Severe Persistent Asthma
Conditions
Interventions
Product Name: Fluticasona Spiromax o Fp Spiromax
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: Propionato de fluticasona
CAS Number: 80474-14-2
Other descriptive name: PROPIONATO DE FLUT
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent/assent signed & dated by the subject &/or parent/legal guardian before conducting any study related procedure. 2. Male or female 12 years and older, as of the Screening Visit. Male or female 18 years and older, as of the Screening Visit, in countries where local regulations or the regulatory status of study medication permit enrollment of adults only. 3. General good health, free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the subject at increased risk during the study. 4. Asthma Diagnosis: Asthma as defined by the National Institutes of Health. 5. Severity of Disease: - A best forced expiratory volume in 1 second (FEV1) of 40%-85% of the predicted normal value during the Screening Visit. NHANES III predicted values will be used for subjects aged >= 12 years and adjustments to predicted values will be made for African American subjects - Experienced at least 1 asthma exacerbation (requiring systemic corticosteroids, emergency room visit, or hospitalization) within 12 months of the Screening Visit 6. Reversibility of Disease: Demonstrated a >= 15% reversibility of FEV1 within 30 mins following 2 inhalations of albuterol/salbutamol inhalation aerosol (if required, spacers are permitted for reversibility testing only) at the Screening Visit. If a subject fails to demonstrate an increase in FEV1 >= 15% then the subject is not eligible for the study and will not be allowed to re-screen. 7. Current Asthma Therapy: Subjects will be required to be on a short-acting Beta2-agonist and inhaled corticosteroid for a minimum of 8 weeks before the Screening Visit and have been maintained on a stable dose of inhaled corticosteroids for 4 weeks prior to the Screening Visit at one of the following doses: Fluticasone propionate HFA MDI (>= 880 mcg), Fluticasone propionate DPI (>=1000 mcg) Beclomethasone dipropionate DPI (>= 2000 mcg), Beclomethasone dipropionate HFA (QVAR) (>= 640 mcg), Beclomethasone dipropionate HFA (Clenil Modulite) >= 2000 mcg), Budesonide DPI (>= 1600 mcg), Budesonide MDI (>= 1600 mcg), Flunisolide (>= 2000 mcg) Triamcinolone acetonide (>= 2000 mcg), Mometasone furoate DPI (>= 880 mcg), Ciclesonide HFA MDI (640 mcg) 8. Short-Acting Beta2-Agonists: All subjects must be able to replace their current short-acting Beta2-agonists with albuterol/salbutamol inhalation aerosol at the Screening Visit for use as needed for the duration of the study. The use of spacer devices with the metered dose inhaler (MDI) will not be allowed during the study with exception of it's use during reversibility testing at the Screening Visit. Nebulized albuterol/salbutamol will not be allowed at any time during the study. Subjects must be able to withhold all inhaled short-acting Beta2 sympathomimetic bronchodilators for at least 6 hours prior to all study visits. 9. If female, is currently not pregnant, breast feeding, or attempting to become pregnant, has a negative serum pregnancy test, and is of - Non-childbearing potential, defined as: - Before menarche, or - >= 1 year post-menopausal, or - Surgically sterile (tubal ligation, bilateral oophorectomy, or hysterectomy), or - Congenital sterility, or - Diagnosed as infertile & not undergoing treatment to reverse infertility or is of - Child-bearing potential, willing to commit to using a consistent and acceptable method of birth control as defined below for the dura
Exclusion criteria
Exclusion criteria: 1. History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation &/or was associated with hypercapnea, respiratory arrest or hypoxic seizures. 2. Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 2 weeks of the Screening Visit. In addition, the subject must be excluded if such infection occurs between the Screening Visit and the Randomization Visit. 3. Any asthma exacerbation requiring oral corticosteroids within 1 month of the Screening Visit. A subject must not have had any hospitalization for asthma within 2 month prior to the Screening Visit. 4. Presence of glaucoma, cataracts, ocular herpes simplex, or malignancy other than basal cell carcinoma. 5. Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular (e.g congestive heart failure, known aortic aneurysm, clinically significant cardiac arrhythmia or coronary heart disease), hepatic, renal, hematological, neuropsychological, endocrine (e.g uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison's disease, Cushing's syndrome), gastrointestinal (e.g poorly-controlled peptic ulcer, GERD), or pulmonary (e.g chronic bronchitis, emphysema, bronchiectasis with the need for treatment, cystic fibrosis, bronchopulmonary dysplasia, chronic obstructive pulmonary disease). 6. Have any of the following conditions that, in the judgment of the investigator, might cause participation in this study to be detrimental to the subject, including, but not limited to: - Current malignancy excluding basal cell carcinoma; History of malignancy is acceptable only if the subject has been in remission for 1 year prior to the Screening Visit. - Current or untreated tuberculosis; History of tuberculosis is acceptable only if a subject has received an approved prophylactic treatment regimen or an approved active treatment regimen and has had no evidence of active disease for a minimum of 2 years - Uncontrolled hypertension (systolic BP >= 160 or diastolic BP >100) - Stroke within 3 months prior to the Screening Visit - Immunologic compromise 7. History of a positive test for HIV, hepatitis B or hepatitis C infection. 8. Clinical visual evidence of oral candidiasis at the Screening Visit. 9. History of any adverse reaction to any intranasal, inhaled or systemic corticosteroid therapy. Known/suspected sensitivity to the constituents of the dry powder inhalers used in the study (i.e lactose). 10. History of severe allergy to milk protein. 11. Use of systemic, oral or depot corticosteroids within 4 weeks prior to the Screening Visit - Use of topical corticosteroids (<= 1% hydrocortisone cream) for dermatological disease is permitted - Use of intranasal corticosteroids at a stable dose for at least 4 weeks prior to the Screening Visit and throughout the study is permitted 12. Use of immunosuppressive medications within 4 weeks prior to the Screening Visit and during the study. 13. Immunotherapy at a stable dose for at least 90 days prior to the Screening Visit and throughout the study for the treatment of allergies is permitted. 14. Use of potent Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g ritonavir, ketoconazole, itraconazole) within 4 weeks prior to the Screening Visit. 15. History of alcohol or drug abuse within 2 years preceding the Screening Visit. 16. Current smoker or a smoking
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the dose response, efficacy and safety of 4 different doses of fluticasone propionate (50, 100, 200, and 400mcg) delivered as Fluticasone Spiromax® Inhalation Powder (Fp Spiromax) when administered twice daily in subjects 12 years of age and older with severe persistent asthma who are uncontrolled on high dose ICS therapy.;Secondary Objective: Not applicable.;Primary end point(s): The primary efficacy endpoint is: - Change from baseline in trough (AM pre-dose and pre-rescue bronchodilator) FEV1 over the 12-week Treatment Period;Timepoint(s) of evaluation of this end point: The primary efficacy endpoint is: - Change from baseline in trough (AM pre-dose and pre-rescue bronchodilator) FEV1 over the 12-week Treatment Period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy Endpoint: - Change from baseline in weekly average of daily trough (pre-dose and pre-rescue bronchodilator) AM PEF over the 12-week Treatment Period - Change from baseline in weekly average of daily PM PEF over the 12-week Treatment Period - Change from baseline in the percentage of symptom-free 24-hour periods during the 12-week Treatment Period - Change from baseline in the percentage of rescue-free 24-hour periods during the 12-week Treatment Period;Timepoint(s) of evaluation of this end point: - Change from baseline in weekly average of daily trough (pre-dose and pre-rescue bronchodilator) AM PEF over the 12-week Treatment Period - Change from baseline in weekly average of daily PM PEF over the 12-week Treatment Period - Change from baseline in the percentage of symptom-free 24-hour periods during the 12-week Treatment Period - Change from baseline in the percentage of rescue-free 24-hour periods during the 12-week Treatment Period | — |
Countries
Belgium, Bulgaria, Croatia, Germany, Greece, Hungary, Israel, Poland, Russian Federation, Serbia, Spain, Ukraine, United Kingdom, United States
Contacts
Public ContactTeva Global Respiratory R&D
Teva Branded Pharmaceutical Products R&D, Inc.
Outcome results
None listed