NCT01690793

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

September 24, 2012

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

1.8 years

First QC Date

August 5, 2010

Last Update Submit

May 27, 2015

Conditions

ASTHMA

Keywords

ASTHMAACUTE EXACERBATION OF ASTHMA

Outcome Measures

Primary Outcomes (1)

  • The measurement of NHPs after treatment of an exacerbation of asthma

    14 days

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The Asthma Control Test score of less than 18. Asthma control test consists of five questions, scored 1-5 each.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Usf Asthma Allergy and Immunology Cru

Tampa, Florida, 33613, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prinicpal investigator

Study Record Dates

First Submitted

August 5, 2010

First Posted

September 24, 2012

Study Start

February 1, 2009

Primary Completion

December 1, 2010

Study Completion

February 1, 2011

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

US(1)