Allergic AsthmaNCT00710450
Effect of Montelukast on Basophils, In-vitro
An observational study of Allergic Asthma and Allergic Rhinitis, run by Creighton University at 1 site in United States.
Trial summary
Subjects with either allergic asthma or allergic rhinitis will be recruited to obtain blood. This blood will be used to be stimulated with to whatever the patient allergic. In the laboratory, this stimulated blood will be measured for histamine, leukotrienes, IL-13 and IL-3. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Allergic Asthma, Allergic Rhinitis
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Sep 2011
- Phase
- Observational
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Allergic rhinitis or allergic asthma, age 13+
Who may be able to join
- Allergic asthma or allergic rhinitis
- age 12+
Who cannot join
- smokers
Trial locations and contacts
1 site in 1 country.
United States1 site
Creighton University Medical Center
Omaha, Nebraska, 68131
About this study
Official title: The Effect of Montelukast In-vitro on Basophil Histamine and Leukotriene, IL-4 Adn IL-13 Release in Subjects With Allergic Rhinitis or Allergic Asthma
Subjects with either allergic asthma or allergic rhinitis will be recruited to obtain blood. This blood will be used to be stimulated with to whatever the patient allergic. In the laboratory, this stimulated blood will be measured for histamine, leukotrienes, IL-13 and IL-3. These are chemicals responsible for allergy symptoms.
- Conditions
- Allergic Asthma, Allergic Rhinitis
- Keywords
- IL13, leukotriene, histamine, IL4, Must be allergic asthma or allergic rhinitis
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Allergic Asthma | |
| 2 | Allergic Rhinitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histamine Release
Measured: during the assay portion.
Secondary outcomes (1)
Cytokine release. IL-13, IL-4 and leukotriene
Measured: assay portion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2008 (estimated)
- Study startMay 2008
- Primary completionSep 2011 (estimated)
- Study completionSep 2011 (estimated)
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00710450
- Sponsor's protocol ID
- Townley Merck
- Status last verified
- Sep 2011
- First submitted
- 1 Jul 2008
- Last updated
- 23 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Montelukast In-vitro on Basophil Histamine and Leukotriene, IL-4 Adn IL-13 Release in Subjects With Allergic Rhinitis or Allergic Asthma
- ClinicalTrials.gov ID
- NCT00710450
- Acronym / sponsor ID
- Townley Merck
- Conditions
- Allergic Asthma, Allergic Rhinitis
- Keywords
- IL13, leukotriene, histamine, IL4, Must be allergic asthma or allergic rhinitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- May 2008
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 4 Jul 2008 (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.
Subjects with either allergic asthma or allergic rhinitis will be recruited to obtain blood. This blood will be used to be stimulated with to whatever the patient allergic. In the laboratory, this stimulated blood will be measured for histamine, leukotrienes, IL-13 and IL-3. These are chemicals responsible for allergy symptoms.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Allergic Asthma |
| 2 | – | –Allergic Rhinitis |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Allergic rhinitis or allergic asthma, age 13+
Key inclusion criteria (2 listed)
- Allergic asthma or allergic rhinitis
- age 12+
Key exclusion criteria (1 listed)
- smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Histamine Release
Time frame: during the assay portion.
1 secondary outcome
Cytokine release. IL-13, IL-4 and leukotriene
Time frame: assay portion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Asthma and Allergic Rhinitis, run by Creighton University 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 2 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: status not confirmed, as of the sponsor's last update on 23 Sep 2011. 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.
Are results available for this study?
Results are not available in the source record.
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?
Histamine Release (time frame: during the assay portion.). 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 23 Sep 2011.