Small airway function differs in obese and non-obese asthmatic patients
ID
Bron
Verkorte titel
Aandoening
asthma, obesity
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
impulse oscillometry
Achtergrond van het onderzoek
Rationale: in asthma patients small airway dysfunction is associated with worse symptom control and higher number of exacerbations. Recent studies in obese asthmatic patients show that weight loss improves asthma symptoms and concurrent improvement in small airway function. This could be of clinical importance as extra-fine inhalation medication is available to target this compartment of the lung. However, no gold standard exists to assess small airway function and no study directly compared several tests of small airway function in asthmatic patients with or without obesity.
Objective: to compare small airway function in asthmatic patients with obesity to asthmatic patients without obesity
Study design: single center cross-sectional
Study population: 80 patients with asthma ≥6 months, with or without obesity
Main study parameters/endpoints: small airway function as tested by multiple pulmonary function tests.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This study includes three study visits at the Leiden University Medical Center. During the first visit participants will be subjected to measurement of vital signs, questionnaires will be filled out to obtain information regarding medical history and demography and blood will be drawn. Furthermore pulmonary function tests will be performed, distributed over visit one and two. Finally, sputum collection will take place at visit three.
Doel van het onderzoek
Small airway function differs in obese and non-obese asthmatic patients
Onderzoeksopzet
cross-sectional
Onderzoeksproduct en/of interventie
no intervention
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 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 (BMI <30)
Asthma was 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)
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• 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
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL5256 |
NTR-old | NTR5546 |
CCMO | NL54867.058.15 |
OMON | NL-OMON45982 |