Study to Assess the Incidence of Local Oropharyngeal and Laryngeal Adverse Effects of Advair DISKUS 250/50 mcg BID
Condition: Asthma; Candidiasis, Oral; Voice Disorders
MeSH terms: Candidiasis; Candidiasis, Oral; Asthma; Voice Disorders
Study type: Interventional
Phase: Phase 4

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 description: 
      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 technologies for objective voice assessment have
      also been developed and these permit greater ability to quantify voice changes. These
      advances permit better measures of the potential adverse effects of inhaled corticosteroids
      on voice both with regard to onset of abnormalities and with regard to magnitude of effects.

      This pilot study is an initial probe into clarifying the potential of the inhaled
      corticosteroid, fluticasone propionate delivered in the Advair DISKUS device to produce oral
      candidiasis and voice changes, and to determine the best measurement to quantitate
      objectively that effect.
    

Intervention name(s): fluticasone/salmeterol DISKUS 250/50
Intervention type(s): Drug
Intervention MeSH terms: Fluticasone; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: asthma; candidiasis, oral; voice disorders