Safety and Efficacy study of QVM149 in asthmatic patients
- Conditions
- Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]AsthmaMedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
- Registration Number
- EUCTR2015-002899-25-IT
- Lead Sponsor
- OVARTIS PHARMA SERVICES AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 3092
- Patients with a diagnosis of asthma, (GINA 2015) for a period of atleast 1 year prior to Visit 1 (Screening).
- Patients who have used medium or high dose of ICS/LABAcombinations for asthma for at least 3 months and at stable medium orhigh doses of ICS/LABA for at least 1 month prior to Visit 1. Patientsmust be symptomatic at screening despite treatment with mid or highstable doses of ICS/LABA.
- Patients with ACQ-7 score = 1.5 at Visit 101 and at Visit 102 (beforerandomization) (GINA 2015).
- Patients with documented history of at least one asthma exacerbationwhich required medical carefrom a physician, ER visit (or local equivalent structure) orhospitalization in the 12 months prior to Visit 1, and required systemiccorticosteroid treatment.
-Pre-bronchodilator FEV1 of < 80 % of the predicted normal value forthe patient according to ATS/ERS guidelines after withholdingbronchodilators at both visits 101 and 102.
-Withholding period of bronchodilators prior to spirometry: SABA for = 6hrs, Twice daily LABA (or FDC of ICS/LABA) for = 12 hrs, Once daily
LABA (or FDC of ICS/LABA) for = 24 hrs, SAMA for = 8 hrs, Short actingxanthines for 12 hrs, Long acting xanthines for 24 hrs.
- Washout period of each drug should be kept as close as possible asabove and should not be longer. If longer washout period is needed dueto scheduling issues, please contact Novartis Medical monitor.
- A one time repeat of percentage predicted FEV1 (Pre-bronchodilator)at visit 101 and/or 102 is allowed in an ad-hoc visit. Repeat of visit 101spirometry should be done in an ad-hoc visit to be scheduled on a datethat would provide sufficient time to receive confirmation from thespirometry data central reviewer of the validity of the assessment before
randomization. Run-in medication should be dispensed once spirometryassessment met inclusion criteria (ATS/ERS quality criteria, FEV1 %predicted normal value, and reversibility) as per equipment.
- A one-time rescreen is allowed in case the patient fails to meet thecriteria at the repeat, provided the patient returned to the requiredtreatment as per inclusion criteria 4
-Patients who demonstrate an increase in FEV1 of 12% and 200 mLwithin 30 minutes after administration of 400 µg salbutamol/360 µgalbuterol (or equivalent dose) at Visit 101.All patients must perform areversibility test at Visit 101. If reversibility is not demonstrated at Visit101 then one of the following criteria need to be met.
-Reversibility should be repeated once.
-Patients may be permitted to enter the study with historical evidence ofreversibility that was performed according to ATS/ERS guidelines within
2 years prior to Visit 1.
-Alternatively, patients may be permitted to enter the study with ahistorical positive broncho provocation test that was performed within 2years prior to Visit 1. If reversibility is not demonstrated at Visit 101 (orafter repeated assessment in an ad-hoc visit) and historical evidence ofreversibility/bronchoprovocation is not available (or was not performed according to theATS/ERS guidelines patients must be screen failed
- Spacer devices are permitted during reversibility testing only. TheInvestigator or delegate may decide whether or not to use a spacer forthe reversibility testing
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2997
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 158
- Patients who have had an asthma attack/exacerbation requiringsystemic steroids or hospitalization or emergency room visit within 6weeks of Visit 1 (Screening). If patients experience an asthmaattack/exacerbation requiring systemic steroids or hospitalization oremergency room visit between Visit 1 and Visit 102 they may be rescreened6 weeks after recovery from the exacerbation.
- Patients who have ever required intubation for a severe asthmaattack/exacerbation.
- Patients who have a clinical condition which is likely to be worsened byICS administration (e.g. glaucoma, cataract and fragility fractures) whoare according to investigator's medicaljudgment at risk participating inthe study.
- Patients treated with a LAMA for asthma within 3 months prior Visit 1(Screening).
- Patients with narrow-angle glaucoma, symptomatic benign prostatichyperplasia (BPH) or bladder-neck obstruction or severe renalimpairment or urinary retention. BPH patients who are stable ontreatment can be considered).
- Patients who have had a respiratory tract infection or asthmaworsening as determined by investigator within 4 weeks prior to Visit 1(Screening) or between Visit 1 and Visit 102. Patients may be rescreened4 weeks after recovery from their respiratory tract infection orasthma worsening.
- Patients with evidence upon visual inspection (laboratory culture is notrequired) of clinically significant (in the opinion of investigator)oropharyngeal candidiasis at Visit 102 or earlier, with or withouttreatment. Patients may be rescreened once their candidiasis has beentreated and has resolved.
- Patients with any chronic conditions affecting the upper respiratorytract (e.g. chronic sinusitis) which in the opinion of the investigator mayinterfere with the study evaluation or optimal participation in the study.
- Patients with a history of chronic lung diseases other than asthma,including (but not limited to) chronic obstructive pulmonary disease,sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significantbronchiectasis and active tuberculosis.
- Patients with Type I diabetes or uncontrolled Type II diabetes. -Patients who, either in the judgment of theinvestigator or the responsible Novartis personnel, have a clinicallysignificant condition such as (but not limited to) unstable ischemic heartdisease, New York Heart Association (NYHA) Class III/IV left ventricularfailure arrhythmia, uncontrolled hypertension, cerebrovascular disease,psychiatric disease, neurodegenerative diseases, or other neurologicaldisease, uncontrolled hypo- and hyperthyroidism and other autoimmune
diseases, hypokalemia, hyperadrenergic state, or ophthalmologicdisorder or patients with amedical condition that might compromise patient safety or compliance,interfere with evaluation, or preclude completion of the study.
- Patients with paroxysmal (e.g., intermittent) atrial fibrillation areexcluded. Patients with persistent atrial fibrillation as defined bycontinuous atrial fibrillation for at least 6 months and controlled with arate control strategy (i.e., selective beta blockers, calcium channelblocker, pacemaker placement, digoxin or ablationtherapy) for at least 6 months may be considered for inclusion. In such patients, atrial fibrillation must be present at the run-in visit (Visit 101)with a resting ventricular rate < 100/min. At Visit 101 the atrial
fibrillation must be confirmed by central reading.
- Patients with a history of myocardial infarction within the previous 12m
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method