Back to results

Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate in Patients With Persistent Asthma

Primary Purpose

Asthma

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

indacaterol

placebo

mometasone furoate

About this trial

This is an interventional treatment trial for Asthma focused on measuring asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with persistent asthma, diagnosed according to GINA 2010 guideline and who additionally meet the following criteria:
Patients who are receiving ICS treatment in a stable regimen for ≥ 4 weeks
Patients with a pre-bronchodilator FEV1 value of ≥ 40% and ≤ 80% of predicted normal value
Patients who demonstrate an increase of >= 12% and 200 mL in FEV1
ACQ-5 score ≥ 1.5

Exclusion Criteria:

Patients who are current smokers or have a smoking history of greater than 10 pack years (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked).
Patients with chronic lung disease, including COPD, pulmonary tuberculosis, bronchiectasis, sarcoidosis, interstitial lung disease and cystic fibrosis.
Patients with any chronic conditions affecting the respiratory tract (e.g., chronic sinusitis) which in the opinion of the investigator may interfere with the study evaluation or optimal participation in the study.

Other protocol-defined inclusion/exclusion criteria may apply

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

indacaterol acetate 75 µg

indacaterol acetate 150 µg

placebo

Arm Description

indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od

indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od

placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od

Outcomes

Primary Outcome Measures

Trough Forced Expiratory Volume in One Second (FEV1) After 12 Weeks (Day 85)

Forced Expiratory Volume in 1 second (FEV1) was measured via 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 after 12 weeks (Day 85)

Secondary Outcome Measures

Asthma Control Questionnaire 5 (ACQ-5) After 12 Weeks (Day 85)

The Asthma Control Questionnaire (ACQ-5) is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled). A negative change in score indicates improvement in symptoms. MIXED model: Change from baseline in ACQ-5 = treatment + gender + baseline ACQ-5 score + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.

Trough Forced Expiratory Volume in One Second (FEV1) After 2 Weeks (Day 15), 4 Weeks (Day 29), and 8 Weeks (Day 57) of Treatment.

Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points

Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards. FVC is measured on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at all time points

Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85

Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards.

Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85

Forced Expiratory Flow (FEF 25-75%) was measured via spirometry conducted according to internationally accepted standards.

Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)

Forced Expiratory Volume in 1 second (FEV1)/Area Under the Curve(AUC) was measured via spirometry conducted according to internationally accepted standards.FEV1 AUC(5 min - 4 h), (5 min - 1 h) and (1 h - 4 h) are measured at Day 1, 2 Weeks (Day 14) and 12 Weeks (Day84) and defined as average of FEV1 at specified timepoints above.

Peak Forced Expiratory Volume in 1 Second (FEV1) at Day 1, 2 Weeks (Day 14), 12 Weeks (Day 84)

Peak Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Peak FEV1 is defined as the maximum FEV1 during the first 4 h post morning dosing at Day 1, 2Weeks and 12 Weeks.

Asthma Control Questionnaire 5 (ACQ-5) After 4 Weeks (Day 29) and After 8 Weeks (Day 57) of Treatment

The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).

Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 12 Weeks of Treatment. This is LS Mean of the Treatment Period.

PEFR is measured with portable spirometer by participants every morning and evening at home.

The Usage of Rescue Medication (Short Acting β2-agonist) Over 12 Weeks of Treatment

Participants record the number of puffs of rescue medication taken in the previous 12 hours in the morning and nighttime.

Asthma Quality of Life Questionnaire (AQLQ(S)) After 4 Weeks (Day 29) and 12 Weeks (Day 85) of Treatment

The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score.

Time to First Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period

Duration of treatment until first asthma exacerbation by severity of exacerbation. A severe asthma exacerbation is systemic corticosteroids (SCS) use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.

