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Clinical Trials/EUCTR2009-017669-44-PL
EUCTR2009-017669-44-PLActive, not recruitingNot Applicable

A study of the Effects of Inhaled Fliticasone Furotate/GW642444 versus Placebo on HPA Axis of Adolescent and Adult Asthmatics.

GlaxoSmithKline0 sites185 target enrollmentStarted: February 22, 2010Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
185

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • 1. Type of Subject: Outpatient and able to complete two overnight domiciled clinic
  • 2. Age =18 to =65.
  • 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
  • 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
  • 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 and is recorded as being of African American/African heritage race, then the
  • African-American equations will be used. Otherwise the Caucasian equations will be
  • 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 <8 mg/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 and willing to give written informed
  • consent to take part in the study.
  • 9. Compliance: Subjects must be judged by the investigator as able to comply with
  • study procedures and completion of the d

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 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 protiocol for further information
  • 4. Asthma Exacerbation: Any asthma exacerbation requiring systemic corticosteroids
  • within 12weeks 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
  • 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 prohibitedd 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 for the duration of 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 aspect
  • of this study protocol, scheduled visits to the study center, non-compliance with
  • investigational product, or procedu

Investigators

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