AsthmaPhase 3NCT00529529
Safety of Indacaterol in Patients (≥ 12 Years) With Moderate to Severe Persistent Asthma
A Phase 3 study testing Indacaterol 300 μg and Salmeterol 50 μg in people with Asthma, run by Novartis Pharmaceuticals at 126 sites in 12 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Indacaterol 300 μg and Salmeterol 50 μg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 805 participants
- Where
- 126 sitesin 12 countries
- Study dates
- Sep 2007to Aug 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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.
- 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.
- Patients who suffer from chronic obstructive pulmonary disease (COPD) as diagnosed by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (2006).
- 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.
- 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.
- 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.
Show all 9Show fewer
- 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).
- 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.
Trial locations and contacts
126 sites in 12 countries.
126 sites in 12 countries
United States56 sites
Novartis Investigator Site
Albany, Georgia, 31707
Novartis Investigator Site
Ann Arbor, Michigan, 48106
Novartis Investigator Site
Baltimore, Maryland, 21236
Novartis Investigator Site
Brandon, Florida, 33511
Novartis Investigator Site
Charlotte, North Carolina, 28207
Novartis Investigator Site
Cincinnati, Ohio, 45252
Novartis Investigator Site
Dallas, Texas, 75231
Novartis Investigator Site
Denver, Colorado, 80206
Novartis Investigator Site
Denver, Colorado, 80230
Novartis Investigator Site
Edmond, Oklahoma, 73003
Novartis Investigator Site
Encinitas, California, 92024
Novartis Investigator Site
Englewood, Colorado, 80112
Novartis Investigator Site
Florence, Kentucky, 41017
Novartis Investigator Site
Glendale, Arizona, 85306
Novartis Investigator Site
Greenville, South Carolina, 29615
Novartis Investigator Site
High Point, North Carolina, 27262
Novartis Investigator site
Houston, Texas, 77024
Novartis Investigator Site
Houston, Texas, 77030
Novartis Investigator Site
Houston, Texas, 77054
Novartis Investigator Site
Houston, Texas, 77070
Novartis Investigator Site
Huntington Beach, California, 92647
Novartis Investigator Site
Kirkland, Washington, 98034
Novartis Investigator Site
Lakewood, Colorado, 80401
Novartis Investigator Site
Largo, Florida, 33770
Novartis Investigator Site
Long Beach, California, 90806
Novartis Investigator Site
Long Beach, California, 90808
Novartis Investigator Site
Los Angeles, California, 90025
Novartis Investigator Site
Miami, Florida, 33143
Novartis Investigator Site
North Dartmouth, Massachusetts, 02747
Novartis Investigator Site
Northfield, New Jersey, 08225
Novartis Investigator Site x 2 sites
Oakland, California, 94609
Novartis Investigator Site
Oklahoma City, Oklahoma, 73120
Novartis Investigator Site
Omaha, Nebraska, 68130
Novartis Investigator Site
Omaha, Nebraska, 68131
Novartis Investigator Site
Orange, California, 92868
Novartis Investigator Site
Overland Park, Kansas, 66210
Novartis Investigator Site
Overland Park, Kansas, 66215
Novartis Investigator Site
Palmdale, California, 93551
Novartis Investigator Site
Panama City, Florida, 32405
Novartis Investigator Site
Pensacola, Florida, 32503
Novartis Investigator Site x 2 sites
Pensacola, Florida, 32514
Novartis Investigator Site
Phoenix, Arizona, 85306
Novartis Investigator Site
Rockville Centre, New York, 11570
Novartis Investigator Site
San Diego, California, 92120
Novartis Investigator Site
San Diego, California, 92123
Novartis Investigator Site
Seattle, Washington, 98105
Novartis Investigator Site
Springfield, Missouri, 65807
Novartis Investigator Site
St Louis, Missouri, 63141
