Safety of Indacaterol in Patients (≥ 12 Years) With Moderate to Severe Persistent Asthma

August 25, 2011 updated by: Novartis Pharmaceuticals

A 26-week Treatment, Randomized, Multicenter, Double-blind, Double-dummy, Parallel-group Study to Assess the Safety of Indacaterol (300 and 600 µg o.d.) in Patients With Moderate to Severe Persistent Asthma, Using Salmeterol (50 µg b.i.d.) as an Active Control

This study was designed to assess the safety of indacaterol (300 µg and 600 µg (2 x 300 μg capsules) once daily [od]), compared with salmeterol (50 μg twice a day [b.i.d.]), over 26 weeks, in patients with moderate to severe persistent asthma.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
805

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Novartis Investigator Site
      • Cordoba, Argentina
        • Novartis Investigator Site
      • Rosario, Argentina
        • Novartis Investigator Site
      • San Miguel de Tucuman, Argentina
        • Novartis Investigator Site
  • Canada
      • Halifax, Canada
        • Novartis Investigator Site
      • London, Canada
        • Novartis Investigator Site
      • Mississauga, Canada
        • Novartis Investigator Site
      • Montreal, Canada
        • Novartis Investigator Site
      • Ste-Foy, Canada
        • Novartis Investigator Site
  • Czech Republic
      • Brno, Czech Republic
        • Novartis Investigator Site
      • Praha, Czech Republic
        • Novartis Investigative Site
      • Praha, Czech Republic
        • Novartis Investigator Site
  • France
      • Brest cedex, France
        • Novartis Investigator Site
      • Castelnau-le-Lez, France
        • Novartis Investigator Site
      • Chauny, France
        • Novartis Investigator Site
      • Paris Cedex 14, France
        • Novartis Investigator Site
      • Tarbes Cedex, France
        • Novartis Investigator Site
      • Vandoeuvre Les Nancy, France
        • Novartis Investigator Site
  • Germany
      • Berlin, Germany
        • Novartis Investigator Site
      • Bochum, Germany
        • Novartis Investigator Site
      • Borstel, Germany
        • Novartis Investigator Site
      • Geesthacht, Germany
        • Novartis Investigator Site
      • Hamburg, Germany
        • Novartis Investigator Site
      • Kiel, Germany
        • Novartis Investigator Site
      • Leipzig, Germany
        • Novartis Investigator Site
      • Luebeck, Germany
        • Novartis Investigator Site
      • Mainz, Germany
        • Novartis Investigator Site
      • Marburg, Germany
        • Novartis Investigator Site
      • Neumunster, Germany
        • Novartis Investigator Site
      • Neuss, Germany
        • Novartis Investigator Site
      • Schwetzingen, Germany
        • Novartis Investigator Site
      • Wiesloch, Germany
        • Novartis Investigator Site
      • Wittem, Germany
        • Novartis Investigator Site
  • Hungary
      • Debrecen, Hungary
        • Novartis Investigator Site
      • Nyiregyhaza, Hungary
        • Novartis Investigator Site
      • Sopron, Hungary
        • Novartis Investigator Site
      • Szombathely, Hungary
        • Novartis Investigator Site
      • Tatabanya, Hungary
        • Novartis Investigator Site
  • Italy
      • Brescia, Italy
        • Novartis Investigator Site
      • Catania, Italy
        • Novartis Investigator Site
      • Modena, Italy
        • Novartis Investigator Site
      • Parma, Italy
        • Novartis Investigator Site
      • Pietra Ligure, Italy
        • Novartis Investigator Site
      • Pisa, Italy
        • Novartis Investigator Site
      • Terni, Italy
        • Novartis Investigator Site
      • Torino, Italy
        • Novartis Investigator Site
      • Trieste, Italy
        • Novartis Investigator Site
  • Peru
      • Lima, Peru
        • Novartis Investigator Site
  • Slovakia
      • Bardejov, Slovakia
        • Novartis Investigator Site
      • Bratislava, Slovakia
        • Novartis Investigator Site
      • Kosice, Slovakia
        • Novartis Investigator Site
      • Nitra, Slovakia
        • Novartis Investigator Site
      • Trencin, Slovakia
        • Novartis Investigator Site
  • Spain
      • Alicante, Spain
        • Novartis Investigator Site
      • Barcelona, Spain
        • Novartis Investigator Site
      • Begonte, Spain
        • Novartis Investigator Site
      • Caceres, Spain
        • Novartis Investigator Site
      • Cádiz, Spain
        • Novartis Investigator Site
      • Granollers, Spain
        • Novartis Investigator Site
      • Hospitalet de Llobregat, Spain
        • Novartis Investigative Site
      • Hostalets de Balenyà, Spain
        • Novartis Investigator Site
      • Illescas, Spain
        • Novartis Investigator Site
      • Mataró, Spain
        • Novartis Investigator Site
      • Oviedo, Spain
        • Novartis Investigator Site
      • Sevilla, Spain
        • Novartis Investigator Site
      • Valencia, Spain
        • Novartis Investigator Site
  • Turkey
      • Ankara, Turkey
        • Novartis Investigator Site
      • Istanbul, Turkey
        • Novartis Investigator Site
      • Istanbul, Turkey
        • Novartis Investigative Site
      • Izmir, Turkey
        • Novartis Investigator Site
  • United States
