Extra-fine Formoterol/Beclomethasone in Asthmatic Crisis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Extra-fine Formoterol/Beclomethasone in the Treatment of Asthmatic Crisis

Conditions
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Asthma, Asthmatic Crisis

Intervention / Treatment
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* Drug: Extra fine Formoterol/Beclomethasone


Participation Criteria
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Eligibility Criteria
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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%.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Extra fine Formoterol/Beclomethasone<br>Group receiving the drug additional to standard treatment 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 minutes | Drug: Extra fine Formoterol/Beclomethasone<br>* 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<br>* Other names: Innovair;|
| Placebo Comparator: Placebo<br>Group receiving placebo additional to 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 + Placebo, 3 puffs administered via aerochamber at baseline (0), 20, 40 minutes | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary Function | change in Forced Expiratory Volume in 1 second (FEV1) with respect to basal | 120 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for hospitalization |  | 120 minutes | 
| Change in perception of dyspnea | change in Borg and Transitional Dyspnea Index | 90 minutes | 
| Biomarkers of inflammation | change in C- reactive protein, TNF-alpha, eosinophils | 120 minutes | 
| interleukins | change in eosinophilic and non eosinophilic interleukins (IL-4, IL-5, IL-13, IL-17, IL-33) | 120 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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formoterol/beclomethasone in asthmatic crisis, asthmatic crisis treatment