Novartis Investigator Site
Stockbridge, Georgia, 30281
Novartis Investigator Site
Tamarac, Florida, 33321
Novartis Investigator Site
Toledo, Ohio, 43617
Novartis Investigator Site
Topeka, Kansas, 66606
Novartis Investigator Site
Walnut Creek, California, 94598
Novartis Investigator Site
Wheaton, Maryland, 20902
Novartis Investigator Site
Winston-Salem, North Carolina, 27103
Novartis Investigator Site
Ypsilanti, Michigan, 48197
Germany15 sites
Novartis Investigator Site
Berlin
Novartis Investigator Site
Bochum
Novartis Investigator Site
Borstel
Novartis Investigator Site
Geesthacht
Novartis Investigator Site
Hamburg
Novartis Investigator Site
Kiel
Novartis Investigator Site
Leipzig
Novartis Investigator Site
Lübeck
Novartis Investigator Site
Mainz
Novartis Investigator Site
Marburg
Novartis Investigator Site
Neumünster
Novartis Investigator Site
Neuss
Novartis Investigator Site
Schwetzingen
Novartis Investigator Site
Wiesloch
Novartis Investigator Site
Wittem
Spain13 sites
Novartis Investigator Site
Alicante
Novartis Investigator Site
Barcelona
Novartis Investigator Site
Begonte
Novartis Investigator Site
Cáceres
Novartis Investigator Site
Cadiz
Novartis Investigator Site
Granollers
Novartis Investigator Site
Hostalets de Balenyà
Novartis Investigator Site
Illescas
Novartis Investigative Site
L'Hospitalet de Llobregat
Novartis Investigator Site
Mataró
Novartis Investigator Site
Oviedo
Novartis Investigator Site
Seville
Novartis Investigator Site
Valencia
Italy9 sites
Novartis Investigator Site
Brescia
Novartis Investigator Site
Catania
Novartis Investigator Site
Modena
Novartis Investigator Site
Parma
Novartis Investigator Site
Pietra Ligure
Novartis Investigator Site
Pisa
Novartis Investigator Site
Terni
Novartis Investigator Site
Torino
Novartis Investigator Site
Trieste
France6 sites
Novartis Investigator Site
Brest
Novartis Investigator Site
Castelnau-le-Lez
Novartis Investigator Site
Chauny
Novartis Investigator Site
Paris
Novartis Investigator Site
Tarbes
Novartis Investigator Site
Vandœuvre-lès-Nancy
Canada5 sites
Novartis Investigator Site
Halifax
Novartis Investigator Site
London
Novartis Investigator Site
Mississauga
Novartis Investigator Site
Montreal
Novartis Investigator Site
Ste-Foy
Hungary5 sites
Novartis Investigator Site
Debrecen
Novartis Investigator Site
Nyíregyháza
Novartis Investigator Site
Sopron
Novartis Investigator Site
Szombathely
Novartis Investigator Site
Tatabánya
Slovakia5 sites
Novartis Investigator Site
Bardejov
Novartis Investigator Site
Bratislava
Novartis Investigator Site
Košice
Novartis Investigator Site
Nitra
Novartis Investigator Site
Trenčín
Argentina4 sites
Novartis Investigator Site
Buenos Aires
Novartis Investigator Site
Córdoba
Novartis Investigator Site
Rosario
Novartis Investigator Site
San Miguel de Tucumán
Turkey (Türkiye)4 sites
Novartis Investigator Site
Ankara
Novartis Investigative Site
Istanbul
Novartis Investigator Site
Istanbul
Novartis Investigator Site
Izmir
Czechia3 sites
Novartis Investigator Site
Brno
Novartis Investigative Site
Prague
Novartis Investigator Site
Prague
About this study
Official title: 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.
- Conditions
- Asthma
- Being tested
- Indacaterol 300 μg, Salmeterol 50 μg, Placebo to indacaterol, Placebo to salmeterol
- Keywords
- asthma, QAB149, indacaterol
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indacaterol 300 μgDrug
Indacaterol was supplied as powder filled capsules together with a single dose dry powder inhaler (SDDPI).
Salmeterol 50 μgDrug
Salmeterol was supplied as powder filled capsules together with the manufacturer's proprietary dry powder inhalation device.
Placebo to indacaterolDrug
Placebo to indacaterol was supplied as powder filled capsules together with a single dose dry powder inhaler (SDDPI).
Placebo to salmeterolDrug
Placebo to salmeterol was supplied as powder filled capsules together with the manufacturer's proprietary dry powder inhalation device.
| Study group | Role | What they receive |
|---|---|---|
| Indacaterol 300 μg | Experimental | 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. Receives: Drug: Indacaterol 300 μg; Drug: Placebo to indacaterol; Drug: Placebo to salmeterol |
| Indacaterol 600 μg | Experimental | 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. Receives: Drug: Indacaterol 300 μg; Drug: Placebo to salmeterol |
| Salmeterol 50 μg | Active comparator | 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. Receives: Drug: Salmeterol 50 μg; Drug: Placebo to indacaterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With at Least 1 Adverse Event During the 26 Weeks of the Study
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.
Measured: Baseline (Day 1) to end of study (Week 26)
Systolic Blood Pressure 1 Hour Post-dose at 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.
Measured: Day 1
Systolic Blood Pressure 1 Hour Post-dose at 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.
Measured: Week 12
Diastolic Blood Pressure 1 Hour Post-dose at 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.
Measured: Day 1
Diastolic Blood Pressure 1 Hour Post-dose at 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.
Measured: Week 12
Corrected QT (QTc) Interval Using Fridericia's Formula Measured 1 Hour Post-dose at 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.
Measured: Day 1
Corrected QT (QTc) Interval Using Fridericia's Formula Measured 1 Hour Post-dose at 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.
Measured: Week 12
Corrected QT (QTc) Interval Using Fridericia's Formula Measured 1 Hour Post-dose at 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.
Measured: Week 21
24 Hour Mean Heart Rate Determined From ECG Holter Monitoring at 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.
Measured: Week 12
24 Hour Mean Heart Rate Determined From ECG Holter Monitoring at 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.
Measured: Week 26
Serum Potassium 1 Hour Post-dose at 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.
Measured: Day 1
Serum Potassium 1 Hour Post-dose at 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.
Measured: Week 12
Blood Glucose 1 Hour Post-dose at 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.
Measured: Day 1
Blood Glucose 1 Hour Post-dose at 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.
Measured: Week 12
Percentage of Patients With Clinically Significant Asthma Exacerbations During the 26 Weeks of the Study
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.
Measured: Baseline (Day 1) to end of study (Week 26)
Secondary outcomes (2)
Trough Forced Expiratory Volume in 1 Second (FEV1) 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.
Measured: 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
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.
Measured: Baseline (Day 1) to end of study (Week 26)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 805 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study chair, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00529529
- Sponsor's protocol ID
- CQAB149B2338
- Status last verified
- Aug 2011
- First submitted
- 12 Sep 2007
- Last updated
- 29 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00529529
- Acronym / sponsor ID
- CQAB149B2338
- Conditions
- Asthma
- Keywords
- asthma, QAB149, indacaterol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 805 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 14 Sep 2007 (estimated)
- Results
- Posted 19 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Indacaterol 300 μg | Experimental | Drug: Indacaterol 300 μg, Drug: Placebo to indacaterol, Drug: Placebo to salmeterolPatients 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. |
| Indacaterol 600 μg | Experimental | Drug: Indacaterol 300 μg, Drug: Placebo to salmeterolPatients 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. |
| Salmeterol 50 μg | Active comparator | Drug: Salmeterol 50 μg, Drug: Placebo to indacaterolPatients 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- 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:
Key exclusion criteria (9 listed)
- 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.
- 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.
- Patients who suffer from chronic obstructive pulmonary disease (COPD) as diagnosed by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (2006).
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indacaterol 300 μgIndacaterol was supplied as powder filled capsules together with a single dose dry powder inhaler (SDDPI). | Drug | Indacaterol 300 μg, Indacaterol 600 μg |
| Salmeterol 50 μgSalmeterol was supplied as powder filled capsules together with the manufacturer's proprietary dry powder inhalation device. | Drug | Salmeterol 50 μg |
| Placebo to indacaterolPlacebo to indacaterol was supplied as powder filled capsules together with a single dose dry powder inhaler (SDDPI). | Drug | Indacaterol 300 μg, Salmeterol 50 μg |
| Placebo to salmeterolPlacebo to salmeterol was supplied as powder filled capsules together with the manufacturer's proprietary dry powder inhalation device. | Drug | Indacaterol 300 μg, Indacaterol 600 μg |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
2 secondary outcomes
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
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study chair
Novartis Pharmaceuticals
126 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Indacaterol 300 μg and Salmeterol 50 μg in people with Asthma, run by Novartis Pharmaceuticals at 126 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 126 sites in United States, Germany, Spain, Italy, France and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2011.