asthma, obesity
Conditions
Interventions
Observational study
Sponsors
Leiden University Medical Center, the Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: • Age ≥ 18 who have signed informed consent form prior to the start of the study • Clinical diagnosis for ≥ 6 months of asthma • Stable asthma: on a stable dose of asthma inhalation medication for at least 8 weeks prior to baseline visit • Obese (BMI >30) or non-obese (overweight (BMI 25 - 30) or normal weight (BMI < 25)) Asthma is defined according to the Global Initiative for Asthma 2015 guidelines as: - presence of symptoms and - an increase of ≥12% and 200mL in FEV1 after salbutamol or - a positive provocation test (methacholine PC20 <8 - 16mg/ml)
Exclusion criteria
Exclusion criteria: • Change of asthma inhalation medication in the past 8 weeks before visit 1 • Asthma exacerbation (defined as use of oral or intravenous corticosteroids and/or antibiotics) in the past 8 weeks before visit 1 • Smokers: current ≥ 10 cigarettes per day or ≥10 pack years • Diagnosis of COPD • Pregnancy, as reported by the participant • Clinical or functional uncontrolled respiratory- or other disease that might, in the judgement of the investigator, comprise the results or interpretation of the study • Current- or less than 1 month from baseline participation in interventional clinical trial with inhalation drugs • Inability to comply with study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective: to compare available tests for small airway function in asthmatic patients | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objectives: - Compare small airway function in obese and non-obese asthmatics - Compare small airway function in obese and non-obese asthmatics with good or poor symptom control as assessed by the Asthma Control Questionnaire (ACQ) - Assess the association of small airway function in obese and non-obese asthmatics with disease specific and general quality of life (mini Asthma Quality of Life Questionnaire (AQLQ)) - Assess the association of small airway function in obese and non-obese asthmatics with bronchial hyper-responsiveness (Bronchial Hyper-responsiveness Questionnaire (BHQ) and Methacholine provocation test) - Assess influence of concomitant pulmonary inhalation medication on small airway function in patients with asthma - Assess the association between medication adherence (8-item Morisky Medication Adherence Scal (MMAS-8)) and small airway function in obese and non-obese asthmatics - Compare small airway function in obese and non-obese asthmatics with high or low total blood IgE and eosinophils - Assess the association of history of asthma duration with small airway function | — |
Contacts
Public ContactT.N. Bonten
Albinusdreef 2
Outcome results
None listed