Allergic AsthmaPhase 4NCT00980707
Utility of Versican and Hyaluronan Measurement in Induced Sputum as Biomarkers of Asthma
A Phase 4 study testing Inhaled corticosteroid (fluticasone) in people with Allergic Asthma, run by Associated Scientists to Help Minimize Allergies at 1 site in United States.
Trial summary
The purpose of this study is to determine the role of versican and hyaluronan measurements in induced sputum as biomarkers of asthma. Enroll 10 subjects with mild persistent asthma who are not receiving treatment with a controller therapy. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Asthma
- What is being tested?
- Inhaled corticosteroid (fluticasone)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Nov 2010
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Allergic asthma defined as a positive methacholine challenge
Who cannot join
- Non-atopic patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Associated Scientists to Help Minimize Allergies
Seattle, Washington, 98105
About this study
Official title: Utility of Versican and Hyaluronan Measurement in Induced Sputum as Biomarker of Asthma
The purpose of this study is to determine the role of versican and hyaluronan measurements in induced sputum as biomarkers of asthma. Enroll 10 subjects with mild persistent asthma who are not receiving treatment with a controller therapy.
Read the detailed description
We will compare spirometry, eNO and sputum measurements of versican and hyaluronan before and after treatment with fluticasone 220 ug/bid.
- Conditions
- Allergic Asthma
- Being tested
- Inhaled corticosteroid (fluticasone)
- Keywords
- versican, hyaluronan, sputum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled corticosteroid (fluticasone)Drug
Also called fluticasone
inhaled fluticasone 220 ug/bid
| Study group | Role | What they receive |
|---|---|---|
| inhaled corticosteroid | Experimental | All asthmatics will start inhaled corticosteroids. Receives: Drug: Inhaled corticosteroid (fluticasone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare hyaluronan and versican in asthmatics versus atopic non-asthmatics.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionJun 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Associated Scientists to Help Minimize Allergies
- Sponsor type
- University, hospital or other
- Collaborators
- Benaroya Research Institute, GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Leonard C Altman, MD, Principal investigator, Associated Scientists to Help Minimize Allergies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00980707
- Sponsor's protocol ID
- AI-005 versican
- Status last verified
- Jan 2012
- First submitted
- 17 Sep 2009
- Last updated
- 19 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Versican and Hyaluronan Measurement in Induced Sputum as Biomarker of Asthma
- ClinicalTrials.gov ID
- NCT00980707
- Acronym / sponsor ID
- AI-005 versican
- Conditions
- Allergic Asthma
- Keywords
- versican, hyaluronan, sputum
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Associated Scientists to Help Minimize AllergiesUniversity, hospital or other
- Collaborators
- Benaroya Research Institute, GlaxoSmithKline
- Study start
- Aug 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 21 Sep 2009 (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.
The purpose of this study is to determine the role of versican and hyaluronan measurements in induced sputum as biomarkers of asthma. Enroll 10 subjects with mild persistent asthma who are not receiving treatment with a controller therapy.
Detailed description
We will compare spirometry, eNO and sputum measurements of versican and hyaluronan before and after treatment with fluticasone 220 ug/bid.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| inhaled corticosteroid | Experimental | Drug: Inhaled corticosteroid (fluticasone)All asthmatics will start inhaled corticosteroids. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Allergic asthma defined as a positive methacholine challenge
Key exclusion criteria (1 listed)
- Non-atopic patients
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 |
|---|---|---|
| Inhaled corticosteroid (fluticasone)Also: fluticasoneinhaled fluticasone 220 ug/bid | Drug | inhaled corticosteroid |
Primary outcome
Compare hyaluronan and versican in asthmatics versus atopic non-asthmatics.
Time frame: 1 year
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 19 Jan 2012.
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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.
Leonard C Altman, MD principal investigator
Associated Scientists to Help Minimize Allergies
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 Inhaled corticosteroid (fluticasone) in people with Allergic Asthma, run by Associated Scientists to Help Minimize Allergies 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 1 inclusion and 1 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 19 Jan 2012. 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?
Compare hyaluronan and versican in asthmatics versus atopic non-asthmatics. (time frame: 1 year). 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 19 Jan 2012.