Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00235053
Status:
COMPLETED
Last Update Posted:
2024-01-30
First Post:
2005-10-06
Brief Title:
Study to Assess the Incidence of Local Oropharyngeal and Laryngeal Adverse Effects of Advair DISKUS 25050 mcg BID
Sponsor:
Allergy Asthma Medical Group Research Center
Organization:
Allergy Asthma Medical Group Research Center
Study Overview
Official Title:
A Pilot Study to Assess the Incidence of Local Oropharyngeal and Laryngeal Adverse Effects of Advair DISKUS 25050 mcg BID as Assessed by the Development of Laryngitis and Oropharyngeal Candidiasis in Adults With Mild Persistent Asthma
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 individuals 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
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 individuals 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None