NCT02345993|UnknownPhase 4
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Sponsor study identifier
interventional
120
1 country
1
Study Start
January 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2015
Date type not reportedThis date has not been verified as actual or estimated.
January 14, 2015
Actual (reported)January 26, 2015
Actual (reported)May 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Pulmonary Function
change in Forced Expiratory Volume in 1 second (FEV1) with respect to basal
120 minutes
Need for hospitalization
120 minutes
Change in perception of dyspnea
90 minutes
Biomarkers of inflammation
120 minutes
interleukins
120 min
Length of stay in hospital
1 week
adverse effects
1 week
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
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
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Extra fine Formoterol/Beclomethasone
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordNational Institute of Respiratory Diseases
Mexico City, Mexico City, 14080, Mexico
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.
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.
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.
Jose Luis Miguel, MD, MsC
Instituto Nacional de Enfermedades Respiratorias
First Submitted
January 14, 2015
First Posted
January 26, 2015
Study Start
January 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2015
Treatment Efficacy of Budesonide/Formoterol in Cough Variant Asthma and Typical Asthma Patients
Contact the study team to confirm eligibility.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 3, 2015
Record last verified: 2015-04
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Source: ClinicalTrials.gov.
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