A randomized, multi-center, parallel group, double blind, study to assess the safety of QMF Twisthaler® (500/400µg) and mometasone furoate Twisthaler® (400µg) in adolescent and adult patients with persistent asthma.
- Conditions
- -J45J45
- Registration Number
- PER-121-09
- Lead Sponsor
- OVARTIS BIOSCIENSES PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 98
• Patients must give written informed consent before any study related activity is performed Patients below the legal age of consent are required to have the Informed Consent Form signed by the patient’s parent/guardian; adolescents should also sign an assent form
• Male and female adult and adolescent patients aged =12 years (or =18 years depending upon regulatory and/or IRB/IEC/REB approval and/or country participation) and = 70 years
• Patients with a documented diagnosis of persistent asthma (according to GINA guidelines) for a period of at least 6 months prior to Visit 1 and who are currently treated with or qualify for treatment (according to asthma treatment guidelines) with both ICS and LABA combination.
• Patients demonstrating an increase in FEV1 of =12% or =200 mLs within 30 minutes after administration of ß2-agonist (SABA) as per site protocol. Alternatively, patients may have documentation of reversibility within the last 12 months
• Patients with an FEV1 =50% of predicted normal at Visit 2. This criterion for FEV1 will have to be demonstrated after all restricted medications have been withheld for appropriate intervals (washout period of at least 6 hours for a short acting ß2-agonist and a minimum of 24 hours for a long acting ß2-agonist).
• Pregnant or nursing (lactating) women confirmed by a positive serum hCG laboratory test (> 5 IU/ml)
• Women of child-bearing potential (WOCBP), including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal
• Patients who have smoked or inhaled tobacco products within the 3 month period prior to Visit 2, or who have a smoking history of greater than 10 pack years
• Patients with a previous diagnosis of COPD
• Patients who have had a asthma attack/exacerbation requiring hospitalization within 1 month prior to Visit 3
• Patients who have had an emergency room visit for an asthma attack/asthma exacerbation within 1 month prior to Visit 3
• Patients who have had a respiratory tract infection or asthma worsening within 1 month prior to Visit 3.
• Patients who have ever required ventilator support for respiratory failure secondary to asthma
• Patients with evidence upon visual inspection of clinically significant oropharyngeal candidiasis at baseline or earlier, with or without treatment.
• Patients with any chronic conditions affecting the respiratory tract or chronic lung diseases which may interfere with the study evaluation or optimal participation in the study
• Patients with diabetes Type I or uncontrolled diabetes Type II
• Patients who have a clinically relevant laboratory abnormality or a clinically significant condition that might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study
• Any patient with active cancer or a history of cancer with less than 5 years disease free survival time
• Patients with a history of long QT syndrome or whose QTc interval (Fridericia) measured at Visit 2 or Visit 3 is prolonged: >450 ms as assessed by the central ECG interpretation (Visit 2) or investigator’s interpretation of the pre-dose ECGs (Visit 3). Patients who fail the screening ECG (with the exception of machine failures) should not be re-screened.
• History of myocardial infarction within the previous 12 months; uncontrolled or unstable angina pectoris or arrhythmia (excluding chronic atrial fibrillation). Known history of congestive heart failure or known LVEF < 45%. Implanted cardiac pacemaker or defibrillator
• Patients with a history of hypersensitivity to any of the study drugs or to similar drugs within the class including untoward reactions to sympathomimetic amines or inhaled medication or any component thereof.
• Patients who do not maintain regular day/night, waking/sleeping cycles
• Patients who have had live attenuated vaccinations within 30 days prior to screening visit or during the run-in period.
• Patients using prohibited medications or patients who cannot adhere to medication washouts.
• Maintenance Immunotherapy (desensitization) for allergies is allowed if maintenance dose has been administered for at least 3 months prior to Visit 2, and is expected to remain unchanged throughout the course of the study
• Other excluded medications
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Defined as the number of days from start of treatment up to the first date when an asthma exacerbation becomes serious. A serious asthma exacerbation was one that resulted in hospitalization, intubation or death.<br><br>Measure:Time to First Serious Asthma Exacerbation<br>Timepoints:Up to 21 months<br>
- Secondary Outcome Measures
Name Time Method