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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00235053
Recruitment Status : Unknown
Verified September 2005 by Allergy & Asthma Medical Group & Research Center.
Recruitment status was:  Active, not recruiting
First Posted : October 10, 2005
Last Update Posted : January 31, 2006
Information provided by:
Allergy & Asthma Medical Group & Research Center

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.

Condition or disease Intervention/treatment Phase
Asthma Candidiasis, Oral Voice Disorders Drug: fluticasone/salmeterol DISKUS 250/50 Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Oropharyngeal Candidiasis in Adults With Mild Persistent Asthma
Study Start Date : August 2005
Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  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.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or Female, 18-55 years of age. Females will be eligible only if they are:

    1. Surgically sterilized, post-menopausal, abstinent, or practicing adequate method of birth control, and if they have a
    2. Negative urine pregnancy test (females of childbearing potential)
  2. History of mild persistent asthma for at least 6 months as defined by NIH NHLBI April 19971

At Visit 1 (Screening) treatment for the last 30 days prior to screening must be:

  • No inhaled corticosteroid therapy. (Previous use of leukotriene receptor antagonists, and/or cromones, in addition to bronchodilators also allowed.)

Exclusion Criteria:

  1. Female subjects who are pregnant or trying to become pregnant
  2. Breast feeding
  3. Current patient reported hoarseness or sore throat
  4. Presence of oropharyngeal thrush (as determined by investigator examination without culture results)
  5. Unresolved fungal, viral or bacterial infection elsewhere in the body
  6. Viral or bacterial respiratory tract infection within the last 14 days
  7. History of persistent gastro-esophageal reflux refractory to conventional treatment within the last 30 days
  8. 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
  9. History of inflammatory arthritis requiring immunosuppressive or corticosteroid therapy
  10. History of glaucoma, cataracts (lens opacities), retinal disease, or blindness
  11. Any serious concomitant disease such as cancer or serious renal, hepatic, cardiac, immunodeficiency, neurological, psychiatric, or other disease
  12. Any medical condition that, in the judgment of the investigator, might interfere with the study, require treatment or make implementation of the protocol or interpretation of the study results difficult
  13. Active or quiescent tuberculosis infections of the respiratory tract
  14. History of chronic bronchitis, COPD or emphysema
  15. History of alcohol abuse (more than 2 drinks/day on average) or drug abuse within the past 2 years
  16. History within the last 2 years of moderate asthma requiring prednisone on more than two occasions per year
  17. Treatment with any investigational drug within the past 30 days
  18. More than 1 short (less than 2 weeks) course of systemic corticosteroids in the previous year prior to screening (Visit 1) or have had systemic corticosteroids in the past pervious 2 months prior to Visit 1.
  19. Subjects can be on maintenance immunotherapy but cannot have begun an immunotherapy regimen or have had a change in their immunotherapy regimen within 30 days prior to screening (Visit 1).
  20. Subjects may be on intranasal steroid if it has been maintained for 4 weeks prior to screen and a constant stable dose is maintained for the duration of the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00235053

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United States, California
Allergy & Asthma Medical Group & Research Center
San Diego, California, United States, 92123
Sponsors and Collaborators
Allergy & Asthma Medical Group & Research Center
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Principal Investigator: Eli O Meltzer, MD Allergy & Asthma Medical Group & Research Center

Layout table for additonal information Identifier: NCT00235053     History of Changes
Other Study ID Numbers: NONE0-L00081
First Posted: October 10, 2005    Key Record Dates
Last Update Posted: January 31, 2006
Last Verified: September 2005
Keywords provided by Allergy & Asthma Medical Group & Research Center:
candidiasis, oral
voice disorders
Additional relevant MeSH terms:
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Candidiasis, Oral
Voice Disorders
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Laryngeal Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mouth Diseases
Stomatognathic Diseases
Salmeterol Xinafoate
Fluticasone-Salmeterol Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents