The role of dynamic hyperinflation in asthma

Phase 4

Completed

Conditions: bronchitis
10024967
asthma

Registration Number: NL-OMON43421

Lead Sponsor: Medisch Centrum Leeuwarden

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

Adults with symptoms compatible with asthma or COPD
Non-smoking, *10 packyears
BMI *30
ICS (*500 mcg fluticasone equivalent) or daily oral corticosteroids combined with LABA or other controller for at least 6 months.
Stable disease, no exacerbations in last 4 weeks
FEV1/FVC *80% predicted pre-bronchodilation
MPT induced dynamic hyperinflation: * IC *-10%
CPET induced dynamic hyperinflation: * IC *-10%

Exclusion Criteria

Concurrent respiratory diseases
Clinically significant cardiovascular disease
Pregnant or breastfeeding women
History of hypertension, diabetes mellitus, menorrhagia, immunodeficiency, psychiatric diseases, idiopathic thrombocytopenic purpura, ulcus ventriculi, ulcus duodeni, infectious disease and infection after administration of live or live, attenuated vaccines.
Hypersensitivity to any components of triamcinolon acetonide,

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameter:<br /><br>Part 1: The change in MPT-induced dynamic hyperinflation before and 2 weeks<br /><br>after triamcinolone administration. We consider halving of dynamic<br /><br>hyperinflation as a clinical relevant result.<br /><br>Part 2: The association between level of MPT-induced dynamic hyperinflation and<br /><br>severity and quality of specific respiratory symptoms as assessed in different<br /><br>respiratory questionnaires (SGRQ, CCQ, ACQ, BDI/TDI, LCADL, SOBDA).<br /><br>Part 3: The association between level of MPT-induced dynamic hyperinflation and<br /><br>level of blood eosinophils.<br /><br>Part 4: The agreement between CPET-induced dynamic hyperinflation and<br /><br>MPT-induced dynamic hyperinflation.<br /><br>Part 5: The difference between levels of MPT-induced dynamic hyperinflation<br /><br>before and after bronchodilation.<br /><br>Part 6: The association between the level of specific immunophenotypic<br /><br>parameters and level of dynamic hyperinflation. </p><br>

Secondary Outcome Measures