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Novartis Investigator Site
      • Phoenix, Arizona, United States, 85306
        • Novartis Investigator Site
    • California
      • Encinitas, California, United States, 92024
        • Novartis Investigator Site
      • Huntington Beach, California, United States, 92647
        • Novartis Investigator Site
      • Long Beach, California, United States, 90806
        • Novartis Investigator Site
      • Long Beach, California, United States, 90808
        • Novartis Investigator Site
      • Oakland, California, United States, 94609
        • Novartis Investigator Site x 2 sites
      • Orange, California, United States, 92868
        • Novartis Investigator Site
      • Palmdale, California, United States, 93551
        • Novartis Investigator Site
      • San Diego, California, United States, 92123
        • Novartis Investigator Site
      • San diego, California, United States, 92120
        • Novartis Investigator Site
      • Walnut Creek, California, United States, 94598
        • Novartis Investigator Site
      • los Angeles, California, United States, 90025
        • Novartis Investigator Site
    • Colorado
      • Denver, Colorado, United States, 80206
        • Novartis Investigator Site
      • Denver, Colorado, United States, 80230
        • Novartis Investigator Site
      • Englewood, Colorado, United States, 80112
        • Novartis Investigator Site
      • Lakewood, Colorado, United States, 80401
        • Novartis Investigator Site
    • Florida
      • Brandon, Florida, United States, 33511
        • Novartis Investigator Site
      • Largo, Florida, United States, 33770
        • Novartis Investigator Site
      • Miami, Florida, United States, 33143
        • Novartis Investigator Site
      • Panama City, Florida, United States, 32405
        • Novartis Investigator Site
      • Pensacola, Florida, United States, 32503
        • Novartis Investigator Site
      • Pensacola, Florida, United States, 32514
        • Novartis Investigator Site x 2 sites
      • Tamarac, Florida, United States, 33321
        • Novartis Investigator Site
    • Georgia
      • Albany, Georgia, United States, 31707
        • Novartis Investigator Site
      • Stockbridge, Georgia, United States, 30281
        • Novartis Investigator Site
    • Kansas
      • Overland Park, Kansas, United States, 66215
        • Novartis Investigator Site
      • Topeka, Kansas, United States, 66606
        • Novartis Investigator Site
      • overland Park, Kansas, United States, 66210
        • Novartis Investigator Site
    • Kentucky
      • Florence, Kentucky, United States, 41017
        • Novartis Investigator Site
    • Maryland
      • Baltimore, Maryland, United States, 21236
        • Novartis Investigator Site
      • Wheaton, Maryland, United States, 20902
        • Novartis Investigator Site
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
        • Novartis Investigator Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Novartis Investigator Site
      • Ypsilanti, Michigan, United States, 48197
        • Novartis Investigator Site
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Novartis Investigator Site
      • St louis, Missouri, United States, 63141
        • Novartis Investigator Site
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Novartis Investigator Site
      • Omaha, Nebraska, United States, 68131
        • Novartis Investigator Site
    • New Jersey
      • Northfield, New Jersey, United States, 08225
        • Novartis Investigator Site
    • New York
      • Rockville Centre, New York, United States, 11570
        • Novartis Investigator Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Novartis Investigator Site
      • High Point, North Carolina, United States, 27262
        • Novartis Investigator Site
      • Winston-Salem, North Carolina, United States, 27103
        • Novartis Investigator Site
    • Ohio
      • Cincinnati, Ohio, United States, 45252
        • Novartis Investigator Site
      • Toledo, Ohio, United States, 43617
        • Novartis Investigator Site
    • Oklahoma
      • Edmond, Oklahoma, United States, 73003
        • Novartis Investigator Site
      • Oklahoma City, Oklahoma, United States, 73120
        • Novartis Investigator Site
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Novartis Investigator Site
    • Texas
      • Dallas, Texas, United States, 75231
        • Novartis Investigator Site
      • Houston, Texas, United States, 77024
        • Novartis Investigator Site
      • Houston, Texas, United States, 77030
        • Novartis Investigator Site
      • Houston, Texas, United States, 77054
        • Novartis Investigator Site
      • Houston, Texas, United States, 77070
        • Novartis Investigator Site
    • Washington
      • Kirkland, Washington, United States, 98034
        • Novartis Investigator Site
      • Seattle, Washington, United States, 98105
        • Novartis Investigator Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male and female patients aged ≥ 12 years (or ≥ 18 years depending upon regulatory and/or Institutional Review Board/Independent Ethics Committee/Research Ethics Board [IRB/IEC/REB] approval) who have signed an informed consent form.

