CompletedNCT00927901Updated Sep 9, 2013Results posted

Efficacy, Safety, Tolerability, and Pharmacokinetics of Indacaterol Salts in Patients With Asthma

A Phase 2 interventional study of Indacaterol maleate 400 μg and Indacaterol acetate 400 μg in Asthma, sponsored by Novartis Pharmaceuticals. Completed at 3 sites in 3 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-09-09.

Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 30
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study summary

This study assessed the efficacy, safety, and pharmacokinetics of indacaterol salts (maleate, xinafoate and acetate) in patients with asthma.

Conditions studied

Asthma

Browse trials for

Asthma 3,921

Keywords

QAB149
asthma
indacaterol salts (acetate, maleate, and xinafoate)
orally inhaled indacaterol salts
persistent asthma

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 30 is below the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Non-smoker male and female adult patients aged 18-75 years inclusive, who have signed an informed consent form prior to initiation of any study-related procedure, including any adjustments to asthma medication prior to screening.
Patients with asthma, receiving daily treatment with inhaled corticosteroid.
Patients with a forced expiratory volume in 1 second (FEV1) during screening of ≥ 50% of the predicted normal value for the patient.
Body mass index (BMI) must be within the range 18-32 kg/m\^2 (inclusive).
Able to communicate well with the investigator and comply with the requirements of the study.

Exclusion criteria

Exclusion criteria:

A urine cotinine level greater than the local laboratory lowest level of quantification (LOQ of 500 ng/ml or lower).
Patients who have had a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to screening.
Patients who have had an emergency room visit for an asthma attack/exacerbation within 6 weeks prior to screening or any time between screening and pre-dose on day 1 of the study.
Patients who have had a respiratory tract infection within 4 weeks prior to screening or any time between screening and pre-dose on day 1 of the study.
Patients who require the use of ≥ 8 inhalations per day of the short-acting β2-agonist salbutamol/albuterol (100 μg/90 μg salbutamol/albuterol metered dose inhaler [MDI] or equivalent dose of a dry-powder inhaler [DPI]) on any 2 consecutive days from screening to randomization.
Patients diagnosed with chronic obstructive pulmonary disease (COPD) as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (2008).
Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation. Previous participation in a study with either the investigational or comparator drugs does not exclude a patient from participation in this study.
Significant illness.
History of being immunocompromised, including a positive human immunodeficiency virus (HIV) test result (ELISA and Western blot).
A positive hepatitis B surface antigen (HBsAg) or hepatitis C test result.
Patients who are considered vulnerable as per ICH GCP guidelines.
Patients with a history of hypersensitivity to indacaterol or to similar drugs including untoward reactions to sympathomimetic amines or inhaled medication or any component thereof.
Treatments for asthma and allied conditions:
The following treatments should not be used unless they have been stabilized prior to screening: antihistamines, inhaled nasal cromolyn, inhaled nasal corticosteroids, and maintenance immunotherapy.

Other protocol-defined inclusion/exclusion criteria applied to the study.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 30 participants (actual)

Study arms

Experimental
Indacaterol (ind) maleate-placebo-ind xinafoate-ind acetate
In treatment period 1, patients received indacaterol maleate 400 μg; in treatment period 2, patients received placebo to indacaterol; in treatment period 3, patients received indacaterol xinafoate 400 μg; and in treatment period 4, patients received indacaterol acetate 400 μg. Patients received each treatment once daily for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Drug: Indacaterol maleate 400 μg · Drug: Indacaterol acetate 400 μg · Drug: Indacaterol xinafoate 400 μg · Drug: Placebo to indacaterol
Experimental
Indacaterol (ind) xinafoate-ind maleate-ind acetate-placebo
In treatment period 1, patients received indacaterol xinafoate 400 μg; in treatment period 2, patients received indacaterol maleate 400 μg; in treatment period 3, patients received indacaterol acetate 400 μg; and in treatment period 4, patients received placebo to indacaterol 400 μg. Patients received each treatment once daily for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Drug: Indacaterol maleate 400 μg · Drug: Indacaterol acetate 400 μg · Drug: Indacaterol xinafoate 400 μg · Drug: Placebo to indacaterol
Experimental
Indacaterol (ind) acetate-ind xinafoate-placebo-ind maleate
In treatment period 1, patients received indacaterol acetate 400 μg; in treatment period 2, patients received indacaterol xinafoate 400 μg; in treatment period 3, patients received placebo to indacaterol; and in treatment period 4, patients received indacaterol maleate 400 μg. Patients received each treatment once daily for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Drug: Indacaterol maleate 400 μg · Drug: Indacaterol acetate 400 μg · Drug: Indacaterol xinafoate 400 μg · Drug: Placebo to indacaterol
Experimental
Placebo-indacaterol (ind) acetate-ind maleate-ind xinafoate
In treatment period 1, patients received placebo to indacaterol; in treatment period 2, patients received indacaterol acetate 400 μg; in treatment period 3, patients received indacaterol maleate 400 μg; and in treatment period 4, patients received indacaterol xinafoate 400 μg. Patients received each treatment once daily for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Drug: Indacaterol maleate 400 μg · Drug: Indacaterol acetate 400 μg · Drug: Indacaterol xinafoate 400 μg · Drug: Placebo to indacaterol

Interventions

DrugIndacaterol maleate 400 μg
Indacaterol maleate 400 μg was provided in powder filled capsules with the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol.
DrugIndacaterol acetate 400 μg
Indacaterol acetate 400 μg was provided in powder filled capsules with the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol.
DrugIndacaterol xinafoate 400 μg
Indacaterol xinafoate 400 μg was provided in powder filled capsules with the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol.
DrugPlacebo to indacaterol
Placebo to indacaterol was provided in powder filled capsules with the Concept1 single-dose dry-powder inhaler.

What researchers measure

Primary outcomes

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Each Treatment Period (Day 7)
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Baseline and at the end of each treatment period. The analysis included period baseline FEV1 as covariate.
Time frame: Baseline to the end of each treatment period (Day 7)

Secondary outcomes

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 1
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Baseline and on Day 1. The analysis included period baseline FEV1 as covariate.
Time frame: Baseline to Day 1
Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 7
FEV1 was measured with spirometry conducted according to internationally accepted standards at 5, 15, and 30 minutes; 1 hour, 1 hour 30 minutes; and 2, 4, and 12 hours post-dose on Day 1 and Day 7.
Time frame: Day 1 and Day 7
Percentage of Patients Using Rescue Medication During Each 7 Day Treatment Period
Patients recorded use of rescue medication (salbutamol/albuterol multi-dose inhaler) as the number of puffs taken in respective preceding 12 hours morning and evening in a diary. Patient with any use of rescue medication (any number of puffs \> 0) was included to calculate endpoint.
Time frame: Baseline to the end of each treatment period (Day 7)
Indacaterol Exposure (AUC[0-24 Hours]) at the End of Each 7 Day Treatment Period
Venous blood samples for pharmacokinetic evaluation were collected at 15 and 30 minutes; and 1, 2, 4, 12, and 24 hours post-dose at the end of each 7 day treatment period and were analyzed using a LC-MS/MS assay. Area under the concentration-time curve up to 24 hours (AUC\[0-24 hours\]) was calculated from concentration-time data and recorded sampling times using non-compartmental methods.
Time frame: End of each treatment period (Day 7)
Indacaterol Exposure (Cmax) at the End of Each 7 Day Treatment Period
Venous blood samples for pharmacokinetic evaluation were collected at 15 and 30 minutes; and 1, 2, 4, 12, and 24 hours post-dose at the end of each 7 day treatment period and were analyzed using a LC-MS/MS assay. Maximum (peak) plasma drug concentration after drug administration (Cmax) was calculated from concentration-time data and recorded sampling times using non-compartmental methods.
Time frame: End of each treatment period (Day 7)

Results

Posted Aug 30, 2011

Participant flow

Treatment Period 1

Participant flow — Treatment Period 1
Milestone	Indacaterol (Ind) Maleate-placebo-ind Xinafoate-ind Acetate	Indacaterol (Ind) Xinafoate-ind Maleate-ind Acetate-placebo	Indacaterol (Ind) Acetate-ind Xinafoate-placebo-ind Maleate	Placebo-indacaterol (Ind) Acetate-ind Maleate-ind Xinafoate
Started	7	7	7	9
Completed	7	7	6	9
Not completed	0	0	1	0
Withdrew: Subject withdrew consent	0	0	1	0

Treatment Period 2

Participant flow — Treatment Period 2
Milestone	Indacaterol (Ind) Maleate-placebo-ind Xinafoate-ind Acetate	Indacaterol (Ind) Xinafoate-ind Maleate-ind Acetate-placebo	Indacaterol (Ind) Acetate-ind Xinafoate-placebo-ind Maleate	Placebo-indacaterol (Ind) Acetate-ind Maleate-ind Xinafoate
Started	7	7	6	9
Completed	7	7	6	9
Not completed	0	0	0	0

Treatment Period 3

Participant flow — Treatment Period 3
Milestone	Indacaterol (Ind) Maleate-placebo-ind Xinafoate-ind Acetate	Indacaterol (Ind) Xinafoate-ind Maleate-ind Acetate-placebo	Indacaterol (Ind) Acetate-ind Xinafoate-placebo-ind Maleate	Placebo-indacaterol (Ind) Acetate-ind Maleate-ind Xinafoate
Started	7	7	6	9
Completed	7	7	6	9
Not completed	0	0	0	0

Treatment Period 4

Participant flow — Treatment Period 4
Milestone	Indacaterol (Ind) Maleate-placebo-ind Xinafoate-ind Acetate	Indacaterol (Ind) Xinafoate-ind Maleate-ind Acetate-placebo	Indacaterol (Ind) Acetate-ind Xinafoate-placebo-ind Maleate	Placebo-indacaterol (Ind) Acetate-ind Maleate-ind Xinafoate
Started	7	7	6	9
Completed	7	7	5	8
Not completed	0	0	1	1
Withdrew: Adverse event	0	0	0	1
Withdrew: Subject withdrew consent	0	0	1	0

Outcome measures

PrimaryChange From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Each Treatment Period (Day 7)

FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Baseline and at the end of each treatment period. The analysis included period baseline FEV1 as covariate.

Time frame:: Baseline to the end of each treatment period (Day 7)
Reported as:: Least squares mean · Liters

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Each Treatment Period (Day 7)
Liters	Indacaterol Maleate 400 μg	Indacaterol Acetate 400 μg	Indacaterol Xinafoate 400 μg	Placebo to Indacaterol
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Each Treatment Period (Day 7)	0.186 (0.1079 to 0.2649)	0.190 (0.1133 to 0.2673)	0.194 (0.1164 to 0.2728)	-0.021 (-0.0982 to 0.0558)

SecondaryChange From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 1

FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Baseline and on Day 1. The analysis included period baseline FEV1 as covariate.

Time frame:: Baseline to Day 1
Reported as:: Least squares mean · Liters

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 1
Liters	Indacaterol Maleate 400 μg	Indacaterol Acetate 400 μg	Indacaterol Xinafoate 400 μg	Placebo to Indacaterol
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 1	0.161 (0.0877 to 0.2344)	0.185 (0.1129 to 0.2572)	0.205 (0.1325 to 0.2792)	0.008 (-0.0649 to 0.0819)

SecondaryTime to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 7

FEV1 was measured with spirometry conducted according to internationally accepted standards at 5, 15, and 30 minutes; 1 hour, 1 hour 30 minutes; and 2, 4, and 12 hours post-dose on Day 1 and Day 7.

Time frame:: Day 1 and Day 7
Reported as:: Median · Hours

Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 7
Hours	Indacaterol Maleate 400 μg	Indacaterol Acetate 400 μg	Indacaterol Xinafoate 400 μg	Placebo to Indacaterol
Day 1, N=29, 30, 29, 29	4.00 (3.000 to 6.125)	2.13 (1.500 to 3.000)	1.50 (1.040 to 2.500)	2.25 (1.500 to 12.085)
Day 7, N=28, 29, 28, 29	3.00 (2.000 to 4.000)	2.50 (1.500 to 4.000)	3.00 (1.250 to 12.000)	12.38 (11.710 to 13.875)

SecondaryPercentage of Patients Using Rescue Medication During Each 7 Day Treatment Period

Patients recorded use of rescue medication (salbutamol/albuterol multi-dose inhaler) as the number of puffs taken in respective preceding 12 hours morning and evening in a diary. Patient with any use of rescue medication (any number of puffs \> 0) was included to calculate endpoint.

