Asthma
Conditions
Interventions
Trade Name: Kenacort-A 40
Product Name: Triamcinolone acetonide
Product Code: 05341
Pharmaceutical Form: Injection
Pharmaceutical form of the placebo: Injection
Route of administration of the placebo:
Sponsors
Stichting Longgeneeskunde Fryslan
Eligibility
Sex/Gender
All
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% Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
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 |
|---|---|
| Main Objective: The aim of this study is to investigate the effect of supplementation of a single intramuscular dose of 80 mg triamcinolone on the level of MPT-induced dynamic hyperinflation, in adult asthma patients with demonstrated dynamic hyperinflation (Part 1);Secondary Objective: Part 2: To investigate the relationship between MPT-induced dynamic hyperinflation and respiratory symptoms and limitations in daily activities as assessed in different questionnaires Part 3: To investigate the relationship between MPT-induced dynamic hyperinflation and eosinophilic inflammation in peripheral blood. Part 4: To evaluate the agreement between level of dynamic hyperinflation induced by MPT versus CPET. Part 5: To evaluate the difference between levels of MPT-induced dynamic hyperinflation pre vs post bronchodilation in relationship to symptoms, blood eosinophils and triamcinolone-induced changes in dynamic hyperinflation Part 6: To investigate whether specific immunophenotypic characteristics (i.a. expression/activity of type 2 innate lymphoid cells (ILC2)) are associated with (small) airway inflammation and dynamic hyperinflation. ;Primary end point(s): Part 1: The change in MPT-induced dynamic hyperinflation before and 2 weeks after triamcinolone administration.;Timepoint(s) of evaluation of this end point: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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). 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 (i.a. type 2 innate lymphoid cells) and level of dynamic hyperinflation. ;Timepoint(s) of evaluation of this end point: 4 weeks | — |
Countries
Netherlands
Contacts
Public ContactA. ten Brinke
Medical Centre Leeuwarden
Outcome results
None listed