Extra-fine Formoterol/Beclomethasone in Asthmatic Crisis

• Register: ClinicalTrials.gov
• Last refreshed on: 13 April 2015
• Main ID: NCT02345993
• Date of registration: 14/01/2015
• Prospective Registration: No
• Primary sponsor: National Institute of Respiratory Diseases, Mexico
• Public title: Extra-fine Formoterol/Beclomethasone in Asthmatic Crisis
• Scientific title: Extra-fine Formoterol/Beclomethasone in the Treatment of Asthmatic Crisis
• Date of first enrolment: January 2015
• Target sample size: 120
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT02345993
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Mexico

Contacts

• Name: Jose Luis Miguel, MD, MsC
• Affiliation: National Institute of Respiratory Diseases

Key inclusion & exclusion criteria

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%.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Asthma

Asthmatic Crisis

Intervention(s)

Drug: Extra fine Formoterol/Beclomethasone

Primary Outcome(s)

Pulmonary Function [Time Frame: 120 minutes]

Secondary Outcome(s)

Need for hospitalization [Time Frame: 120 minutes]

Biomarkers of inflammation [Time Frame: 120 minutes]

interleukins [Time Frame: 120 min]

Change in perception of dyspnea [Time Frame: 90 minutes]

Secondary ID(s)

C40-14

Source(s) of Monetary Support

Please refer to primary and secondary sponsors