A Randomized, Double-blind, Active-controlled, Parallel Group, Stratified, Multi-center, 12-Week Study Comparing the Safety and Efficacy of Fluticasone and Formoterol Combination (FlutiForm™ 250/10mcg twice daily) in a Single Inhaler (SkyePharma HFA pMDI) with the Administration of Fluticasone (250mcg twice daily) Alone in SkyePharma HFA pMDI and Flovent® HFA pMDI in Adolescent and Adult Patients with Moderate to Severe Asthma.
- Conditions
- -J45J45
- Registration Number
- PER-011-08
- Lead Sponsor
- Skye Pharma AG,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Age of> 12 years in the Selection visit.
• History of asthma during> 12 months prior to the screening visit. For the purposes of this study, ´asma´ was defined by the NAEPP
• Documented use of an inhaled corticosteroid for a minimum of 4 weeks prior to the Screening visit and at a dose not greater than 500 (ig / day of fluticasone propionate administered by inhalation (or an equivalent dose of another inhaled corticosteroid).
• Demonstrate a VEFi of 40% to 80% (inclusive) of the expected normal values during the Screening visit and at the Baseline visit (Week 0) taking into account the corresponding suspension of the bronchodilator medication (an approximate value of the expected VEF 1%) It is acceptable).
• Reversibility documented within 12 months prior to the selection visit or during the selection visit. Reversibility is defined as an increase of> 15% (or> 14.5%) with respect to VEFi levels prior to dose administration, 15-30 minutes after inhalation of Salbutamol (albuterol) (pMDI or nebulizer, vial with a dose of 2.5 mg / unit).
• Meet the following criteria for 7 consecutive days, during the Selection Period: a) Administration of two or more inhalations per day of rescue medication Salbutamol (albuterol) in pMDI for at least 3 days, AND b) Submit one of the following symptoms of asthma: Suffer sleep disorders for at least one night, OR Suffer asthma symptoms for at least 3 days
• Women of childbearing age should obtain a negative result in the pregnancy test of human chorionic gonadotropin p (p-HCG) in urine performed at Baseline and Selection visits.
• You must also be a healthy person based on medical history, physical examination and clinical laboratory tests.
• Demonstrate a satisfactory technique in the use of pMDI.
• Demonstrate a predisposition and capacity to enter information in the Telephone Journal System.
• Demonstrate predisposition and capacity to substitute their prescription medication to treat asthma by the study medication during the duration of the study.
• Demonstrate predisposition and ability to attend scheduled visits and to complete the entire study.
• Grant written informed consent. The desire of the minors must be respected.
• Episode of asthma that has put at risk the life of the patient, within the last years or during the Period of selection. This category includes patients with a history of almost lethal asthma, hospitalization or previous intubation due to asthma in recent years. Patients should not be treated in an emergency room because of asthma in the last 3 months prior to the screening visit.
• History of the use of systemic corticosteroids (oral or injectable) within 3 months prior to the Screening visit.
• History of the use of monoclonal antibodies (eg, omalizumab) within the last 6 months.
• History of use of leukotriene receptor antagonists, for example, montelukast, from the previous week.
• Current evidence or history of any clinically significant disease or abnormality, including uncontrolled hypertension, uncontrolled coronary artery disease, congestive heart failure, myocardial infarction or cardiac arrhythmia, Clinically significant is defined as a disease that, according to the criteria of the Investigator, would put at risk the patient´s life through his participation in the study, or that would affect the result of the study.
• Infection of the upper or lower respiratory tract within 4 weeks prior to the Screening visit or during the Selection Period.
• Significant non-reversible lung disease (eg, chronic obstructive pulmonary disease [COPD], cystic fibrosis, bronchiectasis).
• Known state of human immunodeficiency virus (HIV) positive.
• History of cigarette consumption equivalent to 10 years-package (that is, at least 1 pack of 20 cigarettes per day for 10 years or 10 packages per day for 1 year, etc.).
• History of current cigarette consumption within 12 months prior to the Selection visit.
• Current evidence or history of alcohol or substance use within 12 months prior to the screening visit.
• Patients who have received beta-blocking agents, tricyclic antidepressants, monoamine oxidase inhibitors, anti-arrhythmics of the quinidine class or potent inhibitors of CYP 3A4 such as ketoconazole during the previous week.
• Current evidence or history of hypersensitivity or idiosyncratic reaction to the test medication or its components.
• Administration of an investigational drug within 30 days prior to the Screening visit (12 weeks if you received an oral or injectable steroid).
• Patients who are detained in an institution.
• Previous exhibition to FlutiForm
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:The baseline FEV1 to be used is the VEF measurement, pre-dose obtained at the baseline visit (Week 0). The FEV1 post-dose of Week 12 that will be used is the measurement of FEV1 at 2 hours post dose obtained in Week 12 (or the last FEV1 post-dose in the case of early withdrawals).<br>Measure:Change in FEV1 from the pre-dose on the morning of the baseline visit (Week 0) to 2 hours after the dose is administered in Week 12.<br>Timepoints:Week 12<br>
- Secondary Outcome Measures
Name Time Method