Mild Intermittent Asthma (Gina 1)NCT01378624
Ex Vivo Effect of Surfactant Protein D on Pulmonary Cells in Patients With Asthma and Pilot Study to Assess Local Inflammation Induced by Segmental Allergen Challenge by Magnetic Resonance Imaging
A study testing Bronchoscopy in people with Mild Intermittent Asthma (Gina 1), run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 1 site in Germany.
Trial summary
Ex vivo effect of fragments and modified forms of surfactant protein D on pulmonary immune cells derived from bronchoalveolar lavage after segmental allergen challenge in patients with asthma and pilot study to assess local inflammation induced by segmental allergen challenge by magnetic resonance imaging. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Intermittent Asthma (Gina 1)
- What is being tested?
- Bronchoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2011to Oct 2012
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able and willing to give written informed consent
- Physician diagnosis of mild asthma according to GINA guidelines (1;7)
- Nonsmokers with a history of less than 1 pack a year having been nonsmokers for at least the last five years
- FEV1 80% of predicted
- Positive skin prick test for grass mix or D. pteronyssinus at or within 12 months prior to the screening visit
- Positive response to an incremental inhaled allergen challenge with house dust mite allergen or grass pollen allergen
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- Women will be considered for inclusion if they are:
- Not pregnant, as confirmed by pregnancy test, and not nursing
- Of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal, with documented proof of hysterectomy or tubal ligation, or meet clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit)o of childbearing potential and using a highly effective method of contraception during the entire study (vasectomized partner, sexual abstinence
- The lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the study until at least 72 hours after the end of the study
- Implants, injectables, combined oral contraceptives, hormonal IUDs, or double barrier methods (i.e. any double combination of IUD, condom with spermicidal gel,diaphragm, sponge, and cervical cap)
Who cannot join
- History of upper or lower respiratory tract infection four weeks prior to the informed consent visit
- 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, psychiatric disease, endocrine disease, infectious disease, inflammatory disease, or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
- Clinically significant pathological findings in safety laboratory tests
- Regular intake of any medication other than short acting inhaled beta agonists, paracetamol for pain relief, birth control medication, hormonal replacement therapy, dietary and vitamin supplements
- Specific Immunotherapy (SIT) within two years prior to the study
- Use of anti-inflammatory medication including systemic or inhaled corticosteroid within the last four weeks
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- Any history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures.
- Suspected hypersensitivity to any ingredients of the medication in line with bronchoscopy (bronchodilators, sedatives and local anesthetics)
- Conditions or factors, which would make the subject unlikely to be able to undergo bronchoscopy or incremental allergen challenge
- Conditions or factors, which would make the subject unable to undergo MRI such as metal containing implants, remainders of shell splinters or bullets, or claustrophobia.
- History of drug or alcohol abuse
- Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study.
- Participation in a clinical trial 30 days prior to enrollment
- Segmental allergen challenge three months prior to treatment
- Risk of non-compliance with study procedures
- Calculated GFR <30 ml/min/1.73 m2
- Known allergy to MRI based contrast agents
- Donation of more than 500 ml of blood in the preceding 9 weeks before the trial examination
- Hb Hemoglobin below lower limit of normal value
- Additional Inclusion Criteria for healthy control subjects:
- Healthy subjects with no clinical evidence of allergic rhinitis and respiratory disease (e.g. asthma)
- Negative skin prick test for grass mix or D. pteronyssinus at or within 12 months prior to the screening visit
- Negative response to an incremental metacholine challenge (PC20 ≥ 8mg/ml)
- Total IgE (Immunglobulin E) <100 IU/ml
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ex Vivo Effect of Fragments and Modified Forms of Surfactant Protein D on Pulmonary Immune Cells Derived From Bronchoalveolar Lavage After Segmental Allergen Challenge in Patients With Asthma and Pilot Study to Assess Local Inflammation Induced by Segmental Allergen Challenge by Magnetic Resonance Imaging
Ex vivo effect of fragments and modified forms of surfactant protein D on pulmonary immune cells derived from bronchoalveolar lavage after segmental allergen challenge in patients with asthma and pilot study to assess local inflammation induced by segmental allergen challenge by magnetic resonance imaging.
Read the detailed description
The effect of surfactant protein D under native and altered conditions will be investigated in immune cells that are derived from bronchoalveolar lavage in patients with allergic asthma following segmental allergen challenge. The goal of this study is to elucidate the pro- versus anti-inflammatory function of SP-D molecules and to identify motifs of SP-D that have treatment potential in allergic asthma and to assess local inflammation induced by segmental allergen challenge by magnetic resonance imaging.
In addition to the patients with allergic asthma a subgroup of five healthy subjects will be included into the study to elucidate the specificity of the SP-D (surfactant protein-D) effect on the allergic inflammation in the invitro models.
The primary objective of this study is to isolate BAL cells for different invitro experiments and to assess local inflammation after segmental allergen challenge by MRI in response to the applied allergen dose.
Therefore, following a baseline BAL, allergen (2× individual dose, 1× one tenth of individual dose) and saline (1×) will be instilled into four different lung segments during a first bronchoscopy. After 24 hours during a second bronchoscopy BAL will be collected in these challenged segments to harvest invaded cells for invitro experimentation. In addition, bronchial biopsies and epithelial brushes will be taken to assess the degree of local inflammation in bronchial mucosa and to study the activation of airway epithelium following allergen challenge.
- Conditions
- Mild Intermittent Asthma (Gina 1)
- Being tested
- Bronchoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BronchoscopyOther
In brief, during the first bronchoscopy a baseline BAL and baseline endobronchial brush and forceps biopsies will be obtained and allergen as well as saline (control segment) will be instilled.
The subjects will undergo a second bronchoscopy in order to obtain BAL from the allergen challenged segments and the saline challenged segment, and endobronchial forceps biopsies.
| Study group | Role | What they receive |
|---|---|---|
| Bronchoscopy | Experimental | Not described Receives: Other: Bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in local inflammation
Magnetic resonance imaging to assess local inflammation prior to as well as 6 h and 24 h after segmental allergen challenge
Measured: Baseline, 6 and 24 hours post segmental allergen challenge
Change of numbers of matured dendritic cells
Change of numbers of matured dendritic cells in vitro in the absence and presence of surfactant protein D.
Measured: Baseline and 24 h post segmental allergen challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Intermittent Asthma (Gina 1)Studies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Hannover Medical School
- Investigators
- Jens Hohlfeld, MD, Professor, Principal investigator, Fraunhofer ITEM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01378624
- Sponsor's protocol ID
- 10-07 ZAP2
- Status last verified
- Oct 2013
- First submitted
- 17 Jun 2011
- Last updated
- 31 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ex Vivo Effect of Fragments and Modified Forms of Surfactant Protein D on Pulmonary Immune Cells Derived From Bronchoalveolar Lavage After Segmental Allergen Challenge in Patients With Asthma and Pilot Study to Assess Local Inflammation Induced by Segmental Allergen Challenge by Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT01378624
- Acronym / sponsor ID
- 10-07 ZAP2
- Conditions
- Mild Intermittent Asthma (Gina 1)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental MedicineUniversity, hospital or other
- Collaborators
- Hannover Medical School
- Study start
- Jun 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 22 Jun 2011 (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.
Ex vivo effect of fragments and modified forms of surfactant protein D on pulmonary immune cells derived from bronchoalveolar lavage after segmental allergen challenge in patients with asthma and pilot study to assess local inflammation induced by segmental allergen challenge by magnetic resonance imaging.
Detailed description
The effect of surfactant protein D under native and altered conditions will be investigated in immune cells that are derived from bronchoalveolar lavage in patients with allergic asthma following segmental allergen challenge. The goal of this study is to elucidate the pro- versus anti-inflammatory function of SP-D molecules and to identify motifs of SP-D that have treatment potential in allergic asthma and to assess local inflammation induced by segmental allergen challenge by magnetic resonance imaging.
In addition to the patients with allergic asthma a subgroup of five healthy subjects will be included into the study to elucidate the specificity of the SP-D (surfactant protein-D) effect on the allergic inflammation in the invitro models.
The primary objective of this study is to isolate BAL cells for different invitro experiments and to assess local inflammation after segmental allergen challenge by MRI in response to the applied allergen dose.
Therefore, following a baseline BAL, allergen (2× individual dose, 1× one tenth of individual dose) and saline (1×) will be instilled into four different lung segments during a first bronchoscopy. After 24 hours during a second bronchoscopy BAL will be collected in these challenged segments to harvest invaded cells for invitro experimentation. In addition, bronchial biopsies and epithelial brushes will be taken to assess the degree of local inflammation in bronchial mucosa and to study the activation of airway epithelium following allergen challenge.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bronchoscopy | Experimental | Other: Bronchoscopy |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Able and willing to give written informed consent
- Physician diagnosis of mild asthma according to GINA guidelines (1;7)
- Nonsmokers with a history of less than 1 pack a year having been nonsmokers for at least the last five years
- FEV1 80% of predicted
- Positive skin prick test for grass mix or D. pteronyssinus at or within 12 months prior to the screening visit
Key exclusion criteria (24 listed)
- History of upper or lower respiratory tract infection four weeks prior to the informed consent visit
- 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, psychiatric disease, endocrine disease, infectious disease, inflammatory disease, or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
- Clinically significant pathological findings in safety laboratory tests
- Regular intake of any medication other than short acting inhaled beta agonists, paracetamol for pain relief, birth control medication, hormonal replacement therapy, dietary and vitamin supplements
- Specific Immunotherapy (SIT) within two years prior to the study
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 |
|---|---|---|
| BronchoscopyIn brief, during the first bronchoscopy a baseline BAL and baseline endobronchial brush and forceps biopsies will be obtained and allergen as well as saline (control segment) will be instilled. The subjects will undergo a second bronchoscopy in order to obtain BAL from the allergen challenged segments and the saline challenged segment, and endobronchial forceps biopsies. | Other | Bronchoscopy |
Primary outcome
Change in local inflammation
Time frame: Baseline, 6 and 24 hours post segmental allergen challenge
Magnetic resonance imaging to assess local inflammation prior to as well as 6 h and 24 h after segmental allergen challenge
Change of numbers of matured dendritic cells
Time frame: Baseline and 24 h post segmental allergen challenge
Change of numbers of matured dendritic cells in vitro in the absence and presence of surfactant protein D.
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 31 Oct 2013.
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, Professor 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 in people with Mild Intermittent Asthma (Gina 1), 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 11 inclusion and 24 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 31 Oct 2013. 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?
Change in local inflammation (time frame: Baseline, 6 and 24 hours post segmental allergen challenge). The study lists 2 primary outcomes in all. 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 31 Oct 2013.