AsthmaPhase 4NCT00235053
Study to Assess the Incidence of Local Oropharyngeal and Laryngeal Adverse Effects of Advair DISKUS 250/50 mcg BID
A Phase 4 study testing fluticasone/salmeterol DISKUS 250/50 in people with Asthma and Candidiasis, Oral, run by Allergy & Asthma Medical Group & Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Asthma, Candidiasis, Oral, Voice Disorders
- What is being tested?
- fluticasone/salmeterol DISKUS 250/50
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Nov 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.)
Who cannot join
- 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
Show all 20Show fewer
- 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
- History within the last 2 years of moderate asthma requiring prednisone on more than two occasions per year
- Treatment with any investigational drug within the past 30 days
- 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.
- 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).
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Allergy & Asthma Medical Group & Research Center
San Diego, California, 92123
About this study
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
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.
Read the 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.
- Conditions
- Asthma, Candidiasis, Oral, Voice Disorders
- Being tested
- fluticasone/salmeterol DISKUS 250/50
- Keywords
- asthma, candidiasis, oral, voice disorders
- Medical subject headings
- Asthma, Candidiasis, Oral, Voice Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluticasone/salmeterol DISKUS 250/50Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2005 (estimated)
- Study startAug 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants
Sponsor and investigators
- Lead sponsor
- Allergy & Asthma Medical Group & Research Center
- Sponsor type
- University, hospital or other
- Investigators
- Eli O Meltzer, MD, Principal investigator, Allergy & Asthma Medical Group & Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00235053
- Sponsor's protocol ID
- NONE0-L00081
- Status last verified
- Jan 2024
- First submitted
- 6 Oct 2005
- Last updated
- 30 Jan 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00235053
- Acronym / sponsor ID
- NONE0-L00081
- Conditions
- Asthma, Candidiasis, Oral, Voice Disorders
- Keywords
- asthma, candidiasis, oral, voice disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants
- Lead sponsor
- Allergy & Asthma Medical Group & Research CenterUniversity, hospital or other
- Study start
- Aug 2005
- Study completion
- Nov 2005
- First posted
- 10 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or Female, 18-55 years of age. Females will be eligible only if they are:
- History of mild persistent asthma for at least 6 months as defined by NIH NHLBI April 19971
- No inhaled corticosteroid therapy. (Previous use of leukotriene receptor antagonists, and/or cromones, in addition to bronchodilators also allowed.)
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluticasone/salmeterol DISKUS 250/50 | Drug | – |
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.
10 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eli O Meltzer, MD principal investigator
Allergy & Asthma Medical Group & Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing fluticasone/salmeterol DISKUS 250/50 in people with Asthma and Candidiasis, Oral, run by Allergy & Asthma Medical Group & Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.