Ex Vivo Effect of Surfactant Protein D on Pulmonary Cells in Patients With Asthma and Pilot Study… (NCT01378624) | Clinical Trial Compass
CompletedNot Applicable
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
Germany15 participantsStarted 2011-06
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* 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)
Exclusion C…
What they're measuring
1
Change in local inflammation
Timeframe: Baseline, 6 and 24 hours post segmental allergen challenge
2
Change of numbers of matured dendritic cells
Timeframe: Baseline and 24 h post segmental allergen challenge
Trial details
NCT IDNCT01378624
SponsorFraunhofer-Institute of Toxicology and Experimental Medicine