Extra-fine Formoterol/Beclomethasone in Asthmatic Crisis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Condition or disease||Intervention/treatment||Phase|
|Asthma Asthmatic Crisis||Drug: Extra fine Formoterol/Beclomethasone||Phase 4|
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 (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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
- Pulmonary Function [ Time Frame: 120 minutes ]change in Forced Expiratory Volume in 1 second (FEV1) with respect to basal
- Need for hospitalization [ Time Frame: 120 minutes ]
- Change in perception of dyspnea [ Time Frame: 90 minutes ]change in Borg and Transitional Dyspnea Index
- Biomarkers of inflammation [ Time Frame: 120 minutes ]change in C- reactive protein, TNF-alpha, eosinophils
- interleukins [ Time Frame: 120 min ]change in eosinophilic and non eosinophilic interleukins (IL-4, IL-5, IL-13, IL-17, IL-33)
- Length of stay in hospital [ Time Frame: 1 week ]in patients requiring hospitalisation, evaluate length of stay
- adverse effects [ Time Frame: 1 week ]adverse effects related to the drug
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
|National Institute of Respiratory Diseases|
|Mexico, Distrito Federal, Mexico, 14080|
|Principal Investigator:||Jose Luis Miguel, MD, MsC||National Institute of Respiratory Diseases|