Extra-fine Formoterol/Beclomethasone in Asthmatic Crisis

Phase 4

• Conditions: Asthma; Asthmatic Crisis
• Interventions: Drug: Extra fine Formoterol/Beclomethasone

• Registration Number: NCT02345993
• Lead Sponsor: National Institute of Respiratory Diseases, Mexico

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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-14
• Study First Submitted QC: 2015-01-19
• Study First Posted: 2015-01-26
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-01
• Last Update Posted: 2015-04-03
• Primary Completion: 2015-05
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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%.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extra fine Formoterol/Beclomethasone	Extra fine Formoterol/Beclomethasone	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

Primary Outcome Measures

Name	Time	Method
Pulmonary Function	120 minutes	change in Forced Expiratory Volume in 1 second (FEV1) with respect to basal

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Institute of Respiratory Diseases; 🇲🇽 Mexico, Distrito Federal, Mexico