Bronchial HyperreactivityNCT00519740
Influence of Nutrition on Nasal and Bronchial Affliction in Patients With Allergy on Grass-Pollen
A study testing inhalative specific bronchial provocation with grass-pollen in people with Bronchial Hyperreactivity and Hypersensitivity, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
The study is meant to observe the influence of nutrition on nasal and bronchial discomfort in patients with allergy on grass pollen after specific bronchial provocation. Therefore, the investigators will record the patients' nutrition habits and measure the blood level of long chained polyunsaturated fatty-acids. Read more about this study
- Who is it for?
- Ages 12 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchial Hyperreactivity, Hypersensitivity, Allergy
- What is being tested?
- inhalative specific bronchial provocation with grass-pollen
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2006to Dec 2008
- Phase
- Interventional
- 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
Who may be able to join
- age >12 and <45 years
- informed consent
- Known allergy on grass-pollen
Who cannot join
- age <12 and >45 years
- Clinical asthma requiring regular inhalation
- vital capacity >80%
- FEV1 < 75%
- Chronic disease
- 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: Influence of Nutrition on Nasal and Bronchial Affliction in Patients With Allergy on Grass-Pollen After Low-Dosed Specific Bronchial Provocation
The study is meant to observe the influence of nutrition on nasal and bronchial discomfort in patients with allergy on grass pollen after specific bronchial provocation. Therefore, the investigators will record the patients' nutrition habits and measure the blood level of long chained polyunsaturated fatty-acids.
- Conditions
- Bronchial Hyperreactivity, Hypersensitivity, Allergy, Bronchial Asthma
- Being tested
- inhalative specific bronchial provocation with grass-pollen
- Keywords
- grass-pollen, allergy, bronchial hyperreactivity, asthma
- Medical subject headings
- Bronchial Hyperreactivity, Hypersensitivity, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inhalative specific bronchial provocation with grass-pollenOther
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation of the blood fatty-acid level and bronchial hyperreactivity, measured as the exhaled NO.
Measured: aug 2006 - feb 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2007 (estimated)
- Study startAug 2006
- Primary completionAug 2008
- Study completionDec 2008
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 Bronchial HyperreactivityStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Stefan Zielen, M.D., Ph.D., Principal investigator, Goethe University, Department of Pulmonology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00519740
- Sponsor's protocol ID
- 214/06/FFM
- Status last verified
- Feb 2009
- First submitted
- 22 Aug 2007
- Last updated
- 4 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dyerberg J, Bang HO. Lipid metabolism, atherogenesis, and haemostasis in Eskimos: the role of the prostaglandin-3 family. Haemostasis. 1979;8(3-5):227-33. doi: 10.1159/000214314.
PubMed 511010Kitz R, Rose MA, Schubert R, Beermann C, Kaufmann A, Bohles HJ, Schulze J, Zielen S. Omega-3 polyunsaturated fatty acids and bronchial inflammation in grass pollen allergy after allergen challenge. Respir Med. 2010 Dec;104(12):1793-8. doi: 10.1016/j.rmed.2010.06.019. Epub 2010 Jul 15.
PubMed 20637584
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Nutrition on Nasal and Bronchial Affliction in Patients With Allergy on Grass-Pollen After Low-Dosed Specific Bronchial Provocation
- ClinicalTrials.gov ID
- NCT00519740
- Acronym / sponsor ID
- 214/06/FFM
- Conditions
- Bronchial Hyperreactivity, Hypersensitivity, Allergy, Bronchial Asthma
- Keywords
- grass-pollen, allergy, bronchial hyperreactivity, asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 23 Aug 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 observe the influence of nutrition on nasal and bronchial discomfort in patients with allergy on grass pollen after specific bronchial provocation. Therefore, the investigators will record the patients' nutrition habits and measure the blood level of long chained polyunsaturated fatty-acids.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- age >12 and <45 years
- informed consent
- Known allergy on grass-pollen
Key exclusion criteria (9 listed)
- age <12 and >45 years
- Clinical asthma requiring regular inhalation
- vital capacity >80%
- FEV1 < 75%
- Chronic disease
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 specific bronchial provocation with grass-pollen | Other | – |
Primary outcome
correlation of the blood fatty-acid level and bronchial hyperreactivity, measured as the exhaled NO.
Time frame: aug 2006 - feb 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 4 Feb 2009.
- Results publication: PubMed 511010Dyerberg J, Bang HO. Lipid metabolism, atherogenesis, and haemostasis in Eskimos: the role of the prostaglandin-3 family. Haemostasis. 1979;8(3-5):227-33. doi: 10.1159/000214314.
- Derived from this study: PubMed 20637584Kitz R, Rose MA, Schubert R, Beermann C, Kaufmann A, Bohles HJ, Schulze J, Zielen S. Omega-3 polyunsaturated fatty acids and bronchial inflammation in grass pollen allergy after allergen challenge. Respir Med. 2010 Dec;104(12):1793-8. doi: 10.1016/j.rmed.2010.06.019. Epub 2010 Jul 15.
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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?
A study testing inhalative specific bronchial provocation with grass-pollen in people with Bronchial Hyperreactivity and Hypersensitivity, 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 4 Feb 2009. 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?
correlation of the blood fatty-acid level and bronchial hyperreactivity, measured as the exhaled NO. (time frame: aug 2006 - feb 2007). 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 NCT00519740, 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 4 Feb 2009.