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

NCT00235053 | Completed Phase 4

• 1 other identifier: NONE0-L00081
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Candidiasis, Oral; Voice Disorders

Keywords

asthma; candidiasis, oral; voice disorders

Outcome Measures

Primary Outcomes (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 Outcomes (10)

• 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

Interventions

fluticasone/salmeterol DISKUS 250/50 DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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.)

You may not qualify if:

• Female subjects who are pregnant or trying to become pregnant
• Breast feeding
• 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
• History of inflammatory arthritis requiring immunosuppressive or corticosteroid therapy
• History of glaucoma, cataracts (lens opacities), retinal disease, or blindness
• Any serious concomitant disease such as cancer or serious renal, hepatic, cardiac, immunodeficiency, neurological, psychiatric, or other disease
• 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
• Active or quiescent tuberculosis infections of the respiratory tract
• History of chronic bronchitis, COPD or emphysema
• History of alcohol abuse (more than 2 drinks/day on average) or drug abuse within the past 2 years

Sponsors & Collaborators

• Allergy & Asthma Medical Group & Research Center: lead

Study Sites (1)

Allergy & Asthma Medical Group & Research Center

San Diego, California, 92123, United States

Location

MeSH Terms

Conditions

Asthma; Candidiasis, Oral; Voice Disorders

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Mouth Diseases; Stomatognathic Diseases; Laryngeal Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Eli O Meltzer, MD

  Allergy & Asthma Medical Group & Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 6, 2005
• First Posted: October 10, 2005
• Study Start: August 1, 2005
• Study Completion: November 1, 2005
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

US (1)