A 12-week study to evaluate the effectiveness and safety of Fp Spiromax® using a range of doses, given twice daily compared with a non-active drug in Adolescent and Adult subjects with persistent Asthma uncontrolled on non-steroidal therapy
- Conditions
- Persistent AsthmaTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2010-023600-27-ES
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
1. Written informed consent/assent signed and dated by the subject and/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, and 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 (NIH).
5. Severity of Disease: A best forced expiratory volume in one 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.
6. Reversibility of Disease: Demonstrated a >= 15% reversibility of FEV1 within 30 minutes 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 must be on a short-acting Beta2-agonist alone or a non-corticosteroid maintenance medication (with or without a short-acting Beta2-agonist) for >= 3 months preceding the Screening Visit. Subjects must not have used an inhaled corticosteroid for at least 6 weeks preceding the Screening Visit.
Exception: Based upon the investigator's judgment that there is no inherent harm in changing the subject's current ICS therapy and the subject provides consent, subjects onlow dose ICS (100mcg Fp BID or equivalent) may be switched to a short acting Beta2-agonist alone at a Pre-screening Visit. The subject will be required to return to the clinic to complete the Screening Visit once the 2-week washout period has been completed.
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 its 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 beta 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
a) 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 and not undergoing treatment to reverse infertility
or is of
b) Child-bearing potential, willing to commit to using a consistent and acceptable method of birth control as defined below for the duration of the study:
- Systemic contraception used for >=1 month prior to screening, including birth control pills, transdermal patch (Ortho Evra®),
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 & the Randomization Visit.
3. Any asthma exacerbation requiring oral corticosteroids within 3 months of the Screening Visit. A subject must not have had any hospitalization for asthma within 6 months 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 one 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, including immediate or delayed hypersensitivity to any Beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or 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 12 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to evaluate the dose response, efficacy and safety of 4 different doses of fluticasone propionate (12.5, 25, 50, and 100mcg) delivered as Fluticasone Spiromax® Inhalation Powder (Fp Spiromax) when administered twice daily in subjects 12 years of age and older with persistent asthma uncontrolled on non-steroidal therapy.;Secondary Objective: Not applicable;Primary end point(s): The primary efficacy endpoint is:<br>- 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: Primary efficacy endpoint timeline is over the 12-week treatment period.<br><br>The primary pharmacokinetic endpoint:<br>At Treatment Visit 1, a sub-set of subjects (Pharmacokinetic [PK] cohort) from pre-selected study centers will have serial blood samples obtained immediately prior to and at scheduled times for 12 hours after administration of study medication for PK assessments.
- Secondary Outcome Measures
Name Time Method