AsthmaNCT01026532
Functional Activity of Airway Eosinophils in Allergic Disease
An observational study of Asthma, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this study is to determine how a special white blood cell, the eosinophil, can contribute to asthma. One of the characteristics of asthma is airway inflammation. Airway inflammation in asthma may occur when an allergen is inhaled and sets up an allergic reaction in the bronchial tubes. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Asthma
- What is being tested?
- Segmental Allergen Challenge
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2011to 31 Mar 2017
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Well-controlled allergic subjects with mild-intermittent asthma will be identified and undergo inhaled allergen provocation to demonstrate an allergen-specific airway response.
Who may be able to join
- Age 18-50 years
- Diagnosis of allergic rhinitis and/or mild asthma
- Pre-albuterol forced expiratory volume in the first second (FEV1) of >70% predicted.
- Skin test positive to house dust mite (D. farinae), short ragweed or cat hair
- Documented negative Tuberculin skin test (PPD) within the last 12 months or a medical history that is consistent with a low probability of exposure to tuberculosis (i.e. the subject is not a health worker, has not traveled to endemic areas, and has no pre-existing medical or social risk factors for tuberculosis).
- At least a 20% decrease in FEV1 during the immediate response following inhaled antigen challenge
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- Safety laboratory assessments within normal ranges (labs to include complete blood count with differential, blood urea nitrogen, creatinine, Prothrombin time, Partial Thromboplastin Time and platelet count)
- Women of child-bearing potential (WCBP) must have a negative urine pregnancy test (urine HCG) within 48 hours of the methacholine challenge at Visit 2, within 48 hours of the inhaled allergen challenge at V3 and on the day of the segmental allergen challenge on Visit 5. WCBP must agree to use a reliable method of birth control for the duration of the study (reliable methods of birth control can include abstinence, barrier methods, oral contraceptives, injection contraceptives or skin absorption contraceptives).
- In the opinion of the investigator, capable and willing to grant written informed consent and cooperate with study procedures and requirements
Who cannot join
- Major health problems such as autoimmune disease, heart disease, type I and II diabetes, uncontrolled hypertension or lung diseases other than asthma. The listed health problems are definitive exclusion but decisions regarding major health problems not listed will be based upon the judgment of the investigator.
- No pre-existing chronic infectious disease.
- Any condition for which, in the opinion of the investigator, transient oxyhemoglobin desaturation is inadvisable.
- Pregnant or lactating females or has a planned pregnancy during the course of the study.
- Medication other than for asthma, allergies or contraception (e.g. monoamine oxidase inhibitors and beta-adrenergic antagonists in any form).
- Inhaled corticosteroids or oral corticosteroids within 1 month of screening.
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- Upper or lower respiratory infection within 1 month of screening.
- Unstable asthma as indicated by self report of increased symptoms or increased beta-agonist use over the 2 weeks preceding the screening visit.
- Current smokers (defined as smoked within the last year) or a former smoker with a history of >5 pack years.
- Obesity as defined by a Body Mass Index (BMI) >30.
- Use of an investigational drug within 30 days of entering the study
- History of noncompliance with medical regiments or subjects who are considered unreliable including those with a psychiatric history that, in the opinion of the investigator, may interfere with the conduct of study procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Univeristy of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
About this study
The purpose of this study is to determine how a special white blood cell, the eosinophil, can contribute to asthma. One of the characteristics of asthma is airway inflammation. Airway inflammation in asthma may occur when an allergen is inhaled and sets up an allergic reaction in the bronchial tubes. This reaction may lead to chest tightness, cough and wheeze. To better understand the way in which the eosinophil can cause inflammation, the investigators plan to study eosinophils that move in to the lung following an allergic reaction.
- Conditions
- Asthma
- Being tested
- Segmental Allergen Challenge
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Segmental Allergen ChallengeBiological
Segmental allergen challenge: Briefly, this procedure will be done during a bronchoscopy. Two airway tubes of the lung will have about 1 teaspoon of allergen put in it while the scope is wedged in an airway tube segment. The allergen will stimulate this portion of the airway tube to produce eosinophils. The scope will then be removed. The bronchoscopy will be repeated two days later to collect lung fluid and biopsy samples from the parts of the lung where the allergen solution was placed.
| Study group | Role | What they receive |
|---|---|---|
| Segmental antigen challenge | Segmental allergen challenge: Briefly, this procedure will be done during a bronchoscopy. Two airway tubes of the lung will have about 1 teaspoon of allergen put in it while the scope is wedged in an airway tube segment. The allergen will stimulate this portion of the airway tube to produce eosinophils. The scope will then be removed. The bronchoscopy will be repeated two days later to collect lung fluid and biopsy samples from the parts of the lung where the allergen solution was placed. Receives: Biological: Segmental Allergen Challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of this study is to use segmental antigen challenge by bronchoscopy to elicit airway eosinophilia and to retrieve cells from the airway for analysis of their function.
Measurement taken at 48 hours after segmental antigen challenge.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2009 (estimated)
- Study start24 Aug 2011
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
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.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01026532
- Sponsor's protocol ID
- 2014-1481
- Other IDs
- H-2009-0050, P01HL088594
- Status last verified
- Jan 2020
- First submitted
- 2 Dec 2009
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Activity of Airway Eosinophils in Allergic Disease
- ClinicalTrials.gov ID
- NCT01026532
- Acronym / sponsor ID
- 2014-1481
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 24 Aug 2011 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 4 Dec 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 how a special white blood cell, the eosinophil, can contribute to asthma. One of the characteristics of asthma is airway inflammation. Airway inflammation in asthma may occur when an allergen is inhaled and sets up an allergic reaction in the bronchial tubes. This reaction may lead to chest tightness, cough and wheeze. To better understand the way in which the eosinophil can cause inflammation, the investigators plan to study eosinophils that move in to the lung following an allergic reaction.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Segmental antigen challenge | – | Biological: Segmental Allergen ChallengeSegmental allergen challenge: Briefly, this procedure will be done during a bronchoscopy. Two airway tubes of the lung will have about 1 teaspoon of allergen put in it while the scope is wedged in an airway tube segment. The allergen will stimulate this portion of the airway tube to produce eosinophils. The scope will then be removed. The bronchoscopy will be repeated two days later to collect lung fluid and biopsy samples from the parts of the lung where the allergen solution was placed. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Well-controlled allergic subjects with mild-intermittent asthma will be identified and undergo inhaled allergen provocation to demonstrate an allergen-specific airway response.
Key inclusion criteria (9 listed)
- Age 18-50 years
- Diagnosis of allergic rhinitis and/or mild asthma
- Pre-albuterol forced expiratory volume in the first second (FEV1) of >70% predicted.
- Skin test positive to house dust mite (D. farinae), short ragweed or cat hair
- Documented negative Tuberculin skin test (PPD) within the last 12 months or a medical history that is consistent with a low probability of exposure to tuberculosis (i.e. the subject is not a health worker, has not traveled to endemic areas, and has no pre-existing medical or social risk factors for tuberculosis).
Key exclusion criteria (12 listed)
- Major health problems such as autoimmune disease, heart disease, type I and II diabetes, uncontrolled hypertension or lung diseases other than asthma. The listed health problems are definitive exclusion but decisions regarding major health problems not listed will be based upon the judgment of the investigator.
- No pre-existing chronic infectious disease.
- Any condition for which, in the opinion of the investigator, transient oxyhemoglobin desaturation is inadvisable.
- Pregnant or lactating females or has a planned pregnancy during the course of the study.
- Medication other than for asthma, allergies or contraception (e.g. monoamine oxidase inhibitors and beta-adrenergic antagonists in any form).
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 |
|---|---|---|
| Segmental Allergen ChallengeSegmental allergen challenge: Briefly, this procedure will be done during a bronchoscopy. Two airway tubes of the lung will have about 1 teaspoon of allergen put in it while the scope is wedged in an airway tube segment. The allergen will stimulate this portion of the airway tube to produce eosinophils. The scope will then be removed. The bronchoscopy will be repeated two days later to collect lung fluid and biopsy samples from the parts of the lung where the allergen solution was placed. | Biological | Segmental antigen challenge |
Primary outcome
The primary endpoint of this study is to use segmental antigen challenge by bronchoscopy to elicit airway eosinophilia and to retrieve cells from the airway for analysis of their function.
Time frame: 48 hours
Measurement taken at 48 hours after segmental antigen challenge.
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 18 Jan 2020.
- Individual participant dataSharing planned: Yes
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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 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 9 inclusion and 12 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 18 Jan 2020. 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?
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?
The primary endpoint of this study is to use segmental antigen challenge by bronchoscopy to elicit airway eosinophilia and to retrieve cells from the airway for analysis of their function. (time frame: 48 hours). 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 18 Jan 2020.