Status:
UNKNOWN
Role of Extracellular Matrix in the Development of Airway Remodeling in Asthma
Lead Sponsor:
Lithuanian University of Health Sciences
Collaborating Sponsors:
Research Council of Lithuania
University of Groningen
Conditions:
Allergic Asthma
Airway Remodelling
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
Asthma is a major noncommunicable chronic inflammatory disorder which is characterized by airway inflammation and related to pathological modifications of the bronchial wall structure so called airway...
Detailed Description
Asthma is a major noncommunicable chronic inflammatory disorder which is characterized by airway inflammation and related to pathological modifications of the bronchial wall structure so called airway...
Eligibility Criteria
Inclusion
- Men and women between the ages of 18-50 years;
- Allergic asthma and sensitization to house dust mites (D. pteronyssinus) allergen, approved with:
- 2\. 1. Medical history and symptoms more than one year and 2.2. skin prick test positive for D. pteronyssinus (positive wheals are those exceeding 3mm in diameter greater than the negative control) and 2.3. Positive bronchial challenge with methacholine or documented completely reversible bronchial obstruction; 3. Stable lung function (FEV1≥70 perc.); 4. Postmenopausal women. Premenopausal women if pregnancy test is negative and they agree to use an effective contraceptive measures during the study; 5. Healthy subjects without allergic and other chronic respiratory diseases (control group); 6. Non- smokers; 7. Participants who gave his/her informed written consent.
Exclusion
- Asthma exacerbation 1 month prior to study
- Clinically significant permanent allergy symptoms (ex. cat or dog dander induced allergy)
- Contraindications to perform an allergy skin test and/or bronchial provocation test 3.1. Active airway infection 1 month prior the study; 3.2. Used medicaments: 3.2.1. Inhaled glucocorticoids intake 1 month prior the study; 3.2.2. Antihistamines intake 7 days prior the study; 3.2.3. Short acting β2 agonists 12 hours prior the study; 3.2.4. Long acting β2 agonists 2 days prior the study; 3.2.5. Leukotriene receptor antagonists prior 14 days;
- If the histamine mean wheal diameter is \<= 3 mm or control mean wheal diameter is \>= 3 mm;
- Contraindications for epinephrine;
- Other significant mental and / or internal diseases and conditions, which could be as exclusion criteria due to the opinion of the researcher;
- Alcohol or narcotic abuse;
- Pregnancy;
- Breast-feeding.
Key Trial Info
Start Date :
June 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 8 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03388359
Start Date
June 1 2017
End Date
December 8 2020
Last Update
September 7 2020
Active Locations (1)
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1
Lithuanian University of Health Sciences, Pulmonology Department
Kaunas, Lithuania, LT-50009