  2. Patients with moderate to severe persistent asthma, diagnosed according to the Global Initiative for Asthma (GINA) guidelines (Updated 2006) and who additionally meet the following criteria:

    • Patients who have used treatment with a bronchodilator, either regularly or on-demand, and who had used a daily dose of at least 100 μg beclomethasone dipropionate (or equivalent) for at least 1 month prior to screening.
    • Patients whose forced expiratory volume in 1 second (FEV1) is ≥ 50% of the predicted normal value.
    • Patients with documented (in the previous 6 months) or who demonstrate (prior to randomization) a ≥ 12% and at least 200 ml increase in FEV1, after inhaling 200 μg salbutamol.

Exclusion Criteria:

  1. Pregnant or nursing (lactating) women and women of child-bearing potential UNLESS they meet pre-specified definitions of post-menopausal or are using pre-specified acceptable methods of contraception.
  2. Patients who have used tobacco products within the 12 month period prior to screening, or who have a smoking history of greater than 10 pack years.
  3. Patients who suffer from chronic obstructive pulmonary disease (COPD) as diagnosed by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (2006).
  4. Patients who have had emergency room treatment for an acute asthma attack in the 6 weeks prior to screening or who have been hospitalized for an acute asthma attack in the 6 months prior to screening, or at any time between screening and Week 1.
  5. Patients with diabetes Type I or those with uncontrolled diabetes Type II including patients with a history of blood glucose levels consistently outside the normal range or glycosylated hemoglobin (HbA1C) > 8.0% measured at screening.
  6. Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically significant condition or a clinically relevant laboratory abnormality that might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study.
  7. Patients with a history of long QT syndrome, or whose QTc interval (Bazett's formula) is prolonged to > 450 ms (males) or > 470 ms (females).
  8. Certain medications for asthma and allied conditions such as long-acting bronchodilators must not be used prior to screening and for a pre-specified minimum washout period.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Indacaterol 300 μg
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 07:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). 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 300 μg
Indacaterol was supplied as powder filled capsules together with a single dose dry powder inhaler (SDDPI).
Drug: Placebo to indacaterol
Placebo to indacaterol was supplied as powder filled capsules together with a single dose dry powder inhaler (SDDPI).
Drug: Placebo to salmeterol
Placebo to salmeterol was supplied as powder filled capsules together with the manufacturer's proprietary dry powder inhalation device.
Experimental: Indacaterol 600 μg
Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 07:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). 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 300 μg
Indacaterol was supplied as powder filled capsules together with a single dose dry powder inhaler (SDDPI).
Drug: Placebo to salmeterol
Placebo to salmeterol was supplied as powder filled capsules together with the manufacturer's proprietary dry powder inhalation device.
Active Comparator: Salmeterol 50 μg
Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 07:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. 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: Placebo to indacaterol
Placebo to indacaterol was supplied as powder filled capsules together with a single dose dry powder inhaler (SDDPI).
Drug: Salmeterol 50 μg
Salmeterol was supplied as powder filled capsules together with the manufacturer's proprietary dry powder inhalation device.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Patients With at Least 1 Adverse Event During the 26 Weeks of the Study
Time Frame: Baseline (Day 1) to end of study (Week 26)
