Clinical trial NCT00529529: Safety of Indacaterol in Patients (≥ 12 Years) With Moderate to Severe Persistent Asthma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: asthma
QAB149
indacaterol
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-09-14
Enrollment: 805
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Patients With at Least 1 Adverse Event During the 26 Weeks of the Study
timeFrame: Baseline (Day 1) to end of study (Week 26)
measure: Systolic Blood Pressure 1 Hour Post-dose at Day 1
timeFrame: Day 1
measure: Systolic Blood Pressure 1 Hour Post-dose at Week 12
timeFrame: Week 12
measure: Diastolic Blood Pressure 1 Hour Post-dose at Day 1
timeFrame: Day 1
measure: Diastolic Blood Pressure 1 Hour Post-dose at Week 12
timeFrame: Week 12
measure: Corrected QT (QTc) Interval Using Fridericia's Formula Measured 1 Hour Post-dose at Day 1
timeFrame: Day 1
measure: Corrected QT (QTc) Interval Using Fridericia's Formula Measured 1 Hour Post-dose at Week 12
timeFrame: Week 12
measure: Corrected QT (QTc) Interval Using Fridericia's Formula Measured 1 Hour Post-dose at Week 21
timeFrame: Week 21
measure: 24 Hour Mean Heart Rate Determined From ECG Holter Monitoring at Week 12
timeFrame: Week 12
measure: 24 Hour Mean Heart Rate Determined From ECG Holter Monitoring at Week 26
timeFrame: Week 26
measure: Serum Potassium 1 Hour Post-dose at Day 1
timeFrame: Day 1
measure: Serum Potassium 1 Hour Post-dose at Week 12
timeFrame: Week 12
measure: Blood Glucose 1 Hour Post-dose at Day 1
timeFrame: Day 1
measure: Blood Glucose 1 Hour Post-dose at Week 12
timeFrame: Week 12
measure: Percentage of Patients With Clinically Significant Asthma Exacerbations During the 26 Weeks of the Study
timeFrame: Baseline (Day 1) to end of study (Week 26)
Secondary outcomes:
measure: Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at Week 12 + 1 Day, Day 85
timeFrame: 24 hours post-dose at Week 12 + 1 day, Day 85
measure: Number of Asthma Exacerbations Per Patient (Without Imputation) During the 26 Weeks of the Study
timeFrame: Baseline (Day 1) to end of study (Week 26)
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Novartis Investigator Site
state: Arizona
city: Phoenix
country: United States
facility: Novartis Investigator Site
state: Arizona
city: Encinitas
country: United States
facility: Novartis Investigator Site
state: California
city: Huntington Beach
country: United States
facility: Novartis Investigator Site
state: California
city: Long Beach
country: United States
facility: Novartis Investigator Site
state: California
city: Long Beach
country: United States
facility: Novartis Investigator Site
state: California
city: los Angeles
country: United States
facility: Novartis Investigator Site
state: California
city: Oakland
country: United States
facility: Novartis Investigator Site x 2 sites
state: California
city: Orange
country: United States
facility: Novartis Investigator Site
state: California
city: Palmdale
country: United States
facility: Novartis Investigator Site
state: California
city: San diego
country: United States
facility: Novartis Investigator Site
state: California
city: San Diego
country: United States
facility: Novartis Investigator Site
state: California
city: Walnut Creek
country: United States
facility: Novartis Investigator Site
state: California
city: Denver
country: United States
facility: Novartis Investigator Site
state: Colorado
city: Denver
country: United States
facility: Novartis Investigator Site
state: Colorado
city: Englewood
country: United States
facility: Novartis Investigator Site
state: Colorado
city: Lakewood
country: United States
facility: Novartis Investigator Site
state: Colorado
city: Brandon
country: United States
facility: Novartis Investigator Site
state: Florida
city: Largo
country: United States
facility: Novartis Investigator Site
state: Florida
city: Miami
country: United States
facility: Novartis Investigator Site
state: Florida
city: Panama City
country: United States
facility: Novartis Investigator Site
state: Florida
city: Pensacola
country: United States
facility: Novartis Investigator Site
state: Florida
city: Pensacola
country: United States
facility: Novartis Investigator Site x 2 sites
state: Florida
city: Tamarac
country: United States
facility: Novartis Investigator Site
state: Florida
city: Albany
country: United States
facility: Novartis Investigator Site
state: Georgia
city: Stockbridge
country: United States
facility: Novartis Investigator Site
state: Georgia
city: overland Park
country: United States
facility: Novartis Investigator Site
state: Kansas
city: Overland Park
country: United States
facility: Novartis Investigator Site
state: Kansas
city: Topeka
country: United States
facility: Novartis Investigator Site
state: Kansas
city: Florence
country: United States
facility: Novartis Investigator Site
state: Kentucky
city: Baltimore
country: United States
facility: Novartis Investigator Site
state: Maryland
city: Wheaton
country: United States
facility: Novartis Investigator Site
state: Maryland
city: North Dartmouth
country: United States
facility: Novartis Investigator Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Novartis Investigator Site
state: Michigan
city: Ypsilanti
country: United States
facility: Novartis Investigator Site
state: Michigan
city: Springfield
country: United States
facility: Novartis Investigator Site
state: Missouri
city: St louis
country: United States
facility: Novartis Investigator Site
state: Missouri
city: Omaha
country: United States
facility: Novartis Investigator Site
state: Nebraska
city: Omaha
country: United States
facility: Novartis Investigator Site
state: Nebraska
city: Northfield
country: United States
facility: Novartis Investigator Site
state: New Jersey
city: Rockville Centre
country: United States
facility: Novartis Investigator Site
state: New York
city: Charlotte
country: United States
facility: Novartis Investigator Site
