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

NCT ID: NCT00529529

Last Updated: 2011-08-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

805 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Indacaterol 300 μg

Intervention Type DRUG

Indacaterol was supplied as powder filled capsules together with a single dose dry powder inhaler (SDDPI).

Placebo to indacaterol

Intervention Type DRUG

Placebo to indacaterol was supplied as powder filled capsules together with a single dose dry powder inhaler (SDDPI).

Placebo to salmeterol

Intervention Type DRUG

Placebo to salmeterol was supplied as powder filled capsules together with the manufacturer's proprietary dry powder inhalation device.

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.

Group Type EXPERIMENTAL

Indacaterol 300 μg

Intervention Type DRUG

Indacaterol was supplied as powder filled capsules together with a single dose dry powder inhaler (SDDPI).

Placebo to salmeterol

Intervention Type DRUG

Placebo to salmeterol was supplied as powder filled capsules together with the manufacturer's proprietary dry powder inhalation device.

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.

Group Type ACTIVE_COMPARATOR

Salmeterol 50 μg

Intervention Type DRUG

Salmeterol was supplied as powder filled capsules together with the manufacturer's proprietary dry powder inhalation device.

Placebo to indacaterol

Intervention Type DRUG

Placebo to indacaterol was supplied as powder filled capsules together with a single dose dry powder inhaler (SDDPI).

Interventions

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Indacaterol 300 μg

Indacaterol was supplied as powder filled capsules together with a single dose dry powder inhaler (SDDPI).

Intervention Type DRUG

Salmeterol 50 μg

Salmeterol was supplied as powder filled capsules together with the manufacturer's proprietary dry powder inhalation device.

Intervention Type DRUG

Placebo to indacaterol

Placebo to indacaterol was supplied as powder filled capsules together with a single dose dry powder inhaler (SDDPI).

Intervention Type DRUG

Placebo to salmeterol

Placebo to salmeterol was supplied as powder filled capsules together with the manufacturer's proprietary dry powder inhalation device.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_CHAIR

Novartis Pharmaceuticals

Locations

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Novartis Investigator Site

Glendale, Arizona, United States

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Phoenix, Arizona, United States

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Encinitas, California, United States

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Huntington Beach, California, United States

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Long Beach, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Oakland, California, United States

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Orange, California, United States

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Palmdale, California, United States

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San Diego, California, United States

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San Diego, California, United States

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Walnut Creek, California, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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Englewood, Colorado, United States

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Lakewood, Colorado, United States

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Brandon, Florida, United States

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Largo, Florida, United States

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Miami, Florida, United States

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Panama City, Florida, United States

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Pensacola, Florida, United States

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Pensacola, Florida, United States

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Tamarac, Florida, United States

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Albany, Georgia, United States

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Stockbridge, Georgia, United States

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Overland Park, Kansas, United States

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Overland Park, Kansas, United States

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Topeka, Kansas, United States

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Florence, Kentucky, United States

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Baltimore, Maryland, United States

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Wheaton, Maryland, United States

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North Dartmouth, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Ypsilanti, Michigan, United States

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Springfield, Missouri, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Omaha, Nebraska, United States

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Northfield, New Jersey, United States

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Rockville Centre, New York, United States

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Charlotte, North Carolina, United States

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High Point, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Toledo, Ohio, United States

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Edmond, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Greenville, South Carolina, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Kirkland, Washington, United States

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Seattle, Washington, United States

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Buenos Aires, , Argentina

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Córdoba, , Argentina

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Rosario, , Argentina

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San Miguel de Tucumán, , Argentina

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Halifax, , Canada

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London, , Canada

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Mississauga, , Canada

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Montreal, , Canada

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Ste-Foy, , Canada

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Brno, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Brest, , France

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Castelnau-le-Lez, , France

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Chauny, , France

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Paris, , France

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Tarbes, , France

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Vandœuvre-lès-Nancy, , France

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Berlin, , Germany

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Bochum, , Germany

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Borstel, , Germany

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Geesthacht, , Germany

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Hamburg, , Germany

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Kiel, , Germany

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Leipzig, , Germany

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Lübeck, , Germany

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Mainz, , Germany

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Marburg, , Germany

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Neumünster, , Germany

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Neuss, , Germany

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Schwetzingen, , Germany

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Wiesloch, , Germany

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Wittem, , Germany

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Debrecen, , Hungary

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Nyíregyháza, , Hungary

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Sopron, , Hungary

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Szombathely, , Hungary

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Tatabánya, , Hungary

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Brescia, , Italy

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Catania, , Italy

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Modena, , Italy

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Parma, , Italy

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Pietra Ligure, , Italy

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Pisa, , Italy

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Terni, , Italy

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Torino, , Italy

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Trieste, , Italy

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Lima, , Peru

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Bardejov, , Slovakia

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Bratislava, , Slovakia

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Košice, , Slovakia

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Nitra, , Slovakia

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Trenčín, , Slovakia

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Alicante, , Spain

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Barcelona, , Spain

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Begonte, , Spain

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Cadiz, , Spain

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Cáceres, , Spain

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Granollers, , Spain

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Hostalets de Balenyà, , Spain

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Illescas, , Spain

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L'Hospitalet de Llobregat, , Spain

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Mataró, , Spain

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Oviedo, , Spain

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Seville, , Spain

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Valencia, , Spain

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Ankara, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Countries

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United States Argentina Canada Czechia France Germany Hungary Italy Peru Slovakia Spain Turkey (Türkiye)

Other Identifiers

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CQAB149B2338

Identifier Type: -

Identifier Source: org_study_id

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