Allergic AsthmaNCT00214019
The Effect of Salmeterol on Eosinophil (EOS) Function
A study testing salmeterol and Fluticasone in people with Allergic Asthma, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This study is designed to test the hypothesis that salmeterol use, and not fluticasone use or the combination treatment with fluticasone and salmeterol, is associated with a greater number of sputum eosinophils following antigen challenge and, under these circumstances, the migrating peripheral blood eosinophils are… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Allergic Asthma
- What is being tested?
- salmeterol and Fluticasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2003to Jan 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 18-55 years of age
- history of asthma symptoms for the previous 6 months
- Forced Expiratory Value (FEV1) >75% of predicted
- positive prick skin test to cat, house dust mite or ragweed
Who cannot join
- history of life threatening asthma or anaphylaxis
- current smoker
- pregnant or breast-feeding
- evidence of an upper respiratory infection within 4 weeks of screening
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed to test the hypothesis that salmeterol use, and not fluticasone use or the combination treatment with fluticasone and salmeterol, is associated with a greater number of sputum eosinophils following antigen challenge and, under these circumstances, the migrating peripheral blood eosinophils are less adherent.
Read the detailed description
An antigen challenge is when a participant inhales either cat, ragweed, or dust dander in increasing concentrations until their lung function drops 15 or 20 percent.
- Conditions
- Allergic Asthma
- Being tested
- salmeterol, Fluticasone, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salmeterolDrug
Also called Seravent, Advair
salmeterol diskus 50 mcg twice per day
FluticasoneDrug
Also called flovent, advair
placebo diskus, fluticasone MDI 88 mcg twice per day
PlaceboDrug
Also called no drug, comparator treatment
placebo diskus
| Study group | Role | What they receive |
|---|---|---|
| Placebo Diskus | Placebo comparator | Placebo comparator Receives: Drug: Placebo |
| Salmeterol Diskus 50 mcg twice per day | Experimental | Salmeterol Diskus 50 mcg twice per day Receives: Drug: salmeterol |
| Placebo diskus, fluticasone | Experimental | placebo diskus, fluticasone MDI 88 mcg twice per day Receives: Drug: Fluticasone |
| Salmeterol, Fluticasone | Experimental | Salmeterol diskus 50 mcg BID, fluticasone MDI 88 mcg twice per day Receives: Drug: salmeterol; Drug: Fluticasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sputum Eosinophils (EOS) 24 Hours Post Antigen Challenge
Sputum samples were collected from the participants. Cell counts were made from these samples after treatment with 0.1% dithiothreitol. Percentage of eosinophils were reported. Time frame measurement was 24 hours after the subject had an antigen challenge.
Measured: Eosinophils are measured 24 hours after the subject has an antigen challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startNov 2003
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Allergic 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- William Busse, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00214019
- Sponsor's protocol ID
- H-2003-0469
- Status last verified
- Oct 2017
- First submitted
- 13 Sep 2005
- Last updated
- 21 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Salmeterol on Eosinophil (EOS) Function
- ClinicalTrials.gov ID
- NCT00214019
- Acronym / sponsor ID
- H-2003-0469
- Conditions
- Allergic Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Nov 2003 (actual)
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Posted 8 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to test the hypothesis that salmeterol use, and not fluticasone use or the combination treatment with fluticasone and salmeterol, is associated with a greater number of sputum eosinophils following antigen challenge and, under these circumstances, the migrating peripheral blood eosinophils are less adherent.
Detailed description
An antigen challenge is when a participant inhales either cat, ragweed, or dust dander in increasing concentrations until their lung function drops 15 or 20 percent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo Diskus | Placebo comparator | Drug: PlaceboPlacebo comparator |
| Salmeterol Diskus 50 mcg twice per day | Experimental | Drug: salmeterolSalmeterol Diskus 50 mcg twice per day |
| Placebo diskus, fluticasone | Experimental | Drug: Fluticasoneplacebo diskus, fluticasone MDI 88 mcg twice per day |
| Salmeterol, Fluticasone | Experimental | Drug: salmeterol, Drug: FluticasoneSalmeterol diskus 50 mcg BID, fluticasone MDI 88 mcg twice per day |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-55 years of age
- history of asthma symptoms for the previous 6 months
- Forced Expiratory Value (FEV1) >75% of predicted
- positive prick skin test to cat, house dust mite or ragweed
Key exclusion criteria (4 listed)
- history of life threatening asthma or anaphylaxis
- current smoker
- pregnant or breast-feeding
- evidence of an upper respiratory infection within 4 weeks of screening
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 |
|---|---|---|
| salmeterolAlso: Seravent, Advairsalmeterol diskus 50 mcg twice per day | Drug | Salmeterol Diskus 50 mcg twice per day, Salmeterol, Fluticasone |
| FluticasoneAlso: flovent, advairplacebo diskus, fluticasone MDI 88 mcg twice per day | Drug | Placebo diskus, fluticasone, Salmeterol, Fluticasone |
| PlaceboAlso: no drug, comparator treatmentplacebo diskus | Drug | Placebo Diskus |
Primary outcome
Sputum Eosinophils (EOS) 24 Hours Post Antigen Challenge
Time frame: Eosinophils are measured 24 hours after the subject has an antigen challenge
Sputum samples were collected from the participants. Cell counts were made from these samples after treatment with 0.1% dithiothreitol. Percentage of eosinophils were reported. Time frame measurement was 24 hours after the subject had an antigen challenge.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
William Busse, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing salmeterol and Fluticasone in people with Allergic Asthma, run by University of Wisconsin, Madison 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 4 inclusion and 4 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 21 Nov 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sputum Eosinophils (EOS) 24 Hours Post Antigen Challenge (time frame: Eosinophils are measured 24 hours after the subject has an antigen challenge). 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 21 Nov 2017; AzTrials last refreshed its copy on 29 Oct 2026.