Overview

This trial is active, not recruiting.

Conditions asthma, asthmatic crisis
Treatment extra fine formoterol/beclomethasone
Phase phase 4
Sponsor National Institute of Respiratory Diseases, Mexico
Start date January 2015
End date May 2015
Trial size 120 participants
Trial identifier NCT02345993, C40-14

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(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
extra fine formoterol/beclomethasone Innovair
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
(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

Primary Outcomes

Measure
Pulmonary Function
time frame: 120 minutes

Secondary Outcomes

Measure
Need for hospitalization
time frame: 120 minutes
Change in perception of dyspnea
time frame: 90 minutes
Biomarkers of inflammation
time frame: 120 minutes
interleukins
time frame: 120 min

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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%.

Additional Information

Official title Extra-fine Formoterol/Beclomethasone in the Treatment of Asthmatic Crisis
Principal investigator Jose Luis Miguel, MD, MsC
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by National Institute of Respiratory Diseases, Mexico.