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Extra-fine Formoterol/Beclomethasone in Asthmatic Crisis

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ClinicalTrials.gov Identifier: NCT02345993
Recruitment Status : Unknown
Verified April 2015 by Jose Luis Miguel, National Institute of Respiratory Diseases, Mexico.
Recruitment status was:  Active, not recruiting
First Posted : January 26, 2015
Last Update Posted : April 3, 2015
Sponsor:
Information provided by (Responsible Party):
Jose Luis Miguel, National Institute of Respiratory Diseases, Mexico

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.

Condition or disease Intervention/treatment Phase
Asthma Asthmatic Crisis Drug: Extra fine Formoterol/Beclomethasone Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Extra-fine Formoterol/Beclomethasone in the Treatment of Asthmatic Crisis
Study Start Date : January 2015
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : August 2015


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 Name: 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




Primary Outcome Measures :
  1. Pulmonary Function [ Time Frame: 120 minutes ]
    change in Forced Expiratory Volume in 1 second (FEV1) with respect to basal


Secondary Outcome Measures :
  1. Need for hospitalization [ Time Frame: 120 minutes ]
  2. Change in perception of dyspnea [ Time Frame: 90 minutes ]
    change in Borg and Transitional Dyspnea Index

  3. Biomarkers of inflammation [ Time Frame: 120 minutes ]
    change in C- reactive protein, TNF-alpha, eosinophils

  4. interleukins [ Time Frame: 120 min ]
    change in eosinophilic and non eosinophilic interleukins (IL-4, IL-5, IL-13, IL-17, IL-33)


Other Outcome Measures:
  1. Length of stay in hospital [ Time Frame: 1 week ]
    in patients requiring hospitalisation, evaluate length of stay

  2. adverse effects [ Time Frame: 1 week ]
    adverse effects related to the drug



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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%.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02345993


Locations
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Mexico
National Institute of Respiratory Diseases
Mexico, Distrito Federal, Mexico, 14080
Sponsors and Collaborators
National Institute of Respiratory Diseases, Mexico
Investigators
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Principal Investigator: Jose Luis Miguel, MD, MsC National Institute of Respiratory Diseases

Publications:
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Responsible Party: Jose Luis Miguel, MD, MsC, National Institute of Respiratory Diseases, Mexico
ClinicalTrials.gov Identifier: NCT02345993     History of Changes
Other Study ID Numbers: C40-14
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: April 2015
Keywords provided by Jose Luis Miguel, National Institute of Respiratory Diseases, Mexico:
formoterol/beclomethasone in asthmatic crisis
asthmatic crisis treatment
Additional relevant MeSH terms:
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Asthma
Status Asthmaticus
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Methylprednisolone
Beclomethasone
Albuterol
Formoterol Fumarate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists