AsthmaNCT00853411
Asthma Exacerbation Study
A study testing prednisone in people with Asthma, run by University of Pittsburgh.
Trial summary
Asthma is a clinical syndrome that is well recognized by health care practitioners, yet asthma pathogenesis still remains poorly understood. Asthma affects approximately 20 million Americans, who suffer around 5,000 deaths annually. More than 70% of people with asthma also suffer from allergies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- prednisone
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Feb 2011
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adults (age 18 and older) with moderate-severe persistent asthma identified by their physicians at the Comprehensive Lung Center and UPMC network physicians, and those individuals self-referred to the asthma research center will be considered for enrollment.
- All subjects will be involved in the research design first by participating in clinical testing to characterize the absence of any respiratory disease and the severity of asthma.
- Clinical testing will include:
- spirometry
- methacholine challenge (when necessary for diagnosis)
- allergy testing
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- nitric oxide monitoring.
- These tests will be performed as part of the research design on all adult subjects ages 18-60.
- Only patients on inhaled corticosteroids (CS) regularly at doses of >200 micrograms/day (fluticasone or equivalent) will be entered into the trial. There is no upper limit of CS dose.
Who cannot join
- The presence of any of the following will exclude a patient from study enrollment:
- Subjects with mental handicaps
- Subjects with obvious lower respiratory tract bacterial infection (pneumonia)
- Subjects who are unable to provide consent directly and for whom an appropriate legal representative cannot be found to provide consent
- Subjects who have previously indicated that they do not wish to be enrolled in this study.
- A greater than five pack year history of smoking or current smoking.
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- A prior diagnosis of vocal cord dysfunction, cystic fibrosis or chronic obstructive pulmonary disorder as well as any other lung disease besides asthma, or any coronary artery disease, hypertension, diabetes or renal failure that is not well-controlled as deemed by the principal investigator.
- Use of the 5 lipoxygenase inhibitor zileuton
- Regular use of aspirin or other nonsteroidal anti-inflammatory (intermittent use will be allowed, but patients will be asked to take acetaminophen while in the exacerbation phase of the trial if anti-pyretic/analgesic medication is required.
About this study
Official title: Th2 Effects on Eicosanoid Pathways: Implications for Altered Innate Responses in Asthma
Asthma is a clinical syndrome that is well recognized by health care practitioners, yet asthma pathogenesis still remains poorly understood. Asthma affects approximately 20 million Americans, who suffer around 5,000 deaths annually. More than 70% of people with asthma also suffer from allergies. Although many advances in understanding the pathophysiology of asthma have been made in the past few decades, more studies are necessary to achieve a more thorough understanding of asthma at the cellular and molecular level.
The majority of murine models suggest asthma and "allergic" responses involve activation of Th2 cytokine pathways, including IL-4 and -13. Similarly in humans, several lines of evidence support a large role for Th2 adaptive immunity. These include the large majority of asthmatic patients with atopy; the measurement of increased amounts of Th2 cytokines, including IL-4 and IL-13 in the airways and sputum of mild asthma; and most recently, the observed efficacy of anti-IgE therapy in "allergic" asthma. However, other data, including the large numbers of subjects with atopy and no asthma, suggest Th2 adaptive responses are insufficient to explain many aspects of asthma. Whether and how innate and adaptive immune pathways interact in human asthma is not clear, with few studies beginning to address these interactions in vitro and in vivo.
Read more
For this reason, the investigators of this study would like to prospectively enroll patients with known asthma and follow them through an asthma exacerbation, while treating them with a standardized protocol. Over six week's duration, the investigators would like to study patients by collecting physiologic data such as spirometry, and biologic material in the form of sputum, nasal scraping, venous blood, exhaled breath and sputum. It is our aim to fully characterize the impact of the prostaglandin/cycloygenase/eicosanoid pathway as it relates to asthma exacerbation and recovery.
Completion of this study in human asthma may provide new mechanistic insights into how relationships between innate and adaptive immune responses influence the course of an asthma exacerbation. The information obtained from this research and the corresponding studies may lead to innovative medical therapies and insight into the role of the epithelium and its interactions with both innate and adaptive immunity.
- Conditions
- Asthma
- Being tested
- prednisone
- Keywords
- Moderate to severe asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prednisoneDrug
Druing asthma exacerbation, subjects will be dosed to prednisone.
What is being measured
The primary outcome is the main question the study is designed to answer.