The Annual Rate of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period

Annual incidence rate of asthma exacerbation by severity of exacerbation. The number of asthma exacerbation is used to calculate annual incidence rate. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations. Number of the asthma exacerbation will be analyzed by the negative binomial regression including treatment, history of asthma exacerbation in the 12 months prior to screening and region as factors and FEV1 prior to inhalation and FEV1 30 min post inhalation of salbutamol/albuterol (components of SABA reversibility) as covariates. The estimates are obtained from the model and so we cannot specify a formula.

Duration of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period

Duration of asthma exacerbations by severity of exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.

The Percentage of Patients With at Least One Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period

The percentage of patients with at least one asthma exacerbation by severity of exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.

Time to Permanent Study Discontinuation Due to Asthma Exacerbation Over the 12 Week Treatment Period

Time to permanent study discontinuation due to asthma exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.

The Percentage of Patients Who Permanently Discontinued Study Due to Asthma Exacerbation Over the 12 Week Treatment Period

The percentage of patients who permanently discontinued study due to asthma exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.

Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period

Total amounts (in doses) of systemic corticosteroids (SCS) used to treat asthma exacerbations.SCS includes Intramuscular (IM), Intravenous (IV) and Oral. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.

Plasma Indacaterol Concentrations at Day 1 and Day 14

Maximum plasma concentration after drug administration (Cmax) was measured for indacaterol acetate 75 µg and indacaterol acetate 150 µg for Pharmacokinetic (PK) Subgroup

Full Information

NCT ID

NCT01609478

First Posted

April 23, 2012

Last Updated

January 15, 2015

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01609478

Brief Title

Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate in Patients With Persistent Asthma

Official Title

A Multicenter, Randomized, Double-blind, Placebo-controlled, 12-week Treatment, Parallel-group Study to Assess the Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate (75 and 150 µg o.d.) in Patients With Persistent Asthma

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Completed

Study Start Date

August 2012 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To provide the efficacy, safety and pharmacokinetics of indacaterol acetate in patients with persistent asthma to support dose selection of indacaterol in fixed dose combination QMF149.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

335 (Actual)

8. Arms, Groups, and Interventions

Arm Title

indacaterol acetate 75 µg

Arm Type

Experimental

Arm Description

indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od

Arm Title

indacaterol acetate 150 µg

Arm Type

Experimental

Arm Description

indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od

Intervention Type

Drug

Intervention Name(s)

indacaterol

Intervention Description

indacaterol acetate 75 µg or indacaterol acetate 150 µg delivered via Concept 1 inhaler

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

placebo delivered via Concept 1 inhaler

Intervention Type

Drug

Intervention Name(s)

mometasone furoate

Intervention Description

via Twisthaler inhaler

Primary Outcome Measure Information:

Title

Trough Forced Expiratory Volume in One Second (FEV1) After 12 Weeks (Day 85)

Description

Time Frame

after 12 weeks (Day 85)

Secondary Outcome Measure Information:

Title

Asthma Control Questionnaire 5 (ACQ-5) After 12 Weeks (Day 85)

Description

Time Frame

aftert 12 weeks (Day 85)

Title

Trough Forced Expiratory Volume in One Second (FEV1) After 2 Weeks (Day 15), 4 Weeks (Day 29), and 8 Weeks (Day 57) of Treatment.

Description

Time Frame

Day 15, Day 29 and Day 57

Title

Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points

Description

Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards. FVC is measured on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at all time points

Time Frame

Day 1, Day 2, Day 14, Day 15, Day 84, Day 85

Title

Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85

Description

Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards.

Time Frame

Day 1, Day 2, Day 14, Day 15, Day 84, Day 85

Title

Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85

Description

Forced Expiratory Flow (FEF 25-75%) was measured via spirometry conducted according to internationally accepted standards.

