Study HZA106851: A Study of the Effects of Inhaled Fluticasone Furoate/GW642444 versus Placebo on the HPA Axis of Adolescent and Adult Asthmatics

GlaxoSmithKline Research & Development Ltd0 sites185 target enrollmentJanuary 22, 2010

ConditionsAsthma MedDRA version: 12.1Level: LLTClassification code 10003553Term: Asthma

DrugsMillipred Tablets (prednisolone tablets USP, 5 mg)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Asthma
Sponsor: GlaxoSmithKline Research & Development Ltd
Enrollment: 185
Status: Active, not recruiting
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 22, 2010

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GlaxoSmithKline Research & Development Ltd

Eligibility Criteria

Inclusion Criteria

•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

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 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