Clinical trial NCT02345993: Extra-fine Formoterol/Beclomethasone in Asthmatic Crisis
Official title: Extra-fine Formoterol/Beclomethasone in the Treatment of Asthmatic Crisis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Asthma
Asthmatic Crisis
Keywords: formoterol/beclomethasone in asthmatic crisis
asthmatic crisis treatment
Lead sponsor: National Institute of Respiratory Diseases, Mexico
Sponsor class: OTHER_GOV
First posted: 2015-01-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

Eligibility criteria: 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%.

Primary outcomes:
measure: Pulmonary Function
timeFrame: 120 minutes
Secondary outcomes:
measure: Need for hospitalization
timeFrame: 120 minutes
measure: Change in perception of dyspnea
timeFrame: 90 minutes
measure: Biomarkers of inflammation
timeFrame: 120 minutes
measure: interleukins
timeFrame: 120 min
Other outcomes:
measure: Length of stay in hospital
timeFrame: 1 week
measure: adverse effects
timeFrame: 1 week
Locations:
city: Mexico
country: Mexico
facility: National Institute of Respiratory Diseases
state: Distrito Federal
Study officials:
affiliation: National Institute of Respiratory Diseases
name: Jose Luis Miguel, MD, MsC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.