Mild to Moderate-Severe Asthma
Conditions
Interventions
Product Name: Flutiform HFA MDI 100/10mcg
Pharmaceutical Form: Pressurised inhalation, suspension
INN or Proposed INN: Fluticasone Propionate
Concentrat
Sponsors
Skyepharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Female or male patients who are steroid-requiring will be eligible for the study if they meet all of the following criteria: 1. Age greater than or equal to 12 years at the Screening Visit. 2. History of asthma for greater than or equal to 12 months prior to the Screening Visit. For the purposes of this study, ‘asthma’ is defined by National Asthma Education and Prevention Program (NAEPP). 3. Documented use of an inhaled corticosteroid as asthma maintenance therapy for at least 4 weeks prior to the Screening Visit and at a dose not greater than 500mcg/day Fluticasone propionate inhalation HFA pMDI or equivalent dose for other inhaled corticosteroids. 4. Demonstrate a FEV1 of 40% to 85% (inclusive) of predicted normal values during the Screening Visit and at the Baseline Visit (Week 0) following appropriate withholding of asthma medications. 5. Documented reversibility of at least 15% in FEV1 within 6 months of the Screening Visit. 6. Meet the following criteria during the Run-In Period of 14 plus or minus 3 days while on treatment with twice daily Fluticasone HFA pMDI: a) Use of two or more inhalations per day of rescue Salbutamol pMDI for at least 3 days, AND b) One of the following asthma symptoms: - At least one night with sleep disturbance, OR - At least 3 days with asthma symptoms. 7. Females of child-bearing potential must have a negative urine b human chorionic gonadotropin (bhCG) pregnancy test at the Baseline Visit (Week 0). Females are eligible only if they are not pregnant or lactating, and are either: a) 2 years postmenopausal, or b) surgically sterile (tubal ligation or hysterectomy), or c) using acceptable methods of contraception. For purposes of this study, acceptable methods of birth control include: - Birth control pills (³ 1 month prior to the Screening Visit, and patient agrees to continue taking them for 1 month after the completion of the study); - Regulatory approved implantable contraceptive (e.g., Mirena®, Norplant®) (greater than or equal to 1 month prior to the Screening Visit, and patient agrees to continue to use it for 1 month after the completion of the study); - Regulatory approved injectable contraceptive (e.g., Depo-Provera®) (greater than or equal to 1 month prior to the Screening Visit, and patient agrees to continue to use it for 1 month after the completion of the study); - Double barrier methods (e.g., condoms with spermicide); - Intrauterine contraceptive devices (IUDs or coil); - Lifestyle with a personal choice of abstinence; - Non-heterosexual lifestyle; - Vasectomy of sexual partner. 8. Must otherwise be healthy as judged by medical history, physical examination, and clinical laboratory tests. 9. Demonstrate satisfactory technique in the use of pMDI. 10. Willing and able to accurately enter information into the telephone diary system and complete patient diary cards. 11. Willing and able to substitute study medication for their prescribed asthma medication for the duration of the study. 12. Provide written informed consent. The wishes of minors must be
Exclusion criteria
Exclusion criteria: Patients will not be eligible for the study if they meet any of the following criteria: 1. Life-threatening asthma within the past year or during the Run-In Period. This category includes those patients with a history of near-fatal asthma, a hospitalization or an emergency visit for asthma or prior intubation for asthma. 2. History of systemic (oral or injectable) corticosteroid medication within 3 months before the Screening Visit or during the Run-In Period. 3. History of omalizumab use within the past 6 months. 4. History of leukotriene receptor antagonist use, e.g. montelukast, within the past week. 5. Current evidence or history of any clinically significant disease or abnormality including uncontrolled coronary artery disease, congestive heart failure, myocardial infarction, or cardiac dysrhythmia. ‘Clinically significant’ is defined as any disease that, in the opinion of the Investigator, would put the patient at risk through study participation, or which would affect the outcome of the study. 6. An upper or lower respiratory infection within 4 weeks prior to the Screening Visit or during the Run-In Period. 7. Significant, non-reversible, pulmonary disease (e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis, bronchiectasis). 8. Known Human Immunodeficiency Virus (HIV)-positive status. 9. A smoking history equivalent to “10 pack years” (i.e., at least 1 pack of 20 cigarettes/day for 10 years or 10 packs/day for 1 year, etc.). 10. Current smoking history within 12 months prior to the Screening Visit. 11. Current evidence or history of alcohol and/or substance abuse within 12 months prior to the Screening Visit. 12. Patients who had taken b-blocking agents, tricyclic antidepressants, monoamine oxidase inhibitors, astemizole (Hismanal), quinidine type antiarrhythmics or potent CYP 3A4 inhibitors such as ketoconazole within the past week. 13. Current evidence or history of hypersensitivity or idiosyncratic reaction to test medications or components. 14. Receipt of an investigational drug within 30 days of the Screening Visit (12 weeks if an oral or injectable steroid). 15. Patients who are confined in an institution.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess long-term safety of SKP Flutiform HFA pMDI (100/10mcg and 250/10mcg) after twice daily treatment in adult and adolescent patients with mild to moderate-severe asthma over a period of up to 12 months.;Secondary Objective: To assess the efficacy of SKP Flutiform HFA pMDI (100/10mcg and 250/10mcg) after twice daily treatment in adult and adolescent patients with mild to moderate-severe asthma over a period of up to 12 months.; Primary end point(s): The primary safety parameter is the incidence of AEs emerging during treatment with FlutiForm. The secondary safety endpoints include: 1. Changes in the measurements of vital signs 2. Changes in clinical laboratory test values 3. Electrocardiograms The efficacy endpoints will include: 1. FEV1, PEFR, and FVC (using spirometry data) | — |
Countries
Germany, Hungary, United Kingdom
Outcome results
None listed