Asthma MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: Indacaterol acetate/Glycopyrroniumbromide/mometasone furoate
Product Code: QVM149
Pharmaceutical Form: Inhalation powder
INN or Proposed I
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with a documented physician diagnosis of asthma and who additionally meet the following criteria: - Patients receiving daily treatment with an inhaled corticosteroid at a low or medium daily dose - On a stable regimen for at least 4 weeks prior to screening. - Pre-bronchodilator FEV1 = 60 % and =65 years) no F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: - Contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the drugs of a similar class - Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 1 year of Screening. - Patients who have had previous intubation for a severe asthma attack/exacerbation. - Patients with a history of clinically relevant bronchoconstriction upon repeated forced expiratory maneuvers. - History of paradoxical bronchospasm in response to inhaled medicines. - Patients who during the run-in period prior to randomization require the use of =12 puffs / 24 hours of rescue medication for 48 hours (over two consecutive days) or who have a decline in PEF from the reference PEF of = 30% for 6 consecutive scheduled PEF readings - Patients who do not maintain regular day/night, waking/sleeping cycles (e.g., night shift workers).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study is to assess the bronchodilator effects of QVM149 dosed once daily either in the morning or in the evening for 2 weeks compared to placebo. ; Secondary Objective: - FEV1 after 24h at the end of each treatment period day 14 pre-dose to 24 hours post-dose - Peak expiratory flow from treatment period start through study completion ;Primary end point(s): FEV1 over 24 h (AUC0-24h) ;Timepoint(s) of evaluation of this end point: Over 24 h (AUC0-24h) following 14 days of treatment with QVM149 dosed in the morning, QVM149 dosed in the evening and placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - FEV1 after 24h - Peak expiratory Flow ; Timepoint(s) of evaluation of this end point: • FEV1 at approximately 24 h after the last p.m. or second last a.m. dose. • PEF: Daily morning and evening peak expiratory flow rate from Day 2 to Day 14 during the three treatment periods | — |
Countries
Germany, Netherlands, United Kingdom
Contacts
Public ContactMedizinischer Infoservice (MCC)
Novartis Pharma GmbH
Outcome results
None listed