Extra-fine Formoterol/Beclomethasone in Asthmatic Crisis

Asthma Clinical Trial

Official title:

Extra-fine Formoterol/Beclomethasone in the Treatment of Asthmatic Crisis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02345993
• Other study ID #: C40-14
• Status: Active, not recruiting
• Phase: Phase 4
• First received: January 14, 2015
• Last updated: April 1, 2015
• Start date: January 2015
• Est. completion date: August 2015

Study information

• Verified date: April 2015
• Source: National Institute of Respiratory Diseases, Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Protection Against Health Risks
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: August 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Asthmatic Crisis
• Status Asthmaticus

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Mexico	National Institute of Respiratory Diseases	Mexico	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Respiratory Diseases, Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (4)

García-Sancho C, Fernández-Plata R, Martínez-Briseño D, Franco-Marina F, Pérez-Padilla JR. [Adult asthma in Mexico City: a population-based study]. Salud Publica Mex. 2012 Jul-Aug;54(4):425-32. Spanish. — View Citation

Lipworth B, Manoharan A, Anderson W. Unlocking the quiet zone: the small airway asthma phenotype. Lancet Respir Med. 2014 Jun;2(6):497-506. doi: 10.1016/S2213-2600(14)70103-1. Review. — View Citation

Martinez FD, Vercelli D. Asthma. Lancet. 2013 Oct 19;382(9901):1360-72. doi: 10.1016/S0140-6736(13)61536-6. Epub 2013 Sep 13. Review. — View Citation

Rodrigo GJ, Rodrigo C, Hall JB. Acute asthma in adults: a review. Chest. 2004 Mar;125(3):1081-102. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of stay in hospital	in patients requiring hospitalisation, evaluate length of stay	1 week	No
Other	adverse effects	adverse effects related to the drug	1 week	Yes
Primary	Pulmonary Function	change in Forced Expiratory Volume in 1 second (FEV1) with respect to basal	120 minutes	No
Secondary	Need for hospitalization		120 minutes	No
Secondary	Change in perception of dyspnea	change in Borg and Transitional Dyspnea Index	90 minutes	No
Secondary	Biomarkers of inflammation	change in C- reactive protein, TNF-alpha, eosinophils	120 minutes	No
Secondary	interleukins	change in eosinophilic and non eosinophilic interleukins (IL-4, IL-5, IL-13, IL-17, IL-33)	120 min	No