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Small Airway function in obesity and asthma study

Small Airway function in obesity and asthma study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON23609
Enrollment
80
Registered
2015-10-08
Start date
2016-01-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

asthma, obesity

Interventions

no intervention

Sponsors

Leiden University Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Age &#8805; 18 who have signed informed consent form prior to the start of the study • Clinical diagnosis for &#8805; 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 &#8805;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 &#8805; 10 cigarettes per day or &#8805;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

Secondary

MeasureTime frame
- 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

Primary

MeasureTime frame
impulse oscillometry

Contacts

Public ContactT.N. Bonten
t.n.bonten@lumc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)