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

NCT00556673 | Completed Phase 2 Results

• 2 other identifiers: CQMF149A22042007-002360-10
• Study Type: interventional
• Target: 31
• Locations: 2 countries
• Sites: 2

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

Keywords

Asthma, QMF149, fixed combination of indacaterol and mometasone furoate

Outcome Measures

Primary Outcomes (1)

• Change From Period Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)

  FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from the period baseline to 24 hour post dose trough FEV1 after 1 day of treatment was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose FEV1 as covariate.

  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 (14)

• Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)

  Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.

• Change From Period Baseline in Trough Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)

  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).

• Change From Period Baseline in Peak Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)

  Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.

• Change From Period Baseline in Trough Forced Vital Capacity (FVC)

  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).

• Change From Period Baseline in Peak Forced Vital Capacity (FVC)

  Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.

Study Arms (2)

Indacaterol/mometasone - Placebo

EXPERIMENTAL

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.

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

Placebo - indacaterol/mometasone

EXPERIMENTAL

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.

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

Interventions

indacaterol maleate/mometasone furoate DRUG

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

Also known as: QMF149

Indacaterol/mometasone - Placebo; Placebo - indacaterol/mometasone

placebo to indacaterol maleate/mometasone furoate DRUG

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

Indacaterol/mometasone - Placebo; Placebo - indacaterol/mometasone

fluticasone proprionate / salmeterol xinafoate DRUG

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

Also known as: Seretide® Accuhaler®

Indacaterol/mometasone - Placebo; Placebo - indacaterol/mometasone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.
• 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.
• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

Novartis Investigator Site

Poitiers, 86000, France

Location

Novartis Investigator Site

Berlin, 14050, Germany

Location

MeSH Terms

Conditions

Asthma

Interventions

Mometasone Furoate; QMF149; Salmeterol Xinafoate

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis

  Novartis investigator site

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2007
• First Posted: November 12, 2007
• Study Start: October 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: April 22, 2013
• Results First Posted: April 22, 2013

Record last verified: 2013-03

Locations

FR (1); DE (1)