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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:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
185
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

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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