Adverse events include asthma exacerbations. An asthma exacerbation was defined as a worsening of asthma as judged clinically significant by the physician, requiring treatment with rescue oral or intravenous (IV) corticosteroids. Asthma worsening that required treatment with inhaled or nebulized short-acting β2-agonists or an increase in inhaled corticosteroids only was not considered an asthma exacerbation.
Baseline (Day 1) to end of study (Week 26)
Systolic Blood Pressure 1 Hour Post-dose at Day 1
Time Frame: Day 1
Systolic blood pressure measurements (in millimeters of mercury, mmHg) were made 1 hour post-dose after the patient had rested in the sitting position for at least 10 minutes. Measurements were made using an inflatable cuff around the upper arm. The analysis included baseline systolic blood pressure and forced expiratory volume in 1 second (FEV1) pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.
Day 1
Systolic Blood Pressure 1 Hour Post-dose at Week 12
Time Frame: Week 12
Systolic blood pressure measurements (in millimeters of mercury, mmHg) were made 1 hour post-dose after the patient had rested in the sitting position for at least 10 minutes. Measurements were made using an inflatable cuff around the upper arm. The analysis included baseline systolic blood pressure and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.
Week 12
Diastolic Blood Pressure 1 Hour Post-dose at Day 1
Time Frame: Day 1
Diastolic blood pressure measurements (in millimeters of mercury, mmHg) were made 1 hour post-dose after the patient had rested in the sitting position for at least 10 minutes. Measurements were made using an inflatable cuff around the upper arm. Phase V Korotkoff sounds were used for determination of diastolic pressure. The analysis included baseline diastolic blood pressure and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.
Day 1
Diastolic Blood Pressure 1 Hour Post-dose at Week 12
Time Frame: Week 12
Diastolic blood pressure measurements (in millimeters of mercury, mmHg) were made 1 hour post-dose after the patient had rested in the sitting position for at least 10 minutes. Measurements were made using an inflatable cuff around the upper arm. Phase V Korotkoff sounds were used for determination of diastolic pressure. The analysis included baseline diastolic blood pressure and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.
Week 12
Corrected QT (QTc) Interval Using Fridericia's Formula Measured 1 Hour Post-dose at Day 1
Time Frame: Day 1
The QTc interval (in milliseconds, ms) is calculated from electrocardiogram (ECG) data collected 1 hour post-dose using Fridericia's formula: QTc = QT/RR^0.33. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves. ECGs included all 12 standard leads and a Lead II rhythm strip of at least 10-second duration. All results were sent to a central laboratory for review by a cardiologist. The analysis included baseline QTc interval and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.
Day 1
Corrected QT (QTc) Interval Using Fridericia's Formula Measured 1 Hour Post-dose at Week 12
Time Frame: Week 12
The QTc interval (in milliseconds, ms) is calculated from electrocardiogram (ECG) data collected 1 hour post-dose using Fridericia's formula: QTc = QT/RR^0.33. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves. ECGs included all 12 standard leads and a Lead II rhythm strip of at least 10-second duration. All results were sent to a central laboratory for review by a cardiologist. The analysis included baseline QTc interval and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.
Week 12
Corrected QT (QTc) Interval Using Fridericia's Formula Measured 1 Hour Post-dose at Week 21
Time Frame: Week 21
The QTc interval (in milliseconds, ms) is calculated from electrocardiogram (ECG) data collected 1 hour post-dose using Fridericia's formula: QTc = QT/RR^0.33. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves. ECGs included all 12 standard leads and a Lead II rhythm strip of at least 10-second duration. All results were sent to a central laboratory for review by a cardiologist. The analysis included baseline QTc interval and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.
Week 21
24 Hour Mean Heart Rate Determined From ECG Holter Monitoring at Week 12
Time Frame: Week 12
