Asthma MedDRA version: 12.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Product Name: Fluticasone furoate
Product Code: Fluticasone furoate
Pharmaceutical Form: Inhalation powder, pre-dispensed
INN or Proposed INN: GW685698 (Fluticasone furoate)
CAS Number: 397864-44-7
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Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent: Subjects must give their signed and dated written informed consent to participate 2. Type of Subject: Outpatients 12 years of age or older at Visit 1 (or =18 years of age if local regulations or the regulatory status of study medication permit enrolment of adults only) with a diagnosis of asthma as defined by the National Institutes of Health [NIH, 2007] at least 12 weeks prior to Visit 1. 3. Gender: Male or Eligible Female, defined as non-childbearing potential or childbearing potential using an acceptable method of birth control consistently and correctly, as defined by the following: • Male partner who is sterile prior to the female subject’s entry into the study and is the sole sexual partner for that female subject • Implants of levonorgestrel, etonogestrel • Injectable progestogen • Oral contraceptive (either combined estrogen/progestin or progestin only) • Any intrauterine device (IUD) with a documented failure rate of less than 1% per year • Double barrier method – spermicide plus a mechanical barrier (e.g., spermicide plus a male condom or a spermicide and female diaphragm). • Estrogenic vaginal ring • Percutaneous contraceptive patches • Females of childbearing potential who are not sexually active must commit to complete abstinence from intercourse throughout the clinical trial and for a period after the trial to account for elimination of the drug (minimum of six days) • Female subjects should not be enrolled if they are pregnant, lactating or plan to become pregnant during the time of study participation. A serum pregnancy test is required for females of childbearing potential at the initial screening visit (Visit 1) and Visit 9 or Early Withdrawal. In addition a urine pregnancy test will be performed on all females of childbearing potential at Visits 2 and 6 and a take-home test will be performed at Visit 10 (Follow up Visit/Contact). 4. Severity of Disease: A best pre-bronchodilator FEV1 of 60%-90% of the predicted normal value at the Visit 1 screening visit. Predicted values will be based upon NHANES III [Hankinson, 2010]. If a subject is recorded as having Hispanic or Latino ethnicity, then the Mexican-American equations will be used (irrespective of race). If a subject is recorded as being of African-American/African heritage race, then the African-American equations will be used. If a subject is recorded as being of Asian race, then the Asian adjustment will be used. Otherwise, the Caucasian equations will be used. 5. Reversibility of Disease: Demonstrated =12% and =200mL evening reversibility of FEV1 within 10-40 minutes following 2-4 inhalations of albuterol/salbutamol inhalation aerosol (or equivalent nebulized treatment with albuterol/salbutamol solution) at screening (Visit 1). 6. Current Anti-Asthma Therapy: All subjects must be using an ICS for at least 12 weeks prior to Visit 1. Subjects must be taking a stable doses of ICS for at least 4 weeks prior to Visit 1. See Table 1 Page 18 of the protocol for examples of doses of commonly prescribed ICS medication. Dosing regimen (once or twice daily to equal the total daily dose shown below) should be restricted to the current local product datasheet: 7. Short-Acting Beta2-Agonists (SABAs): All subjects must be able to replace their current SABA treatment with albuterol/salbutamol aerosol inhaler at Visit1 for use as needed for the duration of the study. Subjects must be able to withhold albuterol/salbutamol for at least 6 hours prior to study v
Exclusion criteria
Exclusion criteria: 1. History of Life-threatening asthma: Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures within the last 10 years. 2. Respiratory Infection: Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of Visit 1 and led to a change in asthma management or, in the opinion of the Investigator, is expected to affect the subject’s asthma status or the subject’s ability to participate in the study. 3. Asthma Exacerbation: Any asthma exacerbation requiring oral corticosteroids or that resulted in overnight hospitalization requiring additional treatment for asthma within 6 months prior to Visit 1. 4. Concurrent Respiratory Disease: A subject must not have current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities other than asthma. 5. Other Concurrent Diseases/Abnormalities: A subject must not have any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the patient at risk through study participation or would confound the interpretation of the efficacy results if the condition/disease exacerbated during the study. View protocol for further information. 6. Oropharyngeal Examination: A subject will not be eligible for the run-in if he/she has clinical visual evidence of candidiasis at Visit 1. 7. Investigational Medications: A subject must not have used any investigational drug within 30 days prior to Visit 1 or within five half-lives (t½) of the prior investigational study (whichever is the longer of the two). 8. Allergies: • Drug Allergy: 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 new powder inhaler (i.e., lactose). • Milk Protein Allergy: History of severe milk protein allergy. 9. Concomitant Medication: • Administration of prescription or over the counter medication that would significantly affect the course of asthma, or interact with study drug. • Immunosuppressive Medications: A subject must not be using or require use of immunosuppressive medications during the study. • Note: Immunotherapy for the treatment of allergies is allowed during the study provided it was initiated 4 weeks prior to Visit 1 and subjects remain in the maintenance phase for the duration of the study. • Cytochrome P450 3A4 (CYP3A4) inhibitors: Subjects who have received a potent CYP3A4 inhibitor within 4 weeks of Visit 1(e.g., ritonavir, ketoconazole, itraconzole). 10. Compliance: A subject will not be eligible if he/she or his/her parent or legal guardian has any infirmity, disability, disease, or geographical location which seems likely (in the opinion of the Investigator) to impair compliance with any aspect of this study protocol, including visit schedule and completion of the daily diaries. 11. Tobacco Use: Current smoker or a smoking history of 10 pack years (e.g., 20 cigarettes/day for 10 years). A subject may not have used inhaled tobacco products within the past 3 months (i.e., cigarettes, cigars or pipe tobacco). 12. Affiliation with Inves
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and safety of fluticasone furoate 100mcg administered once daily in the evening in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 24 week treatment period.;Secondary Objective: N/A;Primary end point(s): Efficacy Endpoints: Change from baseline in clinic visit trough (pre-bronchodilator and pre-dose) FEV1 at the end of the 24 week treatment period. | — |
Countries
Belgium, Germany
Outcome results
None listed