NCT02345993

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_4 asthma

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_4 asthma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

April 3, 2015

Status Verified

April 1, 2015

Enrollment Period

4 months

First QC Date

January 14, 2015

Last Update Submit

April 1, 2015

Conditions

AsthmaAsthmatic Crisis

Keywords

formoterol/beclomethasone in asthmatic crisisasthmatic crisis treatment

Outcome Measures

Primary Outcomes (1)

  • Pulmonary Function

    change in Forced Expiratory Volume in 1 second (FEV1) with respect to basal

    120 minutes

Secondary Outcomes (4)

  • Need for hospitalization

    120 minutes

  • Change in perception of dyspnea

    90 minutes

  • Biomarkers of inflammation

    120 minutes

  • interleukins

    120 min

Other Outcomes (2)

  • Length of stay in hospital

    1 week

  • adverse effects

    1 week

Study Arms (2)

Extra fine Formoterol/Beclomethasone

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

Drug: Extra fine Formoterol/Beclomethasone

Placebo

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

Interventions

Extra fine Formoterol/BeclomethasoneDRUG

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

Also known as: Innovair
Extra fine Formoterol/Beclomethasone

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • previous asthma diagnosis by physician
  • spirometry with quality grade A, B or C
  • presenting with asthmatic crisis in emergency room

You may not qualify if:

  • 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%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Respiratory Diseases

Mexico City, Mexico City, 14080, Mexico

Location

Related Publications (4)

  • 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.

    PMID: 24041942BACKGROUND

  • Garcia-Sancho C, Fernandez-Plata R, Martinez-Briseno D, Franco-Marina F, Perez-Padilla JR. [Adult asthma in Mexico City: a population-based study]. Salud Publica Mex. 2012 Jul-Aug;54(4):425-32. doi: 10.1590/s0036-36342012000400013. Spanish.

    PMID: 22832835BACKGROUND

  • Rodrigo GJ, Rodrigo C, Hall JB. Acute asthma in adults: a review. Chest. 2004 Mar;125(3):1081-102. doi: 10.1378/chest.125.3.1081.

    PMID: 15006973BACKGROUND

  • 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.

    PMID: 24899370BACKGROUND

MeSH Terms

Conditions

AsthmaStatus Asthmaticus

Interventions

Beclomethasone

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Chlorinated

Study Officials

  • Jose Luis Miguel, MD, MsC

    Instituto Nacional de Enfermedades Respiratorias

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MsC

Study Record Dates

First Submitted

January 14, 2015

First Posted

January 26, 2015

Study Start

January 1, 2015

Primary Completion

May 1, 2015

Study Completion

August 1, 2015

Last Updated

April 3, 2015

Record last verified: 2015-04

Locations

ME(1)