Study to Assess the Incidence of Local Oropharyngeal and Laryngeal Adverse Effects of Advair DISK… (NCT00235053) | Clinical Trial Compass
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 range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
. 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