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

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Fluticasone; Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Maleic acid; Mometasone Furoate; Salmeterol Xinafoate

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

Other protocol-defined inclusion/exclusion criteria may apply.