A Randomized, Double-blind, Double-dummy, 4-week Treatment, Parallel-group Study to Evaluate the Efficacy and Safety of Two Doses of Mometasone Furoate Delivered Via Concept1 or Twisthaler® in Adult and Adolescent Patients With Persistent Asthma
Overview
- Phase
- Phase 2
- Intervention
- Twisthaler
- Conditions
- Asthma
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 739
- Locations
- 1
- Primary Endpoint
- Trough Forced Expiratory Volume in 1 Second (FEV1)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The purpose of this study is to compare the efficacy, safety and pharmacokinetics of Mometasone furoate delivered via Concept1 device or Twisthaler® device in adult and adolescent patients with persistent asthma.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males or females who were ≥ 12 years old at the time informed consent was obtained
- •Patients with persistent asthma, diagnosed according to GINA 2010 guideline and who additionally met the following criteria
- •Patients who were receiving ICS treatment up to the maximum dose per day as indicated in the corresponding package leaflet and also a stable ICS regimen for at least 4 weeks prior to screening (Visit 2).
- •Patients whose level of asthma control according to GINA 2010 guideline was "Partly Controlled" or "Uncontrolled" at screening (Visit 2).
- •Patients with a pre-bronchodilator FEV1 value of ≤ 80% of predicted normal value at screening (Visit 2).
- •Patients who demonstrated an increase of ≥ 12% and 200 mL in FEV1 over prebronchodilator value within 30 minutes after inhalation of 400 μg of salbutamol (360 μg of albuterol) at Visit 2 or between Visit 2 and Visit
- •Patients who were confirmed as "ICS sensitive" by ACQ-5 and FEV1 at Visit
- •Key exclusion criteria included:
- •Patients diagnosed with COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease, updated
- •Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest X-ray to be no longer active), or clinically significant bronchiectasis.
Exclusion Criteria
- Not provided
Arms & Interventions
Mometasone furoate 800 µg
Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 800 ug delivered via the Twisthaler® device for 4 weeks.
Intervention: Twisthaler
Mometasone furoate 80 μg
Description: Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 80 ug delivered via the Concept1 device for 4 weeks.
Intervention: Mometasone furoate
Mometasone furoate 80 μg
Description: Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 80 ug delivered via the Concept1 device for 4 weeks.
Intervention: Concept 1
Mometasone furoate 200 µg
Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 200 ug delivered via the Twisthaler® device for 4 weeks.
Intervention: Mometasone furoate
Mometasone furoate 200 µg
Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 200 ug delivered via the Twisthaler® device for 4 weeks.
Intervention: Twisthaler
Mometasone furoate 320 µg
Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 320 ug delivered via the Concept1 device for 4 weeks.
Intervention: Mometasone furoate
Mometasone furoate 320 µg
Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 320 ug delivered via the Concept1 device for 4 weeks.
Intervention: Concept 1
Mometasone furoate 800 µg
Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 800 ug delivered via the Twisthaler® device for 4 weeks.
Intervention: Mometasone furoate
Outcomes
Primary Outcomes
Trough Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: Day 29
Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Measurements were taken on day 29 after treatment.
Secondary Outcomes
- Forced Vital Capacity (FVC) at All Time Points(Days 1, 8, 15, 22, 28 and 29 at all time points)
- Plasma Cortisol Concentrations(Baseline, days 1 and 28)
- Fractional Exhaled Nitric Oxide (FeNO)(Days 15 and 29)
- Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points(Days 1, 8, 15, 22, 28 and 29 at all time points)
- Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Over 4 Weeks of Treatment(Baseline and 4 weeks)
- Change From Baseline in Asthma Control Questionnaire (ACQ-5) by Visit(Baseline, days 8,15,22 and 29)
- Trough Forced Expiratory Volume in 1 Second (FEV1) After Days 8, 15 and 22 of Treatment(Days 8, 15 and 22)
- Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points(Days 1, 8, 15, 22, 28 and 29 at all time points)
- Change From Baseline in Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 4 Weeks of Treatment(Baseline and week 4)
- Percentage of Days With no Rescue Medication Use Over 4 Weeks of Treatment(4 weeks)