AtopyNCT00295737
Effect of an Immunotoxin on Activated Human Macrophages in Those With Allergic Rhinitis or Mild Intermittent Asthma
A study testing bronchoscopy, allergen/endotoxin instillation in people with Atopy and Rhinitis, run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 1 site in Germany.
Trial summary
The primary objective of this study is to isolate macrophages by using bronchoalveolar lavage (BAL) for different in vitro experiments. Therefore, following a baseline BAL, allergen, endotoxin, and saline will be instilled into three different lung segments during the first bronchoscopy. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Atopy, Rhinitis, Bronchial Asthma
- What is being tested?
- bronchoscopy, allergen/endotoxin instillation
- Type of treatment
- Surgery or procedure
- How many people
- 8 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2006to Jan 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Physician diagnosis of atopy (allergic rhinitis or mild intermittent asthma)
- Age 18-55 years
- Nonsmoker (> 5 years)
- Forced expiratory volume in 1 second (FEV1) > 70% of the predicted value
- A positive skin prick test for grass mix or D. pteronyssinus at or within 12 months prior to the screening visit
- Informed consent
- Females with negative pregnancy test
Who cannot join
- Infections of the respiratory tract within the last month
- Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
- Pathological findings in blood tests (differential blood count, blood clotting, electrolytes, liver enzymes, retention parameters)
- Subject is undergoing allergen desensitization therapy
- Permanent medication
- Systemic or inhaled corticosteroid use within the last month
Show all 11Show fewer
- Anti-inflammatory medication within the last month
- Pregnancy
- Neurological or psychiatric disease or history of drug or alcohol abuse which would interfere with the subject's proper completion of the protocol assignment
- There is a risk of non-compliance with study procedures
- Participation in a clinical trial 30 days prior to enrolment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 05/04 IMHOTEP-1 FHG: Ex Vivo Effect of an Immunotoxin on Activated Human Macrophages From Atopics After Segmental Instillation of Allergen and Endotoxin
The primary objective of this study is to isolate macrophages by using bronchoalveolar lavage (BAL) for different in vitro experiments.
Therefore, following a baseline BAL, allergen, endotoxin, and saline will be instilled into three different lung segments during the first bronchoscopy. After 24 hours during a second bronchoscopy, BAL fluid will be collected in these challenged segments to harvest invaded cells for in vitro experimentation. In addition, segmental bronchial biopsies will be taken to assess the degree of local inflammation.
- Conditions
- Atopy, Rhinitis, Bronchial Asthma
- Being tested
- bronchoscopy, allergen/endotoxin instillation
- Keywords
- allergic rhinitis
- Medical subject headings
- Rhinitis, Asthma, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bronchoscopy, allergen/endotoxin instillationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
number of macrophages in bronchoalveolar lavage
Measured: one day after challenge
Secondary outcomes (1)
number of other BAL cells
Measured: one day after challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completionJan 2008
- Study completionJan 2008
Why it stopped: proof of mechanism achieved with fewer subjects than anticipated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtopyStudies 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Jens Hohlfeld, MD, Principal investigator, Fraunhofer ITEM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00295737
- Sponsor's protocol ID
- 05/04 IMHOTEP-1 FHG
- Status last verified
- Jan 2008
- First submitted
- 22 Feb 2006
- Last updated
- 16 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 05/04 IMHOTEP-1 FHG: Ex Vivo Effect of an Immunotoxin on Activated Human Macrophages From Atopics After Segmental Instillation of Allergen and Endotoxin
- ClinicalTrials.gov ID
- NCT00295737
- Acronym / sponsor ID
- 05/04 IMHOTEP-1 FHG
- Conditions
- Atopy, Rhinitis, Bronchial Asthma
- Keywords
- allergic rhinitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: proof of mechanism achieved with fewer subjects than anticipated
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental MedicineUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 24 Feb 2006 (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 primary objective of this study is to isolate macrophages by using bronchoalveolar lavage (BAL) for different in vitro experiments.
Therefore, following a baseline BAL, allergen, endotoxin, and saline will be instilled into three different lung segments during the first bronchoscopy. After 24 hours during a second bronchoscopy, BAL fluid will be collected in these challenged segments to harvest invaded cells for in vitro experimentation. In addition, segmental bronchial biopsies will be taken to assess the degree of local inflammation.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Physician diagnosis of atopy (allergic rhinitis or mild intermittent asthma)
- Age 18-55 years
- Nonsmoker (> 5 years)
- Forced expiratory volume in 1 second (FEV1) > 70% of the predicted value
- A positive skin prick test for grass mix or D. pteronyssinus at or within 12 months prior to the screening visit
Key exclusion criteria (11 listed)
- Infections of the respiratory tract within the last month
- Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
- Pathological findings in blood tests (differential blood count, blood clotting, electrolytes, liver enzymes, retention parameters)
- Subject is undergoing allergen desensitization therapy
- Permanent medication
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 |
|---|---|---|
| bronchoscopy, allergen/endotoxin instillation | Procedure or surgery | – |
Primary outcome
number of macrophages in bronchoalveolar lavage
Time frame: one day after challenge
1 secondary outcome
number of other BAL cells
Time frame: one day after challenge
Results and safety
The study was stopped early (reason given: proof of mechanism achieved with fewer subjects than anticipated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2008.
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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.
Jens Hohlfeld, MD principal investigator
Fraunhofer ITEM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bronchoscopy, allergen/endotoxin instillation in people with Atopy and Rhinitis, run by Fraunhofer-Institute of Toxicology and Experimental Medicine 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 7 inclusion and 11 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: stopped early, as of the sponsor's last update on 16 Jan 2008. 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 was stopped early (reason given: proof of mechanism achieved with fewer subjects than anticipated). 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?
number of macrophages in bronchoalveolar lavage (time frame: one day after challenge). 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 16 Jan 2008.