None listed
Conditions
Interventions
QVM149 is an orally inhaled once-daily fixed-dose combination of indacaterol acetate a long-acting β
2-agonist (LABA), glycopyrronium bromide a long-acting muscarinic antagonist (LAMA), and MF an inhaled corticosteroid (ICS). The LABA/LAMA/ICS fixed-dose combination (FDC) product is in development as
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female adult patient ≥ 18 years old and ≤ 75 years. 2. Written informed consent must be obtained before any studyrelated assessment is performed. 3. Patients with a diagnosis of asthma, (GINA 2015 ≥ step 4) for a period of at least 1 year prior to Visit 1 (Screening). 4. Patients who have used ICS/LABA combinations (Appendix 10) for asthma for at least 1 year and at stable medium or high doses of ICS/LABA for at least 1 month prior to Visit 1. 5. Patients must be symptomatic at screening despite treatment with mid or high stable doses of ICS/LABA. Patients with ACQ-7 score ≥ 1.5 at Visit 101 and at Visit 102 (randomization visit) (GINA 2015 step≥ 4). 6. Patients with documented history of at least one asthma exacerbation which required medical care from a physician, ER visit (or local equivalent structure) or hospitalization in the 12 months prior to Visit 1 and required systemic corticosteroid treatment. Previous asthma exacerbation in this context is based on patient´s recall of unplanned need for medical care at any primary care physician, pulmonologist, emergency room and/or hospital due to an aggravation of asthma symptoms requiring treatment with systemic corticosteroids due to asthma exacerbation. Every effort should be made by the site to obtain/have appropriate source documentation for these previous asthma exacerbations. 7. Pre-bronchodilator FEV1 of < 80 % of the predicted normal value for the patient after withholding bronchodilators (Table 5- 2) at both visits 101 and 102.  Withholding period of bronchodilators prior to spirometry: SABA for ≥ 6 hrs. LABA (or fixed dose combination of ICS/LABA) for ≥ 24 hrs (48 hrs for indacaterol fixed dose combination (FDC)), SAMA for ≥ 8 hrs, xanthines ≥ 7 days.  Re-testing is allowed once only. Re-assessment of percentage predicted FEV1 should be done in an ad-hoc visit to be scheduled on a date that would provide sufficient time to receive confirmation from the spirometry data central reviewer of the validity of the assessment before randomization. Spacer devices are not permitted during reversibility testing.
Exclusion criteria
Exclusion criteria:  Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 6 weeks of Visit 1 (Screening).  Patients who have ever required intubation for a severe asthma attack/exacerbation  Patients who have a clinical condition which is likely to be worsened by ICS administration (e.g. glaucoma, cataract and fragility fractures) who are according to investigator´s medical judgment at risk participating in the study)  Patients treated with a LAMA for asthma within 12 months prior Visit 1 (Screening).  Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia (BPH) or bladder-neck obstruction or severe renal impairment or urinary retention. BPH patients who are stable on treatment can be considered).  Patients who have had a respiratory tract infection or asthma worsening according to the definition in Section 6.4.4 within 4 weeks prior to Visit 1 (Screening) or between Visit 1 and Visit 102. Patients may be re-screened 4 weeks after recovery from their respiratory tract infection or asthma worsening  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 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
Countries
Argentina, Germany
Contacts
Public ContactTatiana Vargas
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed