Extra-fine Formoterol/Beclomethasone in the Treatment of Asthmatic Crisis
Trial Snapshot
- Phase
- Phase 4
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Pulmonary Function
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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%.
Arms & Interventions
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
Intervention: Extra fine Formoterol/Beclomethasone (Drug)
Outcomes
Primary Outcomes
Pulmonary Function
Time Frame: 120 minutes
change in Forced Expiratory Volume in 1 second (FEV1) with respect to basal
Secondary Outcomes
- Need for hospitalization(120 minutes)
- Change in perception of dyspnea(90 minutes)
- interleukins(120 min)
- Biomarkers of inflammation(120 minutes)
Investigators
Jose Luis Miguel
MD, MsC
National Institute of Respiratory Diseases, Mexico