Allergic AsthmaNCT00507039
Safety and Repeatability of Bronchial Challenge With Grass-pollen
An observational study of Allergic Asthma, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
The study is meant to establish a one-step challenge with grass-pollen in patients sensitized for grass-pollen. Therefore the investigators compare a multi-step challenge with grass-pollen with an one-step challenge in order to survey the repeatability and safety. Read more about this study
- Who is it for?
- Ages 12 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Asthma
- What is being tested?
- inhalative grass-pollen provocation
- Type of treatment
- Surgery or procedure
- How many people
- 47 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2007to Dec 2009
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Subjects undergo allergen challenges with incremental doses of grass pollen allergen. In those subjects, who develop a fall in FEV1 of more than 20%, this is followed by two single-step challenges in an interval of at least seven days.
Who may be able to join
- age >12 <45 years
- known sensitization for grass-pollen
- informed consent
Who cannot join
- age <12 >45 years
- clinical asthma requiring regular inhalation
- vital capacity <80%
- FEV1 < 75%
- chronic disease conditions or infections
- pregnancy
Show all 9Show fewer
- inhalative or systemic steroid use
- substance abuse
- incapability of understanding the study's purpose and performance
Trial locations and contacts
1 site in 1 country.
Germany1 site
Goethe University, Department of Pulmonology
Frankfurt am Main, Hesse, 60590
About this study
Official title: Repeatability of a Single Concentration and Single-step Bronchial Allergen Challenge With Grass Pollen
The study is meant to establish a one-step challenge with grass-pollen in patients sensitized for grass-pollen. Therefore the investigators compare a multi-step challenge with grass-pollen with an one-step challenge in order to survey the repeatability and safety.
Read the detailed description
Background:
Specific provocation with inhaled allergens is an established tool in clinical practice and research, supporting the understanding of pathophysiology of allergic asthma, and analysing the efficacy of new therapies. This study examines the repeatability of a bolus-dose inhalative allergen challenge with grass pollen.
Method:
Forty grass pollen allergics should undergo an incremental-dose grass pollen challenge to calculate their PD20-dose. This calculated dose will be applicated twice to analyse the repeatability of the bolus dose challenge. Before and twenty-four hours after the provocation, exhaled nitric oxid (FeNO) will be determined as a marker of bronchial inflammation.
- Conditions
- Allergic Asthma
- Being tested
- inhalative grass-pollen provocation
- Keywords
- PD20 FEV1, grass pollen, one-step
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inhalative grass-pollen provocationProcedure or surgery
Also called Viasys APS, Allergopharma allergen
Subjects undergo allergen challenges with incremental doses of grass pollen allergen. In subjects, who develop a fall in FEV1 of more than 20%, this will be followed by two single-step challenges.
| Study group | Role | What they receive |
|---|---|---|
| grass allergy, bronchial challenge | subjects with known allergy against grass-pollen undergo bronchial challenges Receives: Procedure: inhalative grass-pollen provocation |
What is being measured
The primary outcome is the main question the study is designed to answer.
repeatability of a bolus-dose inhalative allergen challenge with grass pollen
Measured: feb 2007 - aug 2008
Secondary outcomes (1)
kappa-index of concordance: reliability of the three procedures titrated skin prick-test, incremental challenge and bolus challenge with grass pollen.
Measured: feb 2007 - dec 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study startFeb 2007
- Primary completionSep 2008
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johannes Schulze MD, Johann Wolfgang Goethe University Hospital
- Investigators
- Stefan Zielen, M.D., Ph.D, Principal investigator, Goethe University, Department of Pulmonology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00507039
- Sponsor's protocol ID
- 334/06/FFM
- Status last verified
- Oct 2011
- First submitted
- 23 Jul 2007
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cockcroft DW, Ruffin RE, Frith PA, Cartier A, Juniper EF, Dolovich J, Hargreave FE. Determinants of allergen-induced asthma: dose of allergen, circulating IgE antibody concentration, and bronchial responsiveness to inhaled histamine. Am Rev Respir Dis. 1979 Nov;120(5):1053-8. doi: 10.1164/arrd.1979.120.5.1053. No abstract available.
