Clinical trial NCT00556673: Bronchodilatory Efficacy of a Single Dose QMF149 (Indacaterol Maleate/Mometasone Furoate) Via the Twisthaler® Device in Adult Patients With Asthma
Official title: An Exploratory, Multi-centre, Double-blind, Placebocontrolled Crossover Study, to Investigate the Bronchodilatory Efficacy of a Single Dose of Indacaterol in Fixed Combination With Mometasone Furoate Delivered Via a MDDPI (Twisthaler®) in Adult Patients With Persistent Asthma Using Open Label Seretide® Accuhaler® (50/250 Mcg b.i.d.) as an Active Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma, QMF149, fixed combination of indacaterol and mometasone furoate
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2007-11-12
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Change From Period Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).
Secondary outcomes:
measure: Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)
timeFrame: Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.
measure: Change From Period Baseline in Trough Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).
measure: Change From Period Baseline in Peak Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.
measure: Change From Period Baseline in Trough Forced Vital Capacity (FVC)
timeFrame: Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).
measure: Change From Period Baseline in Peak Forced Vital Capacity (FVC)
timeFrame: Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.
measure: Change From Period Baseline in Trough FEV1/FVC Ratio
timeFrame: Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).
measure: Change From Period Baseline in Peak FEV1/FVC Ratio
timeFrame: Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.
measure: Area Under the Concentration-time Curve From Time 0 to 12 Hours Post-dose for Mometasone Furoate
timeFrame: Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, and 12 hours post-dose.
measure: Area Under the Concentration-time Curve From Time 0 to 24 Hours Post-dose for Mometasone Furoate
timeFrame: Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.
measure: Area Under the Concentration-time Curve From Time 0 to 24 Hours Post-dose for Indacaterol
timeFrame: Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.
measure: Maximum (Peak) Plasma Concentration (Cmax) of Mometasone Furoate
timeFrame: Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.
measure: Maximum (Peak) Plasma Concentration (Cmax) of Indacaterol
timeFrame: Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.
measure: Time to Reach Peak or Maximum Concentration Following Drug Administration for Mometasone Furoate
timeFrame: Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.
measure: Time to Reach Peak or Maximum Concentration Following Drug Administration for Indacaterol
timeFrame: Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Novartis Investigator Site
city: Berlin
country: Germany
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis investigator site
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References: