Status:
COMPLETED
General Risk Factors and Inflammatory Determinants in Older Patients With Asthma
Lead Sponsor:
Gerdien Tramper
Conditions:
Asthma
Late-Onset Asthma
Eligibility:
All Genders
18-80 years
Brief Summary
A cross-sectional study in asthma patients to determine if a late age of onset asthma (start symptoms \>18 years old), is associated with more persistent airway/systemic inflammation, worse asthma con...
Detailed Description
For ages, asthma has been considered a disease for children and young adults. However, nowadays 30% of all asthma patients is over 50 years old. Asthma in the elderly is generally more severe and appr...
Eligibility Criteria
Inclusion
- Inclusion Criteria Asthma patients:
- Age between 18-80 years
- Smoking history of \< 10 packyears (PY)
- Willing and able to comply with the study protocol
- Asthma diagnosis is based on presence of typical clinical symptoms, reversible airway obstruction (+12% improvement in forced expiratory volume at one second (FEV1) after bronchodilator) or bronchial hyperreactivity (PC20 \< 8 mg/ml) or a (fractional exhaled nitric oxide) FeNO \> 50 ppb. - All asthma patients have (Global Initiative for Asthma ) GINA step 4-5 medication (high dose ICS/LABA).
- Asthma control questionaire (ACQ) \> 0,75
- Written informed consent.
- Inclusion Criteria Healthy controls:\\Inclusion criteria healthy control:
- Written informed consent
- Age between 18-80 years.
- Exclusion Criteria:
- Smoking history of \> 10 PY
- Age \< 18 years or \> 80 years
- Not able to speak or write Dutch language.
- Not able to perform lung function test/sputum induction
- ACQ \< 0,75
- Other diseases which could influence pulmonary function and/or the immune system such as: o A possible infection of the upper- or lower respiratory tract 4 weeks prior to the collection of materials;
- Chronic obstructive pulmonary disorder (COPD) in the medical history;
- Auto-immune diseases such as systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), myasthenia gravis or Goodpasture's syndrome;
- Malignancies;
- Inherited or acquired immunodeficiency
- Pregnancy;
- Exclusion criteria healthy controls:
- Asthma, as defined earlier (page 13);
- An abnormal spirometry with a forced vital capacity (FVC) or FEV1 below the 80% of the predicted value
- A liaison with the coordinating or principal investigator, which could likely influence the decision to participate in this study voluntarily (in concordance with the World Meteorological Organization (WMO) -article 5);
Exclusion
Key Trial Info
Start Date :
May 8 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03278561
Start Date
May 8 2017
End Date
December 31 2019
Last Update
August 14 2020
Active Locations (1)
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1
Franciscus Gasthuis
Rotterdam, South Holland, Netherlands, 3045PM