ASTHMAacute asthmaNCT01690793
Measurement of Natriuretic Hormone Peptides in Exacerbation of Asthma
An observational study of ASTHMA, run by University of South Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- ASTHMA
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Feb 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The Asthma Control Test score of less than 18. Asthma control test consists of five questions, scored 1-5 each.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Usf Asthma Allergy and Immunology Cru
Tampa, Florida, 33613
About this study
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.
Read the 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.
- Conditions
- ASTHMA
- Keywords
- ASTHMA, ACUTE EXACERBATION OF ASTHMA
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
The measurement of NHPs after treatment of an exacerbation of asthma
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2012 (estimated)
- Study startFeb 2009
- Primary completionDec 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ASTHMAStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Lockey, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690793
- Sponsor's protocol ID
- acute asthma
- Acronym
- acute asthma
- Status last verified
- May 2015
- First submitted
- 5 Aug 2010
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Natriuretic Hormone Peptides in Exacerbation of Asthma
- ClinicalTrials.gov ID
- NCT01690793
- Acronym / sponsor ID
- acute asthma / acute asthma
- Conditions
- ASTHMA
- Keywords
- ASTHMA, ACUTE EXACERBATION OF ASTHMA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 24 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The Asthma Control Test score of less than 18. Asthma control test consists of five questions, scored 1-5 each.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The measurement of NHPs after treatment of an exacerbation of asthma
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ASTHMA, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The measurement of NHPs after treatment of an exacerbation of asthma (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.