Extra-fine Formoterol/Beclomethasone in Asthmatic Crisis

April 1, 2015 updated by: Jose Luis Miguel, National Institute of Respiratory Diseases, Mexico

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 14080
        • National Institute of Respiratory Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
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

Other Names:
  • Innovair
Placebo Comparator: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary Function
Time Frame: 120 minutes
change in Forced Expiratory Volume in 1 second (FEV1) with respect to basal
120 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for hospitalization
Time Frame: 120 minutes
120 minutes
Change in perception of dyspnea
Time Frame: 90 minutes
change in Borg and Transitional Dyspnea Index
90 minutes
Biomarkers of inflammation
Time Frame: 120 minutes
change in C- reactive protein, TNF-alpha, eosinophils
120 minutes
interleukins
Time Frame: 120 min
change in eosinophilic and non eosinophilic interleukins (IL-4, IL-5, IL-13, IL-17, IL-33)
120 min

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay in hospital
Time Frame: 1 week
in patients requiring hospitalisation, evaluate length of stay
1 week
adverse effects
Time Frame: 1 week
adverse effects related to the drug
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Respiratory Diseases, Mexico

Investigators

  • Principal Investigator: Jose Luis Miguel, MD, MsC, National Institute of Respiratory Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

May 1, 2015

Study Completion (Anticipated)

August 1, 2015

Study Registration Dates

First Submitted

January 14, 2015

First Submitted That Met QC Criteria

January 19, 2015

First Posted (Estimate)

January 26, 2015

Study Record Updates

Last Update Posted (Estimate)

April 3, 2015

Last Update Submitted That Met QC Criteria

April 1, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C40-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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