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van CCT (UK)

van CCT (UK)

Autoimmunity in Chronic Obstructive Pulmonary Disease.

- candidate number7874
- NTR NumberNTR2259
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-mrt-2010
- Secondary IDs3.2.08.021 Dutch Asthma Foundation
- Public TitleAutoimmunity in Chronic Obstructive Pulmonary Disease.
- Scientific TitleAutoimmunity in Chronic Obstructive Pulmonary Disease.
- hypothesisChronic Obstructive Pulmonary Disease is a disease of the lungs for which adequate treatment lacks. We hypothesize that there is a role for autoimmunity in this disease.
- Healt Condition(s) or Problem(s) studiedChronic Obstructive Pulmonary Disease (COPD), Smoking, Lung, Autoimmunity, Cytotoxity, Antibodies
- Inclusion criteriaInclusion criteria for COPD patients:
1. Clinical diagnose of COPD;
2. No allergies;
3. Post-bronchodilator FEV1 < 80% predicted, and postbronchodilator FEV1/FVC < 70% (in accordance with the GOLD stages mentioned above);
4. Age > 40;
5. Current or ex-smokers > 10 pack years;
6. Ex-smokers have to have quitted smoking for at least one year;
7. No other major current health problems;
8. Written informed consent.

Healthy controls:
1. No signs of pulmonary disease;
2. No allergies;
3. No other major current health problems;
4. FEV1 > 90 % predicted and FEV1/FVC > 70%;
5. Age > 40;
6. Never smokers, i.e. no cigarettes last year, and < 5 pack years, or current smokers > 10 pack years; or ex- smokers for > 1 year and > 10 pack years;
7. Written informed consent.
- Exclusion criteria1. Addiction to alcohol or drugs;
2. COPD exacerbation in the 6 weeks preceding the study;
3. Immunosuppressive therapy.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-apr-2010
- planned closingdate1-apr-2011
- Target number of participants120
- InterventionsN/A
- Primary outcome1. The degree of autoantibody-mediated cytotoxicity of sera of COPD patients when compared to non-COPD patients, expressed as a fraction of cells that have died during incubation;
2. The cell types (primary bronchial epithelial cells, primary airway smooth muscle cells, primary lung fibroblasts) and cell lines (an alveolar epithelial cell line and a lung fibroblast cell line) that are primarily affected by autoantibodies as found in serum of COPD patients and healthy controls;
3. The contribution of complement, different effector cells, and antibody-free serum to the level (as outlined in the previous paragraphs) and specificity of cytotoxicity (which cells and cell lines are affected). The impact of different effector cells and antibody-free serum.
- Secondary outcome1. Effects of age, aspects of smoking history, clinical and immunological parameters on cytotoxicity;
2. Insight into the components which play a role in lung remodelling and destruction. We expect that results will lead to more attention for COPD and more focus on relevant targets in drug development programs;
3. A better understanding of the mechanisms underlying the pathological changes in lungs of patients with COPD, and identification of characteristics of patients which may benefit from anti-autoimmune therapy. This is necessary to be able to develop more targeted drug development programs and to develop efficient therapies;
4. Due to the similarities of COPD to other autoimmune disease (outlined above), opportunities for improved treatment and medication may in part be based on regimes used in other autoimmune diseases.
- TimepointsN/A
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
Dutch Asthma Foundation (Nederlands Astma Fonds)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD25-mrt-2010 - 13-apr-2011

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