CompletedPhase 4

Study to Assess the Incidence of Local Oropharyngeal and Laryngeal Adverse Effects of Advair DISKUS 250/50 mcg BID

United States13 participantsStarted 2005-08

Plain-language summary

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.

Who can participate

Age range18 Years – 55 Years

SexALL

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Inclusion criteria

✓. Male or Female, 18-55 years of age. Females will be eligible only if they are:
✓. Surgically sterilized, post-menopausal, abstinent, or practicing adequate method of birth control, and if they have a
✓. Negative urine pregnancy test (females of childbearing potential)
✓. History of mild persistent asthma for at least 6 months as defined by NIH NHLBI April 19971

Exclusion criteria

✕. Female subjects who are pregnant or trying to become pregnant
✕. Breast feeding
✕. Current patient reported hoarseness or sore throat
✕. Presence of oropharyngeal thrush (as determined by investigator examination without culture results)
✕. Unresolved fungal, viral or bacterial infection elsewhere in the body
✕. Viral or bacterial respiratory tract infection within the last 14 days
✕. History of persistent gastro-esophageal reflux refractory to conventional treatment within the last 30 days
✕. 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

What they're measuring

To determine the magnitude of change from baseline to end of study in the Voice Handicap Index (VHI) with Advair® DISKUS 250/50 mcg BID in subjects with mild persistent asthma.

Trial details

NCT IDNCT00235053

SponsorAllergy & Asthma Medical Group & Research Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

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