Asthma, Asthmatic Crisis
Conditions
Keywords
formoterol/beclomethasone in asthmatic crisis, asthmatic crisis treatment
Brief summary
The purpose of this study is to determine whether extra fine formoterol/beclomethasona are more effective in the treatment of asthmatic crisis when added to conventional treatment compared with conventional treatment alone.
Detailed description
Inhaled corticosteroids still the cornerstone in treatment of stable asthma, while bronchodilators and systemic steroids are in asthmatic crisis. Asthmatic exacerbations are events occurring in the natural course of the disease, require a change in actual medication and they are associated with risks of complications producing important economic costs. Some is known about non-genomic effects of inhaled corticosteroids, making possible, at least in theory, having a positive effect on treatment of a crisis. On the other hand, formoterol has been shown to have a rapid beginning of action (3 minutes), persisting its effect during 12 hours and it has been shown to be as effective as albuterol in the treatment of a crisis. The development of extra-fine particles has allowed reaching more distal zones in the lungs producing more deposition of the drug, which as well decrease adverse effects are lesser doses of the drug are needed. According to that, aims of this work is to determine whether extra-fine formoterol/beclomethasona are more effective in the treatment of asthmatic crisis when added to conventional treatment compared with conventional treatment in terms of pulmonary function, symptoms, inflammation markers and rates of hospitalization.
Interventions
DRUGExtra fine Formoterol/Beclomethasone
standard treatment consisting in: Albuterol 2.5 mg via nebulizer at baseline (0), 20, 40 minutes + Systemic steroid (methylprednisolone 60 mg) at the moment of evaluation \+ formoterol/beclomethasone, 3 puffs administered via aerochamber at baseline (0), 20, 40, 60 minutes
Sponsors
National Institute of Respiratory Diseases, Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* previous asthma diagnosis by physician * spirometry with quality grade A, B or C * presenting with asthmatic crisis in emergency room
Exclusion criteria
* imminent respiratory arrest * respiratory comorbidities (COPD, cystic fibrosis, interstitial lung disease, pneumothorax, bronchiectasis) * use of systemic steroids in 3 months previous * allergy to steroids * Peripheral capillary oxygen saturation (SpO2) less than 88%.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary Function | 120 minutes | change in Forced Expiratory Volume in 1 second (FEV1) with respect to basal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for hospitalization | 120 minutes | — |
| Change in perception of dyspnea | 90 minutes | change in Borg and Transitional Dyspnea Index |
| Biomarkers of inflammation | 120 minutes | change in C- reactive protein, TNF-alpha, eosinophils |
| interleukins | 120 min | change in eosinophilic and non eosinophilic interleukins (IL-4, IL-5, IL-13, IL-17, IL-33) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Length of stay in hospital | 1 week | in patients requiring hospitalisation, evaluate length of stay |
| adverse effects | 1 week | adverse effects related to the drug |
Countries
Mexico
Outcome results
None listed