We will determine whether there is evidence for both adaptive and innate factors/responses in vivo at the time of an asthma exacerbation, as well as the relationship to infection.
Our primary outcome will be differences in 15S HETE, PGE2 and their ratio in sputum of asthmatics with worsening disease (exacerbations), as compared to their stable state (resolution).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2009 (estimated)
- Study startDec 2008
- Primary completionFeb 2011
- Study completionFeb 2011
Why it stopped: Terminated by Investigator due to lack of eligible subjects.
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 PittsburghThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sally E. Wenzel MD, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00853411
- Sponsor's protocol ID
- PRO08010052
- Status last verified
- Mar 2016
- First submitted
- 27 Feb 2009
- Last updated
- 22 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Th2 Effects on Eicosanoid Pathways: Implications for Altered Innate Responses in Asthma
- ClinicalTrials.gov ID
- NCT00853411
- Acronym / sponsor ID
- PRO08010052
- Conditions
- Asthma
- Keywords
- Moderate to severe asthma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Terminated by Investigator due to lack of eligible subjects.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 2 Mar 2009 (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.
Asthma is a clinical syndrome that is well recognized by health care practitioners, yet asthma pathogenesis still remains poorly understood. Asthma affects approximately 20 million Americans, who suffer around 5,000 deaths annually. More than 70% of people with asthma also suffer from allergies. Although many advances in understanding the pathophysiology of asthma have been made in the past few decades, more studies are necessary to achieve a more thorough understanding of asthma at the cellular and molecular level.
The majority of murine models suggest asthma and "allergic" responses involve activation of Th2 cytokine pathways, including IL-4 and -13. Similarly in humans, several lines of evidence support a large role for Th2 adaptive immunity. These include the large majority of asthmatic patients with atopy; the measurement of increased amounts of Th2 cytokines, including IL-4 and IL-13 in the airways and sputum of mild asthma; and most recently, the observed efficacy of anti-IgE therapy in "allergic" asthma. However, other data, including the large numbers of subjects with atopy and no asthma, suggest Th2 adaptive responses are insufficient to explain many aspects of asthma. Whether and how innate and adaptive immune pathways interact in human asthma is not clear, with few studies beginning to address these interactions in vitro and in vivo.
For this reason, the investigators of this study would like to prospectively enroll patients with known asthma and follow them through an asthma exacerbation, while treating them with a standardized protocol. Over six week's duration, the investigators would like to study patients by collecting physiologic data such as spirometry, and biologic material in the form of sputum, nasal scraping, venous blood, exhaled breath and sputum. It is our aim to fully characterize the impact of the prostaglandin/cycloygenase/eicosanoid pathway as it relates to asthma exacerbation and recovery.
Completion of this study in human asthma may provide new mechanistic insights into how relationships between innate and adaptive immune responses influence the course of an asthma exacerbation. The information obtained from this research and the corresponding studies may lead to innovative medical therapies and insight into the role of the epithelium and its interactions with both innate and adaptive immunity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- All adults (age 18 and older) with moderate-severe persistent asthma identified by their physicians at the Comprehensive Lung Center and UPMC network physicians, and those individuals self-referred to the asthma research center will be considered for enrollment.
- All subjects will be involved in the research design first by participating in clinical testing to characterize the absence of any respiratory disease and the severity of asthma.
- Clinical testing will include:
- These tests will be performed as part of the research design on all adult subjects ages 18-60.
- Only patients on inhaled corticosteroids (CS) regularly at doses of >200 micrograms/day (fluticasone or equivalent) will be entered into the trial. There is no upper limit of CS dose.
Key exclusion criteria (9 listed)
- The presence of any of the following will exclude a patient from study enrollment:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prednisoneDruing asthma exacerbation, subjects will be dosed to prednisone. | Drug | – |
Primary outcome
We will determine whether there is evidence for both adaptive and innate factors/responses in vivo at the time of an asthma exacerbation, as well as the relationship to infection.
Our primary outcome will be differences in 15S HETE, PGE2 and their ratio in sputum of asthmatics with worsening disease (exacerbations), as compared to their stable state (resolution).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing prednisone in people with Asthma, run by University of Pittsburgh.
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 9 inclusion and 9 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: withdrawn, as of the sponsor's last update on 22 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
We will determine whether there is evidence for both adaptive and innate factors/responses in vivo at the time of an asthma exacerbation, as well as the relationship to infection.. 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 22 Mar 2016.