PubMed 507521Cockcroft DW, Murdock KY, Kirby J, Hargreave F. Prediction of airway responsiveness to allergen from skin sensitivity to allergen and airway responsiveness to histamine. Am Rev Respir Dis. 1987 Jan;135(1):264-7. doi: 10.1164/arrd.1987.135.1.264.
PubMed 3800152
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeatability of a Single Concentration and Single-step Bronchial Allergen Challenge With Grass Pollen
- ClinicalTrials.gov ID
- NCT00507039
- Acronym / sponsor ID
- 334/06/FFM
- Conditions
- Allergic Asthma
- Keywords
- PD20 FEV1, grass pollen, one-step
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 25 Jul 2007 (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 study is meant to establish a one-step challenge with grass-pollen in patients sensitized for grass-pollen. Therefore the investigators compare a multi-step challenge with grass-pollen with an one-step challenge in order to survey the repeatability and safety.
Detailed description
Background:
Specific provocation with inhaled allergens is an established tool in clinical practice and research, supporting the understanding of pathophysiology of allergic asthma, and analysing the efficacy of new therapies. This study examines the repeatability of a bolus-dose inhalative allergen challenge with grass pollen.
Method:
Forty grass pollen allergics should undergo an incremental-dose grass pollen challenge to calculate their PD20-dose. This calculated dose will be applicated twice to analyse the repeatability of the bolus dose challenge. Before and twenty-four hours after the provocation, exhaled nitric oxid (FeNO) will be determined as a marker of bronchial inflammation.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| grass allergy, bronchial challenge | – | Procedure: inhalative grass-pollen provocationsubjects with known allergy against grass-pollen undergo bronchial challenges |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Subjects undergo allergen challenges with incremental doses of grass pollen allergen. In those subjects, who develop a fall in FEV1 of more than 20%, this is followed by two single-step challenges in an interval of at least seven days.
Key inclusion criteria (3 listed)
- age >12 <45 years
- known sensitization for grass-pollen
- informed consent
Key exclusion criteria (9 listed)
- age <12 >45 years
- clinical asthma requiring regular inhalation
- vital capacity <80%
- FEV1 < 75%
- chronic disease conditions or infections
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 |
|---|---|---|
| inhalative grass-pollen provocationAlso: Viasys APS, Allergopharma allergenSubjects undergo allergen challenges with incremental doses of grass pollen allergen. In subjects, who develop a fall in FEV1 of more than 20%, this will be followed by two single-step challenges. | Procedure or surgery | grass allergy, bronchial challenge |
Primary outcome
repeatability of a bolus-dose inhalative allergen challenge with grass pollen
Time frame: feb 2007 - aug 2008
1 secondary outcome
kappa-index of concordance: reliability of the three procedures titrated skin prick-test, incremental challenge and bolus challenge with grass pollen.
Time frame: feb 2007 - dec 2007
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 12 Oct 2011.
- Background: PubMed 507521Cockcroft DW, Ruffin RE, Frith PA, Cartier A, Juniper EF, Dolovich J, Hargreave FE. Determinants of allergen-induced asthma: dose of allergen, circulating IgE antibody concentration, and bronchial responsiveness to inhaled histamine. Am Rev Respir Dis. 1979 Nov;120(5):1053-8. doi: 10.1164/arrd.1979.120.5.1053. No abstract available.
- Background: PubMed 3800152Cockcroft DW, Murdock KY, Kirby J, Hargreave F. Prediction of airway responsiveness to allergen from skin sensitivity to allergen and airway responsiveness to histamine. Am Rev Respir Dis. 1987 Jan;135(1):264-7. doi: 10.1164/arrd.1987.135.1.264.
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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.
Stefan Zielen, M.D., Ph.D principal investigator
Goethe University, Department of Pulmonology
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, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
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 3 inclusion and 9 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 12 Oct 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 Germany. 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?
repeatability of a bolus-dose inhalative allergen challenge with grass pollen (time frame: feb 2007 - aug 2008). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00507039, which also lists 2 linked publications.
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 12 Oct 2011.