Flow Rate measured daily each morning and evening.
Description
Peak Expiratory Flow (PEF) was measured every morning and evening from screening until study completion using a peak flow meter, and was recorded in the patient diary.
Time Frame
Morning and evening from screening to study completion (up to 86 days)
Title
Forced Expiratory Volume in 1 Second (FEV1)
Description
Spirometry was conducted according to internationally accepted standards. Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 was measured at each time point up to 4 hours on Days 1 and 3 and at 23hours 10 mins and 23 hours 45 mins on Days 2 and 4.
Time Frame
Days 1, 2, 3 and 4
Title
Ratio of Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) (FEV1/FVC
Description
Spirometry was conducted according to internationally accepted standards. FEV1/FVC represents the proportion of the total amount of air that is exhaled from the lungs during the first second of forced exhalation. FEV1/FVC was measured at each timepoint up to 4 hours on Days 1 and 3 and 23hours 10mins and 23hours 45 mins on Days 2 and 4.
Time Frame
Days 1, 2, 3, 4
Title
Forced expiratory Flow 25-75% (FEF25-75%)
Description
The forced expiratory flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry. FEF 25-75% was measured at each timepoint up to 4 hours on Days 1 and 3 and 23hours 10mins and 23hours 45 mins on Days 2 and 4
Time Frame
Days 1, 2, 3, 4
Title
Number of puffs of rescue medication used
Description
Participants maintained a diary to record the daily number of puffs of rescue Short-acting B2 agonist (SABA) used to treat asthma symptoms.
Time Frame
Everyday from screening to study completion (up to 86 days)
Title
The number of participants with adverse events used as a measure of Safety and Tolerability
Description
Safety and tolerability of indacaterol administered via the EPIC test fixture and the Concept1 was measured by collecting the following safety data: - number and percentage of adverse events reported by participants for the duration of the study - safety laboratory testing - measurement of vital signs (blood pressure and heart rate) - measurement of ECGs
Time Frame
Baseline to study completion (up to 59 days)
Title
AUC (0-24) - area under the serum concentration-time curve
Description
The PK parameter AUC0-24 - area under the serum concentration-time curve - was determined from the serum concentration time profile of indacaterol on Days 1 and 3 from time zero to 24 hours post dose using a non-compartmental method
Time Frame
Day 1 and Day 3 (pre-dose, 5, 15, 30 mins, 1, 2, 4, 8, 12, 24hours post dose
Title
Cmax - observed maximum serum concentration following drug administration
Description
The PK parameter Cmax - observed maximum serum concentration following drug administration - was determined from the serum concentration time profile of indacaterol on Days 1 and 3 using a non-compartmental method.
Time Frame
Day 1 and Day 3 (pre-dose, 5, 15, 30 mins, 1, 2, 4, 8, 12, 24hours post dose
Title
Tmax - time to reach maximum concentration after drug administration
Description
The PK parameter Tmax - time to reach maximum concentration after drug administration - was determined from the serum concentration time profile of indacaterol on Days 1 and 3 using a non-compartmental method.
Time Frame
Day 1 and Day 3 (pre-dose, 5, 15, 30 mins, 1, 2, 4, 8, 12, 24hours post dose
Title
Racc - accumulation ratio of exposure (AUC0-24 and Cmax) on Day 3 relative to Day 1
Description
The PK parameter Racc - accumulation ratio of exposure (AUC0-24 and Cmax) on Day 3 relative to Day 1 - was determined from the serum concentration time profile of indacaterol on Days 1 and 3 using a non-compartmental method.
Time Frame
Day 1 and Day 3 (pre-dose, 5, 15, 30 mins, 1, 2, 4, 8, 12, 24hours post dose
Title
Trough Forced Expiratory Volume in 1 Second (FEV1) Following 1 Day of Treatment
Description
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 1 dose.
Time Frame
Day 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Effects of Indacaterol Maleate (QAB149) as a New Formulation in the EPIC Test Fixture
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