Extra-fine Formoterol/Beclomethasone in Asthmatic Crisis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Asthma Asthmatic Crisis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Extra fine Formoterol/Beclomethasone

Intervention Type 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

Placebo

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

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Extra fine Formoterol/Beclomethasone

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

Intervention Type DRUG

Other Intervention Names

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Innovair

Eligibility Criteria

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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%.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes