A Pilot Study to Assess the Incidence of Local Oropharyngeal and Laryngeal Adverse Effects of Advair DISKUS 250/50 mcg BID as Assessed by the Development of Laryngitis and Oropharyngeal Candidiasis in Adults With Mild Persistent Asthma

NONE0-L00081

This Pilot study is designed to explore the rate of local side effects of fluticasone as delivered by Advair and to determine the best outcome measure to assess these effects. This study is the initial step, and will be followed by a larger scale study.

2005-08-01

2005-11-01

Completed

Early phase I

13

Inclusion Criteria: 1. Male or Female, 18-55 years of age. Females will be eligible only if they are: 1. Surgically sterilized, post-menopausal, abstinent, or practicing adequate method of birth control, and if they have a 2. Negative urine pregnancy test (females of childbearing potential) 2. History of mild persistent asthma for at least 6 months as defined by NIH NHLBI April 19971 At Visit 1 (Screening) treatment for the last 30 days prior to screening must be: * No inhaled corticosteroid therapy. (Previous use of leukotriene receptor antagonists, and/or cromones, in addition to bronchodilators also allowed.) Exclusion Criteria: 1. Female subjects who are pregnant or trying to become pregnant 2. Breast feeding 3. Current patient reported hoarseness or sore throat 4. Presence of oropharyngeal thrush (as determined by investigator examination without culture results) 5. Unresolved fungal, viral or bacterial infection elsewhere in the body 6. Viral or bacterial respiratory tract infection within the last 14 days 7. History of persistent gastro-esophageal reflux refractory to conventional treatment within the last 30 days 8. Has smoked within the previous 6 months or has greater than a lifetime 10 pack-year smoking history or regular exposure to environmental tobacco smoke 9. History of inflammatory arthritis requiring immunosuppressive or corticosteroid therapy 10. History of glaucoma, cataracts (lens opacities), retinal disease, or blindness 11. Any serious concomitant disease such as cancer or serious renal, hepatic, cardiac, immunodeficiency, neurological, psychiatric, or other disease 12. Any medical condition that, in the judgment of the investigator, might interfere with the study, require treatment or make implementation of the protocol or interpretation of the study results difficult 13. Active or quiescent tuberculosis infections of the respiratory tract 14. History of chronic bronchitis, COPD or emphysema 15. History of alcohol abuse (more than 2 drinks/day on average) or drug abuse within the past 2 years 16. History within the last 2 years of moderate asthma requiring prednisone on more than two occasions per year 17. Treatment with any investigational drug within the past 30 days 18. More than 1 short (less than 2 weeks) course of systemic corticosteroids in the previous year prior to screening (Visit 1) or have had systemic corticosteroids in the past pervious 2 months prior to Visit 1. 19. Subjects can be on maintenance immunotherapy but cannot have begun an immunotherapy regimen or have had a change in their immunotherapy regimen within 30 days prior to screening (Visit 1). 20. Subjects may be on intranasal steroid if it has been maintained for 4 weeks prior to screen and a constant stable dose is maintained for the duration of the trial.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 13}}

2024-01-30