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 / mometasone furoate
Product Code: QMF149
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: IN
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with a documented diagnosis of asthma for a period of at least 3 months prior to Screening Visit - Patients who have used low dose ICS , with or without controller (ie, LABA, Leukotriene Receptor Antagonist ) at stable dose for at least 1 month prior to Screening Visit -Adult patients who are symptomatic despite treatment with existing therapy. Patients with ACQ-7 score = 1.5 at Visit 101 and at Visit 102 (inadequately controlled). - Adolescent patients : If taking only ICS (without LABA) and are symptomatic at screening despite treatment with low doses of ICS. These patients must have ACQ-7 score = 1.5 at Visit 101 and at Visit 102 . If taking ICS (low dose)/ LABA, and have ACQ-7 score =1 and =65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
Exclusion criteria: - Patients who have smoked or inhaled tobacco products (including electronic cigarettes) within the 6 month period prior to Visit 1, or who have a smoking history of greater than or equal to 10 pack year. - Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization (> 24 hours) or emergency room visit (= 24 hours) as follows: For adults: within 6 weeks of Screening Visit. If patients experience an asthma attack/exacerbation requiring systemic steroids or emergency room visit between Visit 1 and Visit 102 they may be re-screened 6 weeks after recovery from the exacerbation For adolescents: Severe asthma attack/exacerbation requiring systemic corticosteroid in the last 6 months or hospitalization (> 24 hours) due to severe asthma attack/exacerbation requiring systemic corticosteroids in the last 6 months or emergency room visit (=24 hours) due to severe asthma attack/exacerbation requiring systemic corticosteroids within the last 6 months.. - Patients who ever required intubation for a severe asthma attack/exacerbation - Patients with a clinical condition (eg. glaucoma, cataract and fragility fractures) which may be worsened by ICS administration (according to investigator's medical judgment ) - Patients who have had a respiratory tract infection or asthma worsening within 4 weeks prior to Screening Visit or between Visit 1and Visit 102. Patients may be re-screened 4 weeks after recovery from their respiratory tract infection or asthma worsening. - Patients with any chronic conditions affecting the upper respiratory tract (eg.chronic sinusitis) which in the opinion of the investigator may interfere with the study. - Patients with a history of chronic lung diseases other than asthma, including (but not limited to) COPD, sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis. - Patients with Type I diabetes or uncontrolled Type II diabetes. - Patients with narcolepsy and/or insomnia. - Patients on Maintenance Immunotherapy (desensitization) for allergies or less than 3 months prior to Visit 101 or patients on Maintenance Immunotherapy for more than 3 months prior to Visit 101 but expected to change throughout the course of the study. - Patients with diagnosed rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption or with known intolerance to lactose or milk products.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The key secondary objective of this study is to demonstrate the superiority of QMF149 150/80 microgram to MF 200 microgram o.d. in terms of ACQ-7 after 12 weeks of treatment. ;Timepoint(s) of evaluation of this end point: week 12; Main Objective: The primary objective of this study is to demonstrate the superiority of QMF149 150/80 microgram o.d. (in the evening) delivered via Concept1 compared with MF 200 microgram o.d. (in the evening) delivered via Twisthaler® in terms of trough FEV1 after 12 weeks of treatment in adults and adolescents. ; Primary end point(s): - To demonstrate the superiority of QMF149 150/80 microgram o.d. (in the evening) delivered via Concept1 compared with MF 200 microgram o.d. (in the evening) delivered via Twisthaler® in terms of trough FEV1 after 12 weeks of treatment in adults and adolescents. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - ACQ-7 after 4 weeks of treatment and after 12 weeks of treatment - Trough FEV1 at day - Pre-dose FEV1 at week 4 - FVC over 12 weeks - PEF over 4 and 12 weeks - Percentage of patients with MID at week 12 - Daily e-diary over 12 weeks - Rescue medication use over 12 weeks - Percentage of rescue medication free days over 12 weeks - Asthma exacerbation over 12 weeks - Quality of life assessed by AQLQ-S 12 - Composite endpoint of serious asthma outcomes ;Timepoint(s) of evaluation of this end point: Time points for each secondary endpoint is included in section E 5.2 | — |
Countries
Argentina, Bulgaria, Chile, Colombia, Estonia, Germany, Hungary, India, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Malaysia, Peru, Philippines, Poland, Romania, Russian Federation, Slovakia, South Africa, Sweden, Thailand, Vietnam
Contacts
Public ContactClinical Trial Information Desk
SIA Novartis Baltics Lithuanian Branch
Outcome results
None listed