Bronchodilatory Efficacy of a Single Dose QMF149 (Indacaterol Maleate/Mometasone Furoate) Via the Twisthaler® Device in Adult Patients With Asthma

NCT ID: NCT00556673

Last Updated: 2013-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2008-04-30

Brief Summary

This study is designed to evaluate the bronchodilatory efficacy of indacaterol maleate 500 μg/mometasone furoate 400 μg via the Twisthaler® device in adult patients with persistent asthma.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Indacaterol/mometasone - Placebo

In Treatment Period 1 (Day 1) participants received 2 inhalations of indacaterol maleate 250 μg / mometasone furoate 200 μg once a day in the morning via the Twisthaler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of placebo via the Twisthaler device once a day in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg / salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days.

Group Type: EXPERIMENTAL

indacaterol maleate/mometasone furoate

Intervention Type: DRUG

Indacaterol maleate 250 μg / mometasone furoate 200 μg delivered via the Twisthaler device.

placebo to indacaterol maleate/mometasone furoate

Intervention Type: DRUG

Placebo to indacaterol maleate/mometasone furoate delivered via the Twisthaler device.

fluticasone proprionate / salmeterol xinafoate

Intervention Type: DRUG

Fluticasone proprionate 250 μg / salmeterol xinafoate 50 μg delivered via the Accuhaler® device.

Placebo - indacaterol/mometasone

In Treatment Period 1 (Day 1) participants received 2 inhalations of placebo in the morning via the Twistheler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of indacaterol maleate 250 μg / mometasone furoate 200 μg via the Twisthaler device in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg / salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days.

Group Type: EXPERIMENTAL

indacaterol maleate/mometasone furoate

Intervention Type: DRUG

Indacaterol maleate 250 μg / mometasone furoate 200 μg delivered via the Twisthaler device.

placebo to indacaterol maleate/mometasone furoate

Intervention Type: DRUG

Placebo to indacaterol maleate/mometasone furoate delivered via the Twisthaler device.

fluticasone proprionate / salmeterol xinafoate

Intervention Type: DRUG

Fluticasone proprionate 250 μg / salmeterol xinafoate 50 μg delivered via the Accuhaler® device.

Interventions

indacaterol maleate/mometasone furoate

Indacaterol maleate 250 μg / mometasone furoate 200 μg delivered via the Twisthaler device.

Intervention Type: DRUG

placebo to indacaterol maleate/mometasone furoate

Placebo to indacaterol maleate/mometasone furoate delivered via the Twisthaler device.

Intervention Type: DRUG

fluticasone proprionate / salmeterol xinafoate

Fluticasone proprionate 250 μg / salmeterol xinafoate 50 μg delivered via the Accuhaler® device.

Intervention Type: DRUG

Other Intervention Names

QMF149; Seretide® Accuhaler®

Eligibility Criteria

Inclusion Criteria

• Male and female adult patients aged 18-75 years with persistent asthma
• Patients with persistent asthma, diagnosed according to the Global Initiative for Asthma guidelines (GINA) and who additionally met the following criteria:

1. Patients receiving daily treatment with inhaled corticosteroid up to the maximum dose per day indicated in the package leaflet, in a stable regimen for the month prior to Visit 1.

2. Patients with a forced expiratory volume in 1 second (FEV1) at Visit 1 of ≥ 50% of the predicted normal value. This criterion for FEV1 had to be demonstrated after a washout period of at least 6 hours during which no short acting β2-agonist had been inhaled, and a minimum of 48 hours for a long acting β2-agonist.

3. Patients who demonstrated an increase of ≥12% and ≥200 mL in FEV1 over their pre-bronchodilator value 30 minutes after inhaling a total of 200 μg of salbutamol (or albuterol) via metered dose inhaler (MDI) (the reversibility test). Reversibility had to be demonstrated after an appropriate washout period of at least 6 hrs prior to the evaluation for a shortacting β2-agonist. The administration of salbutamol (or albuterol) for the reversibility test was to be within 30 minutes after pre-bronchodilator spirometry. Reversibility had to be demonstrated at Visit 1 or between Visits 1 and 2, in order for patients to be included in the trial.

4. For each patient, the smaller value of the Visit 1 FEV1 or the Visit 2 FEV1 pre-dose value had to be at least 85% of the larger value.

• Body mass index (BMI) between 18 and 32 kg/m^2 and weight >50 kg.
• patients using local contraception

Exclusion Criteria

• Pregnant or nursing women
• Recent use of tobacco or history of smoking > 10 pack years
• Patients diagnosed with chronic obstructive pulmonary disease (COPD)
• Patients with recent experience of severe asthma attack/exacerbation within 6-months of study start
• Patients with frequent rescue medication (>8 puffs/day for two consecutive days)
• Clinically relevant laboratory abnormality or a clinically significant condition
• Active cancer or a history of cancer with less than 5 years disease free survival time
• History of long QT syndrome or with long QTc interval prior to dosing
• History of hypersensitivity to the study drugs or to drugs with similar chemical structures
• Use of certain medications
• Use of other investigational drugs
• A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
• History of immunodeficiency diseases, including a positive human immumodeficiency virus (HIV) test result.
• History of drug or alcohol abuse or evidence of such abuse

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis

Role: PRINCIPAL_INVESTIGATOR

Novartis investigator site

Locations

Novartis Investigator Site

Poitiers, , France

Novartis Investigator Site

Berlin, , Germany

Countries

France; Germany

Other Identifiers

2007-002360-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CQMF149A2204

Identifier Type: -

Identifier Source: org_study_id