Continuous 24 hour electrocardiography (Holter monitoring) was conducted in a subset of patients at designated study centers, and was used to calculate the mean heart rate (in beats per minute, bpm). Patients returned the Holter monitor recorder to the clinic the morning after the 24 hour recording was complete. The results of Holter monitoring were processed centrally. The analysis included baseline 24 hour mean heart rate and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.
Week 12
24 Hour Mean Heart Rate Determined From ECG Holter Monitoring at Week 26
Time Frame: Week 26
Continuous 24 hour electrocardiography (Holter monitoring) was conducted in a subset of patients at designated study centers, and was used to calculate the mean heart rate (in beats per minute, bpm). Patients returned the Holter monitor recorder to the clinic the morning after the 24 hour recording was complete. The results of Holter monitoring were processed centrally. The analysis included baseline 24 hour mean heart rate and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.
Week 26
Serum Potassium 1 Hour Post-dose at Day 1
Time Frame: Day 1
Serum potassium (in millimoles per liter, mmol/L) was measured from venous blood samples. Samples were sent to a central laboratory for analysis. The analysis included baseline serum potassium and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.
Day 1
Serum Potassium 1 Hour Post-dose at Week 12
Time Frame: Week 12
Serum potassium (in millimoles per liter, mmol/L) was measured from venous blood samples. Samples were sent to a central laboratory for analysis. The analysis included baseline serum potassium and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.
Week 12
Blood Glucose 1 Hour Post-dose at Day 1
Time Frame: Day 1
Blood glucose (in millimoles per liter, mmol/L) was measured from venous blood samples. Samples were sent to a central laboratory for analysis. The analysis included baseline blood glucose and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.
Day 1
Blood Glucose 1 Hour Post-dose at Week 12
Time Frame: Week 12
Blood glucose (in millimoles per liter, mmol/L) was measured from venous blood samples. Samples were sent to a central laboratory for analysis. The analysis included baseline blood glucose and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.
Week 12
Percentage of Patients With Clinically Significant Asthma Exacerbations During the 26 Weeks of the Study
Time Frame: Baseline (Day 1) to end of study (Week 26)
A clinically significant asthma exacerbation was defined as a worsening of asthma as judged clinically significant by the physician, requiring treatment with systemic corticosteroids. This includes events recorded on the asthma exacerbation clinical report form (CRF) page and events recorded on the adverse events CRF page with "asthma" as a key word in the preferred term.
Baseline (Day 1) to end of study (Week 26)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at Week 12 + 1 Day, Day 85
Time Frame: 24 hours post-dose at Week 12 + 1 day, Day 85
FEV1 (in liters, L) 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 Week 12, Day 85. The analysis included baseline FEV1 and FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening as covariates.
24 hours post-dose at Week 12 + 1 day, Day 85
Number of Asthma Exacerbations Per Patient (Without Imputation) During the 26 Weeks of the Study
Time Frame: Baseline (Day 1) to end of study (Week 26)
An asthma exacerbation was defined as a worsening of asthma as judged clinically significant by the physician, requiring treatment with rescue oral or intravenous (IV) corticosteroids. The number of asthma exacerbations includes events recorded on the asthma exacerbation clinical report form (CRF) page and events recorded on the adverse events CRF page with "asthma" as a key word in the preferred term.
Baseline (Day 1) to end of study (Week 26)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 29, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2011

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Terms related to this study

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Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CQAB149B2338

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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