Health Condition 1: null- adult and adolescent patients with persistent asthma
Conditions
Interventions
Intervention1: Mometasone furoate delivered via Concept1(Inhaler), 80 μg o.d.: administered in the evening,
Route of administration: Nasal,
Treatment Duration: 4 weeks
Intervention2: Mometasone furo
Sponsors
Novartis Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Main Key Inclusion Criteria are as follows: • Patients with persistent asthma, diagnosed according to GINA 2010 guideline and who additionally meet the following criteria: • Patients who are receiving ICS treatment • Patients whose level of asthma control is "Partly Controlled" or "Uncontrolled" • Patients with a pre-bronchodilator FEV1 value of less than or equal to 80% of predicted normal value • Patients who demonstrate an increase of more than or equal to 12% and 200 mL in FEV1 • Patients who are confirmed as "ICS sensitive" by ACQ-5 questionnaire and FEV1 Other protocol-defined inclusion criteria are also applied.
Exclusion criteria
Exclusion criteria: Main Key Exclusion Criteria are as follows: • Patients who are current smokers or have a smoking history of greater than 10 pack years (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked). • Patients diagnosed with COPD as defined by the GOLD 2010 guidelines. • Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest X-ray to be no longer active), or clinically significant bronchiectasis. • Patients with any chronic conditions affecting the respiratory tract (e.g., chronic sinusitis) or chronic lung diseases, which in the opinion of the investigator may interfere with the study evaluation or optimal participation in the study. Other protocol-defined Exclusion criteria are also applied.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Trough Forced Expiratory Volume in one second (FEV1)Timepoint: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events, laboratory analysis, vital signs and ECGTimepoint: 4 weeks;Asthma Control Questionnaire 5 (ACQ-5)Timepoint: 1 week, 2 weeks, 3 weeks, 4 weeks;FeNO (Fractional exhaled Nitric Oxide)Timepoint: 2 weeks, 4 weeks;FEV1 at each time pointTimepoint: Day 1, Day 2, Day 8, Day 15, Day 22, Day 28, Day 29;Forced Expiratory Flow between 25% and 75% (FEF25-75%) at each time pointTimepoint: Day 1, Day 2, Day 8, Day 15, Day 22, Day 28, Day 29;Forced vital capacity (FVC) at each time pointTimepoint: Day 1, Day 2, Day 8, Day 15, Day 22, Day 28, Day 29;Plasma cortisol concentrations at each timepointTimepoint: Day 1, Day 2, Day 8, Day 15, Day 22, Day 28, Day 29;The usage of rescue medication (short acting β2-agonist)Timepoint: 4 weeks;Trough FEV1Timepoint: 1 week, 2 weeks, 3 weeks | — |
Countries
Belgium, Canada, Estonia, Germany, Hungary, India, Japan, Latvia, Lithuania, Malaysia, Netherlands, Poland, Russian Federation, Slovakia, Thailand, Turkey, Ukraine
Contacts
Public ContactSuchela Srivatsa
Quintiles Research India Pvt. Ltd
Outcome results
None listed