Time frame:: Baseline to the end of each treatment period (Day 7)
Reported as:: Number · Percentage of participants

Percentage of Patients Using Rescue Medication During Each 7 Day Treatment Period
Percentage of participants	Indacaterol Maleate 400 μg	Indacaterol Acetate 400 μg	Indacaterol Xinafoate 400 μg	Placebo to Indacaterol
Percentage of Patients Using Rescue Medication During Each 7 Day Treatment Period	21	10	17	21

SecondaryIndacaterol Exposure (AUC[0-24 Hours]) at the End of Each 7 Day Treatment Period

Venous blood samples for pharmacokinetic evaluation were collected at 15 and 30 minutes; and 1, 2, 4, 12, and 24 hours post-dose at the end of each 7 day treatment period and were analyzed using a LC-MS/MS assay. Area under the concentration-time curve up to 24 hours (AUC\[0-24 hours\]) was calculated from concentration-time data and recorded sampling times using non-compartmental methods.

Time frame:: End of each treatment period (Day 7)
Reported as:: Geometric mean · pg * hr/mL

Indacaterol Exposure (AUC[0-24 Hours]) at the End of Each 7 Day Treatment Period
pg * hr/mL	Indacaterol Acetate 400 μg	Indacaterol Maleate 400 μg	Indacaterol Xinafoate 400 μg
Indacaterol Exposure (AUC[0-24 Hours]) at the End of Each 7 Day Treatment Period	5159 ± 27.9	5434 ± 30.7	5170 ± 24.2

SecondaryIndacaterol Exposure (Cmax) at the End of Each 7 Day Treatment Period

Venous blood samples for pharmacokinetic evaluation were collected at 15 and 30 minutes; and 1, 2, 4, 12, and 24 hours post-dose at the end of each 7 day treatment period and were analyzed using a LC-MS/MS assay. Maximum (peak) plasma drug concentration after drug administration (Cmax) was calculated from concentration-time data and recorded sampling times using non-compartmental methods.

Time frame:: End of each treatment period (Day 7)
Reported as:: Geometric mean · pg/mL

Indacaterol Exposure (Cmax) at the End of Each 7 Day Treatment Period
pg/mL	Indacaterol Acetate 400 μg	Indacaterol Maleate 400 μg	Indacaterol Xinafoate 400 μg
Indacaterol Exposure (Cmax) at the End of Each 7 Day Treatment Period	720 ± 35.5	753 ± 40.6	664 ± 26.4

Adverse events

Collected over Baseline to the end of the study (approximately 11 weeks). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Indacaterol Acetate 400 μg	—	0/30 (0%)	5/30 (16.7%)
Indacaterol Maleate 400 μg	—	0/29 (0%)	4/29 (13.8%)
Indacaterol Xinafoate 400 μg	—	0/29 (0%)	7/29 (24.1%)
Placebo to Indacaterol	—	0/29 (0%)	5/29 (17.2%)

Most frequent other events

Most frequent other events
Event	Indacaterol Acetate 400 μg	Indacaterol Maleate 400 μg	Indacaterol Xinafoate 400 μg	Placebo to Indacaterol
NasopharyngitisInfections and infestations	0/30	0/29	4/29	1/29
HeadacheNervous system disorders	1/30	1/29	2/29	4/29
CoughRespiratory, thoracic and mediastinal disorders	4/30	3/29	2/29	0/29

Baseline characteristics

Age Continuous
Age Continuous(years)	Entire Study Population
Mean	50 ± 12.3

Sex: Female, Male
Sex: Female, Male(Participants)	Entire Study Population
Female	7
Male	23

Study locations

3 sites

Novartis Investigative Site
Poitiers, France
Novartis Investigative Site
Wiesbaden, Germany
Novartis Investigative Site
Verona, Italy

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 9, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00927901
Lead sponsor: Novartis Pharmaceuticals
Responsible party: Sponsor
First posted: Jun 25, 2009
Start date: Jun 2009
Primary completion: Nov 2009
Completion: Nov 2009
Results posted: Aug 30, 2011
Last update: Sep 9, 2013

Study contacts

Novartis Pharmaceuticals

study director · Novartis Pharmaceuticals

View the source record on ClinicalTrials.gov ↗

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