EUCTR2009-017669-44-DE进行中（未招募）不适用
Study HZA106851: A Study of the Effects of Inhaled Fluticasone Furoate/GW642444 versus Placebo on the HPA Axis of Adolescent and Adult Asthmatics
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 185
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Type of Subject: Outpatient and able to complete two overnight domiciled clinic stays.
- •2.Age: =12 to =65 years of age (or =18 to =65 years of age if local regulations or the regulatory status of study medication permit enrolment of adults only). In Germany: =18 to =65 years.
- •3. Gender: Male or Eligible Female
- •To be eligible for entry into the study, females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control, 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 or etonogestrel
- •Injectable progestogen
- •Oral contraceptive (either combined estrogen/progestin or progestin only)
- •Estrogenic vaginal ring
- •Percutaneous contraceptive patches
- •Any intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year.
- •Double barrier method – condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository)
- •Abstinence: 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 will be required on all females of childbearing potential at Visit 1.
- •4. Asthma Diagnosis: A history of asthma as defined by the National Institutes of Health [NIH, 2007] for at least 12 weeks prior to Visit 1.
- •5. Severity of Disease: A best FEV1 of =50% of the predicted normal value during the Visit 1 screening visit. Predicted values will be based upon NHANES III. [Hankinson, 1999]. Note: 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. Otherwise, the Caucasian equations will be used.
- •6. Reversibility of Disease: Demonstrated a = 12% and =200mL reversibility of FEV1 within approximately 10 to 40 minutes following 2 to 4 inhalations of albuterol/salbutamol inhalation aerosol (if required, spacers are permitted for reversibility testing only) or one nebulized albuterol/salbutamol solution during the screening period or historical documentation of same FEV1 reversibility within 12 months prior to screening or a positive methacholine challenge test within 12 months prior to screening. A positive response to a methacholine challenge is defined as a 20% decrease in response to methacholine (PC20) of <8mg/ml.
- •7. Short-acting Beta2-Agonists: All subjects must be able to replace their current short-acting beta2-agonists with albuterol/salbutamol inhalation aerosol at Visit 1 for use as needed for the duration of the study. The use of spacer devices with metered dose inhaler (MDI) or nebulized albuterol/salbutamol will not be allowed during the study with the exception of their use during reversibility testing at Visit 1. Subjects must be able to withhold all inhaled short-acting beta sympathomimetic bronchodilators for at least 6 hours prior to study visits.
- •8. Informed Consent: All subjects must be able an
排除标准
- •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 5 years prior to Visit 1.
- •2. 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.
- •3. Respiratory Infection: Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear – view protocol for further information.
- •4. Asthma Exacerbation: Any asthma exacerbation requiring systemic corticosteroids within 12 weeks of Visit 1. A subject must not have had any overnight hospitalization for asthma within 6 months prior to Visit 1.
- •5. Concurrent Diseases/Abnormalities: Other Concurrent Diseases/Abnormalities: A subject must not have any clinically significant, uncontrolled condition or disease - 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 oral candidiasis at Visit 1.
- •7. Investigational Medications: Use of any investigational drug within 30 days prior to Visit 1
- •8. Previous Study Participation: A subject may not have previously been randomized to treatment in a Phase III fluticasone furoate/GW642444 combination product study (i.e., HZA106825, HZA106827, HZA106829, HZA106837, HZA106839, HZA113091).
- •9. Drug Allergy: Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy view protocol for further information.
- •10. Milk Protein Allergy: History of severe milk protein allergy
- •11. Immunosuppressive Medications: A subject must not be using or require use of immunosuppressive medications during the study.
- •12. Concomitant Medications: Use of prescription or over-the-counter medications that would significantly affect the course of asthma, view protocol for further information.
- •13. Systemic/Oral/Depot Corticosteroid: Administration of systemic, oral, or depot corticosteroids within 12 weeks prior to Visit 1 and during the study is prohibited.
- •14. Inhaled Corticosteroid Use: Use of an inhaled corticosteroid during the 4 weeks prior to Visit 1 and during the study is prohibited.
- •15. Intranasal Corticosteroids: Use is prohibited starting one day prior to Visit 1 and during the study.
- •16. Potent Cytochrome P450 3A4 (CYP3A4) inhibitors: A subject is not eligible if he/she is receiving potent CYP34A inhibitor within 4 weeks of Visit 1 and during the study (e.g., ritonavir, ketoconazole, itraconzole).
- •17. Long-acting beta2-agonists: Use is prohibited for 4 weeks prior to Visit 1 and during the study.
- •18. Extended-release short-acting beta2-agonists: Use is prohibited for the period of the prescribed dosing interval prior to the screening visit and for the duration of the study.
- •18.Intranasal Corticosteroids: Use is prohibited starting one day prior to Visit 1 and during the study.
- •19. Attendance: A subject will not be eligible if he/she or his/her parent or legal guardian has any infirmity, disability, or resides in a geographical location which seems likely (in the opinion of the Investigator) to impair compliance with any aspe
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