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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extra fine Formoterol/Beclomethasone | Active Comparator | 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 |
|
| Placebo | Placebo Comparator | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extra fine Formoterol/Beclomethasone | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary Function | change in Forced Expiratory Volume in 1 second (FEV1) with respect to basal | 120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Need for hospitalization | 120 minutes | |
| Change in perception of dyspnea | change in Borg and Transitional Dyspnea Index | 90 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay in hospital | in patients requiring hospitalisation, evaluate length of stay | 1 week |
| adverse effects | adverse effects related to the drug |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose Luis Miguel, MD, MsC | Instituto Nacional de Enfermedades Respiratorias | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Respiratory Diseases | Mexico City | Mexico City | 14080 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24041942 | Background | Martinez FD, Vercelli D. Asthma. Lancet. 2013 Oct 19;382(9901):1360-72. doi: 10.1016/S0140-6736(13)61536-6. Epub 2013 Sep 13. | |
| 22832835 | Background | Garcia-Sancho C, Fernandez-Plata R, Martinez-Briseno D, Franco-Marina F, Perez-Padilla JR. [Adult asthma in Mexico City: a population-based study]. Salud Publica Mex. 2012 Jul-Aug;54(4):425-32. doi: 10.1590/s0036-36342012000400013. Spanish. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D013224 | Status Asthmaticus |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D001507 | Beclomethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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|
|
| 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 |
| 1 week |
| 15006973 | Background | Rodrigo GJ, Rodrigo C, Hall JB. Acute asthma in adults: a review. Chest. 2004 Mar;125(3):1081-102. doi: 10.1378/chest.125.3.1081. |
| 24899370 | Background | Lipworth B, Manoharan A, Anderson W. Unlocking the quiet zone: the small airway asthma phenotype. Lancet Respir Med. 2014 Jun;2(6):497-506. doi: 10.1016/S2213-2600(14)70103-1. |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013258 | Steroids, Chlorinated |