Clinical Trial: Study to Assess the Incidence of Local Oropharyngeal and Laryngeal Adverse Effects of Advair DISKUS 250/50 Mcg BID

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: 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

Brief 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.

Detailed Summary:

Asthma is a chronic inflammatory disorder of the airways. The inflammation is associated with bronchial hyperresponsiveness, airflow obstruction, and respiratory symptoms including wheezing, coughing and chest tightness.

Inhaled corticosteroids are the most effective controller asthma medications. They are indicated for management of persistent asthma at all levels of severity. They have been documented to improve symptoms and pulmonary function and reduce exacerbations, need for quick-relief medications and airway hyperresponsiveness.

Despite their benefits, inhaled corticosteroids have been associated with adverse local effects. These include oral candidiasis and dysphonia. However, though these risks have been reported, they have not been carefully studied. The incidence of oral candidiasis in newly treated subjects and its onset within a carefully monitored timeframe have not been adequately assessed.

A more overtly undesirable effect is dysphonia. Data on it are usually collected from spontaneous reports by patients in clinical trials. However, awareness of dysphonia requires a certain degree of subjective discomfort to initiate the report. Subjective awareness of dysphonia often varies based on an individuals voice requirements. A singer, for example, is usually acutely aware of minor voice changes in contrast to someone who does not depend on voice quality. Nonetheless, voice abnormalities can probably occur with similar frequency in patients who are concerned or not concerned with their voice due to inhaled corticosteroids. New subjective scales for reporting on an individual’s voice have recently been validated and published in other areas. These scales have not been validated in patients with asthma or in subjects using inhaled corticosteroids. New technolog
Sponsor: Allergy & Asthma Medical Group & Research Center

Current Primary Outcome: 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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 1. Voice Related Quality of Life (VRQOL)
  • 2. Inhaled Corticosteroid Questionnaire (ICQ)
  • 3. Reflux Symptom Index (RSI)
  • 4. Videostroboscopy and Determination of Reflux Finding Score (RFS)
  • 5. Voice jitter
  • 6. Voice shimmer
  • 7. Signal to noise ratio
  • 8. Oropharyngeal Candida species culture
  • 9. Oropharyngeal Candida species related symptoms
  • 10. Oropharyngeal thrush on physical exam


Original Secondary Outcome: Same as current

Information By: Allergy & Asthma Medical Group & Research Center

Dates:
Date Received: October 6, 2005
Date Started: August 2005
Date Completion: November 2005
Last Updated: January 30, 2006
Last Verified: September 2005