Time Frame

Day 1, Day 2, Day 14, Day 15, Day 84, Day 85

Title

Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)

Description

Time Frame

Day 1, 2 Weeks, 12 Weeks

Title

Peak Forced Expiratory Volume in 1 Second (FEV1) at Day 1, 2 Weeks (Day 14), 12 Weeks (Day 84)

Description

Time Frame

Day 1, 2 weeks (Day 14), 12 weeks (Day 84)

Title

Asthma Control Questionnaire 5 (ACQ-5) After 4 Weeks (Day 29) and After 8 Weeks (Day 57) of Treatment

Description

Time Frame

after 4 weeks (Day 29) and after 8 weeks (Day 57)

Title

Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 12 Weeks of Treatment. This is LS Mean of the Treatment Period.

Description

PEFR is measured with portable spirometer by participants every morning and evening at home.

Time Frame

baseline, 4weeks, 8 weeks and 12 weeks

Title

The Usage of Rescue Medication (Short Acting β2-agonist) Over 12 Weeks of Treatment

Description

Participants record the number of puffs of rescue medication taken in the previous 12 hours in the morning and nighttime.

Time Frame

12 weeks

Title

Asthma Quality of Life Questionnaire (AQLQ(S)) After 4 Weeks (Day 29) and 12 Weeks (Day 85) of Treatment

Description

Time Frame

4 Weeks, 12 Weeks

Title

Time to First Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period

Description

Time Frame

12 weeks

Title

The Annual Rate of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period

Description

Time Frame

12 weeks

Title

Duration of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period

Description

Time Frame

12 weeks

Title

The Percentage of Patients With at Least One Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period

Description

Time Frame

12 weeks

Title

Time to Permanent Study Discontinuation Due to Asthma Exacerbation Over the 12 Week Treatment Period

Description

Time Frame

12 weeks

Title

The Percentage of Patients Who Permanently Discontinued Study Due to Asthma Exacerbation Over the 12 Week Treatment Period

Description

Time Frame

12 weeks

Title

Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period

Description

Time Frame

12 weeks

Title

Plasma Indacaterol Concentrations at Day 1 and Day 14

Description

Maximum plasma concentration after drug administration (Cmax) was measured for indacaterol acetate 75 µg and indacaterol acetate 150 µg for Pharmacokinetic (PK) Subgroup

Time Frame

Day 1 and Day 14

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with persistent asthma, diagnosed according to GINA 2010 guideline and who additionally meet the following criteria: Patients who are receiving ICS treatment in a stable regimen for ≥ 4 weeks Patients with a pre-bronchodilator FEV1 value of ≥ 40% and ≤ 80% of predicted normal value Patients who demonstrate an increase of >= 12% and 200 mL in FEV1 ACQ-5 score ≥ 1.5 Exclusion Criteria: Patients who are current smokers or have a smoking history of greater than 10 pack years (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked). Patients with chronic lung disease, including COPD, pulmonary tuberculosis, bronchiectasis, sarcoidosis, interstitial lung disease and cystic fibrosis. Patients with any chronic conditions affecting the respiratory tract (e.g., chronic sinusitis) which in the opinion of the investigator may interfere with the study evaluation or optimal participation in the study. 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

Facility Information:

Facility Name

Novartis Investigative Site

City

Lovech

ZIP/Postal Code

5500

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Ruse

ZIP/Postal Code

7002

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1000

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1233

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1234

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1463

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1606

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1612

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Varna

ZIP/Postal Code

9000

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Varna

ZIP/Postal Code

9020

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Veliko Tarnovo

ZIP/Postal Code

5000

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Brampton

State/Province

Ontario

ZIP/Postal Code

L6T 0G1

Country

Canada

Facility Name

Novartis Investigative Site

City

Downsview

State/Province

Ontario

ZIP/Postal Code

M3N 2Z9

Country

Canada

Facility Name

Novartis Investigative Site

City

Etobicoke

State/Province

Ontario

ZIP/Postal Code

M9V 4B4

Country

Canada

Facility Name

Novartis Investigative Site

City

Grimsby

State/Province

Ontario

ZIP/Postal Code

L3M 1P3

Country

Canada

Facility Name

Novartis Investigative Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 3Z5

Country

Canada

Facility Name

Novartis Investigative Site

City

Newmarket

State/Province

Ontario

ZIP/Postal Code

L3Y 5G8

Country

Canada

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 3A9

Country

Canada

Facility Name

Novartis Investigative Site

City

Woodstock

State/Province

Ontario

ZIP/Postal Code

N4S 5P5

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4J 1C5

Country

Canada

Facility Name

Novartis Investigative Site

City

Pointe-Claire

State/Province

Quebec

ZIP/Postal Code

H9R 4S3

Country

Canada

Facility Name

Novartis Investigative Site

City

St-Romuald

State/Province

Quebec

ZIP/Postal Code

G6W 5M6

Country

Canada

Facility Name

Novartis Investigative Site

City

Ste-Foy

State/Province

Quebec

ZIP/Postal Code

G1W 4R4

Country

Canada

Facility Name

Novartis Investigative Site

City

Bad Woerishofen

ZIP/Postal Code

86825

Country

Germany

Facility Name

Novartis Investigative Site

City

Bonn

ZIP/Postal Code

53123

Country

Germany

Facility Name

Novartis Investigative Site

City

Dortmund

ZIP/Postal Code

44263

Country

Germany

Facility Name

Novartis Investigative Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60596

Country

Germany

Facility Name

Novartis Investigative Site

City

Lübeck

ZIP/Postal Code

23552

Country

Germany

Facility Name

Novartis Investigative Site

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

81677

Country

Germany

Facility Name

Novartis Investigative Site

City

Wiesbaden

ZIP/Postal Code

65187

Country

Germany

Facility Name

Novartis Investigative Site

City

Wiesloch

ZIP/Postal Code

69168

Country

Germany

Facility Name

Novartis Investigative Site

City

Yanagawa

State/Province

Fukuoka

ZIP/Postal Code

832-0059

Country

Japan

Facility Name

Novartis Investigative Site

City

Obihiro

State/Province

Hokkaido

ZIP/Postal Code

080-0805

Country

Japan

Facility Name

Novartis Investigative Site

City

Sapporo-city

State/Province

Hokkaido

ZIP/Postal Code

060-0061

Country

Japan

Facility Name

Novartis Investigative Site

City

Ako-shi

State/Province

Hyogo-Ken

ZIP/Postal Code

678-0241

Country

Japan

Facility Name

Novartis Investigative Site

City

Himeji-city

State/Province

Hyogo

ZIP/Postal Code

672-8064

Country

Japan

Facility Name

Novartis Investigative Site

City

Naka-gun

State/Province

Ibaraki

ZIP/Postal Code

319-1113

Country

Japan

Facility Name

Novartis Investigative Site

City

Sakaide

State/Province

Kagawa

ZIP/Postal Code

762-0031

Country

Japan

Facility Name

Novartis Investigative Site

City

Kyoto-shi

State/Province

Kyoto-Fu

ZIP/Postal Code

615-8256

Country

Japan

Facility Name

Novartis Investigative Site

City

Tsu

State/Province

Mie

ZIP/Postal Code

514-1101

Country

Japan

Facility Name

Novartis Investigative Site

City

Oita-shi

State/Province

Oita-Ken

ZIP/Postal Code

870-0021

Country

Japan

Facility Name

Novartis Investigative Site

City

Beppu

State/Province

Oita

ZIP/Postal Code

874-0937

Country

Japan

Facility Name

Novartis Investigative Site

City

Kishiwada

State/Province

Osaka

ZIP/Postal Code

596-8501

Country

Japan

Facility Name

Novartis Investigative Site

City

Machida-shi

State/Province

Tokyo-To

ZIP/Postal Code

194-0023

Country

Japan

Facility Name

Novartis Investigative Site

City

Ota-ku

State/Province

Tokyo-To

ZIP/Postal Code

144-0035

Country

Japan

Facility Name

Novartis Investigative Site

City

Chuo-ku

State/Province

Tokyo

ZIP/Postal Code

103-0027

Country

Japan

Facility Name

Novartis Investigative Site

City

Cyuo-ku

State/Province

Tokyo

ZIP/Postal Code

104-8560

Country

Japan

Facility Name

Novartis Investigative Site

City

Itabashi-ku

State/Province

Tokyo

ZIP/Postal Code

173-8610

Country

Japan

Facility Name

Novartis Investigative Site

City

Kiyose-city

State/Province

Tokyo

ZIP/Postal Code

204-8585

Country

Japan

Facility Name

Novartis Investigative Site

City

Setagaya-ku

State/Province

Tokyo

ZIP/Postal Code

158-0097

Country

Japan

Facility Name

Novartis Investigative Site

City

Yonezawa

State/Province

Yamagata

ZIP/Postal Code

992-0045

Country

Japan

Facility Name

Novartis Investigative Site

City

Fukuoka

ZIP/Postal Code

811-1394

Country

Japan

Facility Name

Novartis Investigative Site

City

Gifu

ZIP/Postal Code

502-8558

Country

Japan

Facility Name

Novartis Investigative Site

City

Cheongju

State/Province

Chungbuk

ZIP/Postal Code

361 711

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Wonju

State/Province

Gangwon-Do

ZIP/Postal Code

220-701

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Korea

ZIP/Postal Code

110 744

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

100-032

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

152-703

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

158-710

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Rotterdam

ZIP/Postal Code

3045 PM

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Sittard-Geleen

ZIP/Postal Code

6162 BG

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Bialystok

ZIP/Postal Code

15-461

Country

Poland

Facility Name

Novartis Investigative Site

City

Bienkowka

ZIP/Postal Code

34-212

Country

Poland

Facility Name

Novartis Investigative Site

City

Bydgoszcz

ZIP/Postal Code

85-046

Country

Poland

Facility Name

Novartis Investigative Site

City

Gdansk

ZIP/Postal Code

80-958

Country

Poland

Facility Name

Novartis Investigative Site

City

Krakow

ZIP/Postal Code

31-023

Country

Poland

Facility Name

Novartis Investigative Site

City

Lodz

ZIP/Postal Code

90-242

Country

Poland

Facility Name

Novartis Investigative Site

City

Lodz

ZIP/Postal Code

90-302

Country

Poland

Facility Name

Novartis Investigative Site

City

Lublin

ZIP/Postal Code

20-044

Country

Poland

Facility Name

Novartis Investigative Site

City

Lublin

ZIP/Postal Code

20-637

Country

Poland

Facility Name

Novartis Investigative Site

City

Torun

ZIP/Postal Code

87-100

Country

Poland

Facility Name

Novartis Investigative Site

City

Wroclaw

ZIP/Postal Code

50-088

Country

Poland

Facility Name

Novartis Investigative Site

City

Znin

ZIP/Postal Code

88-400

Country

Poland

Facility Name

Novartis Investigative Site

City

Banska Bystrica

State/Province

Slovak Republic

ZIP/Postal Code

975 17

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Bardejov

State/Province

Slovak Republic

ZIP/Postal Code

085 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Levice

State/Province

Slovak republic

ZIP/Postal Code

934 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Dunajska Streda

ZIP/Postal Code

929 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Komarno

ZIP/Postal Code

945 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Kosice

ZIP/Postal Code

040 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Liptovsky Hradok

ZIP/Postal Code

033 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Liptovsky Mikulas

ZIP/Postal Code

031 23

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Nove Zamky

ZIP/Postal Code

940 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Rimavska Sobota

ZIP/Postal Code

979 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Spisská Nová Ves

ZIP/Postal Code

052 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Topolcany

ZIP/Postal Code

955 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Vysne Hagy

ZIP/Postal Code

5984

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Zvolen

ZIP/Postal Code

960 01

Country

Slovakia

12. IPD Sharing Statement

Learn more about this trial

Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate in Patients With Persistent Asthma

We'll reach out to this number within 24 hrs

Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate in Patients With Persistent Asthma

Asthma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial