The role of dynamic hyperinflation in asthma

Authors
Category Primary study
Registry of TrialsNetherlands Trial Register
Year 2016
INTERVENTION: One single i.m. injection of 2ml/80mg triamcinolone acetonide or matched placebo (2 ml NaCl 0.9%) in adult asthma patients with demostrated dynamic hyperinflation. CONDITION: Asthma, Adults, Dynamic hyperinflation ; ; PRIMARY OUTCOME: Part 1: The change in MPT‐induced dynamic hyperinflation before and 2 weeks after triamcinolone administration. We consider halving of dynamic hyperinflation as a clinical relevant result. SECONDARY OUTCOME: Part 1: The changes in questionnaire scores (ACQ, CCQ, SGRQ, BDI/TDI, LCADL, SOBDA, SNOT) and levels of FEV1 and exhaled NO before and 2 weeks after triamcinolone administration. Adverse events will be compared between the intervention group and placebo. Baseline characteristics will be used to identify potential predictors of response. ; ; ; ; Part 2: The association between level of MPT‐induced dynamic hyperinflation and severity and quality of specific respiratory symptoms as assessed in different respiratory questionnaires (SGRQ, CCQ, ACQ). ; ; The association between level of MPT‐induced dynamic hyperinflation and dyspnea during activities of daily life (BDI/TDI, LCADL, SOBDA) and nasal and ear symptoms (SNOT). ; ; ; ; Part 3: The association between level of MPT‐induced dynamic hyperinflation and level of blood eosinophils, healthcare utilisation and baseline characteristics. ; The relationship between quality and quantity of different symptoms/limitations and baseline characteristics and healthcare utilisation. ; ; ; ; Part 4: The agreement between CPET‐induced dynamic hyperinflation and MPT‐induced dynamic hyperinflation. ; ; ; ; Part 5: The difference between levels of MPT‐induced dynamic hyperinflation before and after bronchodilation. ; The association between level of pre‐ vs postbronchodilator MPT‐induced dynamic hyperinflation and symptoms, blood eosinophils and changes in MPT‐induced dynamic hyperinflation after triamcinolone. ; ; ; ; Part 6: The association between the level of specific immunophenotypic parameters and level of dynamic hyperinflation. ; ; The association between the level of specific immunophenotypic parameters and ; ; ‐ Clinical characteristics (i.a. atopy, age‐at‐onset asthma, smoking history) ; ; ‐ Quality and quantity of symptoms ; ; ‐ Healthcare utilisation ; ; ‐ Lung function measurements (FEV1, VC, reversibility) ; ; ‐ FeNO ; ; ‐ Peripheral blood eosinophils ; ; 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% of predicted ‐ MPT induced dynamic hyperinflation: IC >‐10% ‐ CPET induced dynamic hyperinflation: IC >‐10%
Epistemonikos ID: 1bd92d0bd7fc3410d6c2759295767e2a29ae3b74
First added on: Aug 24, 2024