Asthma, adults, dynamic hyperinflation, small airway inflammation
Conditions
Interventions
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.
Sponsors
Medical Centre Leeuwarden
Eligibility
Inclusion criteria
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%
Exclusion criteria
Exclusion criteria: - Concurrent respiratory diseases - Clinically significant cardiovascular disease - Pregnant or breastfeeding women - History of hypertension, diabetes mellitus, menorrhagia, psychiatric diseases, idiopathic thrombocytopenic purpura, ulcus ventriculi, ulcus duodeni, infectious disease, infection after administration of live or live, attenuated vaccines. - Hypersensitivity to any components of triamcinolon acetonide.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactA. ten Brinke
Medical Centre Leeuwarden
Outcome results
None listed