state: North Carolina
city: High Point
country: United States
facility: Novartis Investigator Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Novartis Investigator Site
state: North Carolina
city: Cincinnati
country: United States
facility: Novartis Investigator Site
state: Ohio
city: Toledo
country: United States
facility: Novartis Investigator Site
state: Ohio
city: Edmond
country: United States
facility: Novartis Investigator Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Novartis Investigator Site
state: Oklahoma
city: Greenville
country: United States
facility: Novartis Investigator Site
state: South Carolina
city: Dallas
country: United States
facility: Novartis Investigator Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigator site
state: Texas
city: Houston
country: United States
facility: Novartis Investigator Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigator Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigator Site
state: Texas
city: Kirkland
country: United States
facility: Novartis Investigator Site
state: Washington
city: Seattle
country: United States
facility: Novartis Investigator Site
state: Washington
city: Buenos Aires
country: Argentina
facility: Novartis Investigator Site
city: Cordoba
country: Argentina
facility: Novartis Investigator Site
city: Rosario
country: Argentina
facility: Novartis Investigator Site
city: San Miguel de Tucuman
country: Argentina
facility: Novartis Investigator Site
city: Halifax
country: Canada
facility: Novartis Investigator Site
city: London
country: Canada
facility: Novartis Investigator Site
city: Mississauga
country: Canada
facility: Novartis Investigator Site
city: Montreal
country: Canada
facility: Novartis Investigator Site
city: Ste-Foy
country: Canada
facility: Novartis Investigator Site
city: Brno
country: Czech Republic
facility: Novartis Investigator Site
city: Praha
country: Czech Republic
facility: Novartis Investigative Site
city: Praha
country: Czech Republic
facility: Novartis Investigator Site
city: Brest cedex
country: France
facility: Novartis Investigator Site
city: Castelnau-le-Lez
country: France
facility: Novartis Investigator Site
city: Chauny
country: France
facility: Novartis Investigator Site
city: Paris Cedex 14
country: France
facility: Novartis Investigator Site
city: Tarbes Cedex
country: France
facility: Novartis Investigator Site
city: Vandoeuvre Les Nancy
country: France
facility: Novartis Investigator Site
city: Berlin
country: Germany
facility: Novartis Investigator Site
city: Bochum
country: Germany
facility: Novartis Investigator Site
city: Borstel
country: Germany
facility: Novartis Investigator Site
city: Geesthacht
country: Germany
facility: Novartis Investigator Site
city: Hamburg
country: Germany
facility: Novartis Investigator Site
city: Kiel
country: Germany
facility: Novartis Investigator Site
city: Leipzig
country: Germany
facility: Novartis Investigator Site
city: Luebeck
country: Germany
facility: Novartis Investigator Site
city: Mainz
country: Germany
facility: Novartis Investigator Site
city: Marburg
country: Germany
facility: Novartis Investigator Site
city: Neumunster
country: Germany
facility: Novartis Investigator Site
city: Neuss
country: Germany
facility: Novartis Investigator Site
city: Schwetzingen
country: Germany
facility: Novartis Investigator Site
city: Wiesloch
country: Germany
facility: Novartis Investigator Site
city: Wittem
country: Germany
facility: Novartis Investigator Site
city: Debrecen
country: Hungary
facility: Novartis Investigator Site
city: Nyiregyhaza
country: Hungary
facility: Novartis Investigator Site
city: Sopron
country: Hungary
facility: Novartis Investigator Site
city: Szombathely
country: Hungary
facility: Novartis Investigator Site
city: Tatabanya
country: Hungary
facility: Novartis Investigator Site
city: Brescia
country: Italy
facility: Novartis Investigator Site
city: Catania
country: Italy
facility: Novartis Investigator Site
city: Modena
country: Italy
facility: Novartis Investigator Site
city: Parma
country: Italy
facility: Novartis Investigator Site
city: Pietra Ligure
country: Italy
facility: Novartis Investigator Site
city: Pisa
country: Italy
facility: Novartis Investigator Site
city: Terni
country: Italy
facility: Novartis Investigator Site
city: Torino
country: Italy
facility: Novartis Investigator Site
city: Trieste
country: Italy
facility: Novartis Investigator Site
city: Lima
country: Peru
facility: Novartis Investigator Site
city: Bardejov
country: Slovakia
facility: Novartis Investigator Site
city: Bratislava
country: Slovakia
facility: Novartis Investigator Site
city: Kosice
country: Slovakia
facility: Novartis Investigator Site
city: Nitra
country: Slovakia
facility: Novartis Investigator Site
city: Trencin
country: Slovakia
facility: Novartis Investigator Site
city: Alicante
country: Spain
facility: Novartis Investigator Site
city: Barcelona
country: Spain
facility: Novartis Investigator Site
city: Begonte
country: Spain
facility: Novartis Investigator Site
city: Caceres
country: Spain
facility: Novartis Investigator Site
city: Cádiz
country: Spain
facility: Novartis Investigator Site
city: Granollers
country: Spain
facility: Novartis Investigator Site
city: Hospitalet de Llobregat
country: Spain
facility: Novartis Investigative Site
city: Hostalets de Balenyà
country: Spain
facility: Novartis Investigator Site
city: Illescas
country: Spain
facility: Novartis Investigator Site
city: Mataró
country: Spain
facility: Novartis Investigator Site
city: Oviedo
country: Spain
facility: Novartis Investigator Site
city: Sevilla
country: Spain
facility: Novartis Investigator Site
city: Valencia
country: Spain
facility: Novartis Investigator Site
city: Ankara
country: Turkey
facility: Novartis Investigator Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigator Site
city: Izmir
country: Turkey
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References: