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Kleine luchtweg functie bij astma en overgewicht


- candidate number27072
- NTR NumberNTR6394
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-apr-2017
- Secondary IDsP15.293  METC Leiden
- Public TitleKleine luchtweg functie bij astma en overgewicht
- Scientific TitleSmall Airway function iN obesiTy ANd Asthma study
- ACRONYMSANTANA
- hypothesisThe aims of the current study are to compare available tests for small airway function in asthmatic patients and to assess differences in small airway function between obese and non-obese asthmatic patients
- Healt Condition(s) or Problem(s) studiedAsthma, Obesity
- 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 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-apr-2017
- planned closingdate1-sep-2018
- Target number of participants90
- InterventionsObservational study
- Primary outcomePrimary Objective: to compare available tests for small airway function in asthmatic patients
- Secondary outcomeSecondary 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
- Timepoints3
- Trial web siten.a.
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. T.N. Bonten
- CONTACT for SCIENTIFIC QUERIESDr. T.N. Bonten
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Chiesi Pharmaceuticals
- Publications
- Brief summaryRationale: 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: 90 patients with asthma ≥6 months, with obesity or without obesity (overweight and normal weight).
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.
- Main changes (audit trail)
- RECORD10-apr-2017 - 21-jun-2017


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