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

Novartis

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: fluticasone proprionate / salmeterol xinafoate; Drug: placebo to indacaterol maleate/mometasone furoate; Drug: indacaterol maleate/mometasone furoate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00556673

2007-002360-10 (EudraCT Number)

CQMF149A2204

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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31 participants in 2 patient groups

Indacaterol/mometasone - Placebo

Experimental group

Description:

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.

Treatment:

Drug: indacaterol maleate/mometasone furoate

Drug: placebo to indacaterol maleate/mometasone furoate

Drug: fluticasone proprionate / salmeterol xinafoate

Placebo - indacaterol/mometasone

Experimental group

Description:

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.

Treatment:

Drug: indacaterol maleate/mometasone furoate

Drug: placebo to indacaterol maleate/mometasone furoate

Drug: fluticasone proprionate / salmeterol xinafoate