asthma bronchitis
Conditions
Interventions
One group receives a single dose of triamcinolone acetonide injection (80mg)
intramuscular. The other group receives a placebo.
Sponsors
Medisch Centrum Leeuwarden
Eligibility
Age
18 Years to 99 Years
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% predicted pre-bronchodilation 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, 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,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameter: 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. 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, BDI/TDI, LCADL, SOBDA). Part 3: The association between level of MPT-induced dynamic hyperinflation and level of blood eosinophils. 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. Part 6: The association between the level of specific immunophenotypic parameters and level of dynamic hyperinflation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters: 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 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 health care utilisation (HCU) and baseline characteristics. The relationship between quality and quantity of different symptoms/limitations and baseline characteristics and health care utilisation. Part 5: 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 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 | — |
Countries
Netherlands
Outcome results
None listed