Measurement of Natriuretic Hormone Peptides in Exacerbation of Asthma (acute asthma)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Richard Lockey, University of South Florida

ClinicalTrials.gov Identifier:

NCT01690793

First received: August 5, 2010

Last updated: September 18, 2012

Last verified: September 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	August 5, 2010
Last Updated Date	September 18, 2012
Start Date ^ICMJE	February 2009
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 18, 2012)	The measurement of NHPs after treatment of an exacerbation of asthma [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01690793 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Measurement of Natriuretic Hormone Peptides in Exacerbation of Asthma
Official Title ^ICMJE	Measurement of Natriuretic Hormone Peptides in Exacerbation of Asthma
Brief Summary	The investigators hypothesize that there is a statistically significant decrease of Natriuretic Hormone Peptides (NHPs) in subjects with asthma exacerbation compared to levels following treatment of an exacerbation of asthma.
Detailed Description	Overall Study Design Measurement of Natriuretic Hormone Peptides in individuals suffering from exacerbation of asthma. Measurement of Natriuretic Hormone Peptides 5-7 days after initiation of treatment of exacerbation of asthma. Measurement of Natriuretic Hormone Peptides 10-14 days after initiation of treatment of exacerbation of asthma. 3 comparisons of Natriuretic Hormone Peptides levels will be made: Exacerbation compared to 5-7 days after initiation of treatment Exacerbation compared to 10-14 days after initiation of treatment 5-7 days after initiation of treatment compared to 10-14 days after initiation of treatment. Samples of blood will be secured in the Division of Allergy/Immunology at the University of South Florida, Joy McCann Culverhouse Airways Disease Center. All samples will be appropriately coded to maintain confidentiality. Blood specimens will be held at minus 20 degrees Celsius.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Not Provided
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA Description: Samples of blood will be secured in the Division of Allergy/Immunology at the University of South Florida, Joy McCann Culverhouse Airways Disease Center. All samples will be appropriately coded to maintain confidentiality. Blood specimens will be held at minus 20 degrees Celsius. GENETICS SAMPLES ARE OPTIONAL
Sampling Method	Probability Sample
Study Population	The Asthma Control Test score of less than 18. Asthma control test consists of five questions, scored 1-5 each.
Condition ^ICMJE	ASTHMA
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	30
Completion Date	February 2011
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Both genders, age 18-85. Females who are pregnant or lactating are not eligible. Read and comprehend English. Ability to give informed consent. Seen in the outpatient setting at one of the clinic. The subject must have a history of physician diagnosed asthma for at least 1 year and must have an exacerbation of asthma for entry into the study.
Gender	Both
Ages	18 Years to 85 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01690793
Other Study ID Numbers ^ICMJE	acute asthma
Has Data Monitoring Committee	No
Responsible Party	Richard Lockey, University of South Florida
Study Sponsor ^ICMJE	University of South Florida
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of South Florida
Verification Date	September 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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