Extra-fine Formoterol/Beclomethasone in Asthmatic Crisis

National Institute of Respiratory Diseases, Mexico

Status and phase: Unknown; Phase 4

Conditions: Asthma; Asthmatic Crisis

Treatments: Drug: Extra fine Formoterol/Beclomethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT02345993

C40-14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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%.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

120 participants in 2 patient groups, including a placebo group

Extra fine Formoterol/Beclomethasone

Active Comparator group

Description:

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

Treatment:

Drug: Extra fine Formoterol/Beclomethasone

Placebo

Placebo Comparator group

Description:

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