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van CCT (UK)

van CCT (UK)

Small Airway function in obesity and asthma study

- candidate number22954
- NTR NumberNTR5546
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-okt-2015
- Secondary IDsNL54867.058.15 
- Public TitleSmall Airway function in obesity and asthma study
- Scientific TitleSmall Airway function in obesity and asthma study
- hypothesisSmall airway function differs in 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 (BMI <30)

Asthma was defined according to the Global Initiative for Asthma 2015 guidelines as:
- presence of symptoms
- 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 receivedno
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-jan-2016
- planned closingdate1-jan-2017
- Target number of participants80
- Interventionsno intervention
- Primary outcomeimpulse oscillometry
- Secondary outcome- other measurements of small airway function
- blood eosinophil count and total IgE
- sputum eosinophil count
- asthma control questionnaire
- mini asthma quality of life questionnaire
- bronchial hyper-responsiveness questionnaire
- 8-item morisky medication adherence scale
- Timepointscross-sectional
- Trial web siten.a.
- statusplanned
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
- Publicationsn.a.
- 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: 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.
- Main changes (audit trail)
- RECORD8-okt-2015 - 4-feb-2016

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