AsthmaNCT00620334
Predicting the Diagnosis of Asthma
An observational study of Asthma, run by University of South Florida at 1 site in United States.
Trial summary
Despite the development of effective medications for treatment, asthma remains a significant contributor of morbidity, mortality, and financial hardship to patients with the disease. An estimated 300 million people worldwide have asthma, making it one of the most common chronic diseases in the world. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Jun 2008
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Male or female Females are eligible to participate only if they are currently non-pregnant and non-lactating. All premenopausal women will undergo a urine pregnancy test at the beginning of the study. Female subjects should not be enrolled if they plan to become pregnant during the time of the study.
Who may be able to join
- 18-64 years of age at enrollment
- Literacy: The subject must be able to read, comprehend, and record information in English.
- Consent: The subject must have the ability to give informed consent.
- Type of subject: The subject must be seen in the outpatient setting.
Who cannot join
- Respiratory Instability: Hospitalization for respiratory disease within the last 6 months during study period and prior to Visit 0.
- Respiratory Disease: Current diagnosis of cystic fibrosis, pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, chronic bronchitis, or any other lower respiratory abnormalities other than asthma.
- Prior Treatment of Asthma: Treatment for asthma with any medication (except for short acting inhaled bronchodilators) for 12 months or more prior to Visit 0
- Drug Allergy: Any immediate or delayed hypersensitivity reaction to any beta2-agonist or sympathomimetic drug
- Respiratory Tract Infections: Confirmed or suspected infection of the sinus, middle ear, oropharynx, upper respiratory tract, or lower respiratory tract within 28 days prior to testing
- Other Concurrent Conditions/Diseases: Any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the results if the condition/disease exacerbates during the study. The list of conditions/diseases that will result in exclusion if determined to be clinically significant includes, but is not limited to: cardiac arrhythmia, congestive heart failure, coronary artery disease, Addison's disease, diabetes mellitus, dyspnea by any cause other than asthma, uncontrolled hypertension, hematological, hepatic, neurological, thyroid, peptic ulcer, or renal disease, immunologic compromise, current malignancy, current or quiescent tuberculosis.
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- Concomitant Medications:
- Beta blockers
- Systemic corticosteroids
- Angiotensin Converting Enzyme (ACE) inhibitors (Note: Immunotherapy for the treatment of allergies is allowed, provided that the subject has received a constant dose for 30 days prior to Visit 0, and that the same dose will continue throughout the study.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predicting the Diagnosis of Asthma Based on History
Despite the development of effective medications for treatment, asthma remains a significant contributor of morbidity, mortality, and financial hardship to patients with the disease. An estimated 300 million people worldwide have asthma, making it one of the most common chronic diseases in the world. Asthma accounts for 250,000 deaths per year worldwide, and 1.7 million emergency room visits per year in the United States. Cost of asthma in the United States was an estimated $12.7 billion dollars per year in 1998, and the prevalence is increasing. In 2002, there were 13.9 million outpatient asthma visits to private physician offices and hospital outpatient departments, and 484,000 asthma hospitalizations. Children 5-17 years of age missed 14.7 million school days, and adults missed 11.8 million work days due to asthma in 2002.
There is no single diagnostic test or symptom that defines asthma. Asthma is a syndrome consisting of a constellation of symptoms that include wheeze, cough, shortness of breath, and chest tightness. The diagnosis of asthma takes into account history, physical examination findings, and objective measures of pulmonary function and markers of inflammation. In many cases the diagnosis is not in question, allowing for early recognition and appropriate treatment. In other cases, confounding factors makes the diagnosis both challenging and time consuming for the physician and the patient. According to the National Asthma Education and Prevention Program Expert Panel Report 2, asthma is defined as:
Read more
"a chronic inflammatory disorder of the airways in which many cells and cellular elements play a role, in particular, mast cells, eosinophils, T lymphocytes, macrophages, neutrophils, and epithelial cells. In susceptible individuals, this inflammation causes recurrent episodes of wheezing, breathlessness, chest tightness, and coughing, particularly at night or in the early morning. These episodes are usually associated with widespread but variable airflow obstruction that is often reversible either spontaneously or with treatment. The inflammation also causes an associated increase in the existing bronchial hyperresponsiveness to a variety of stimuli."
Airway obstruction and reversibility is measured by pulmonary function testing before and after inhalation of a short acting beta agonist. Airway hyperresponsiveness is measured by methacholine challenge.
Estimates of asthma prevalence are generated by the use of written questionnaires in epidemiologic studies. , One of the difficulties with reliance on questionnaires is that patients often misinterpret the questions or fail to answer the question altogether. In this study, a physician will review the questionnaire with the patient in order to clarify each question.
The goal in this study is to evaluate a simplified set of questions that can be easily implemented into clinical practice that will predict the presence or absence of asthma.
Hypothesis
A simplified questionnaire will predict asthma in adults.
Study Objectives
§ Primary Objective
- To evaluate the predictive value of a questionnaire designed to diagnose asthma in adults
- Conditions
- Asthma
- Keywords
- ASTHMA
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | ASTHMA: PREVOUSLY DIAGNOSED MILD ASTHMA PATIENTS | |
| 2 | CONTROL: PATIENTS WHO HAVE NEVER BEEN DIAGNOSED WITH ASTHMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the predictive value of a questionnaire designed to diagnose asthma in adults.
Measured: UP TO 2 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2008 (estimated)
- Study startFeb 2007
- Primary completionJun 2008
- Study completionJun 2008
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Investigators
- RICHARD F LOCKEY, MD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00620334
- Sponsor's protocol ID
- COLES
- Status last verified
- Jul 2008
- First submitted
- 7 Feb 2008
- Last updated
- 10 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting the Diagnosis of Asthma Based on History
- ClinicalTrials.gov ID
- NCT00620334
- Acronym / sponsor ID
- COLES
- Conditions
- Asthma
- Keywords
- ASTHMA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 21 Feb 2008 (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.
Despite the development of effective medications for treatment, asthma remains a significant contributor of morbidity, mortality, and financial hardship to patients with the disease. An estimated 300 million people worldwide have asthma, making it one of the most common chronic diseases in the world. Asthma accounts for 250,000 deaths per year worldwide, and 1.7 million emergency room visits per year in the United States. Cost of asthma in the United States was an estimated $12.7 billion dollars per year in 1998, and the prevalence is increasing. In 2002, there were 13.9 million outpatient asthma visits to private physician offices and hospital outpatient departments, and 484,000 asthma hospitalizations. Children 5-17 years of age missed 14.7 million school days, and adults missed 11.8 million work days due to asthma in 2002.
There is no single diagnostic test or symptom that defines asthma. Asthma is a syndrome consisting of a constellation of symptoms that include wheeze, cough, shortness of breath, and chest tightness. The diagnosis of asthma takes into account history, physical examination findings, and objective measures of pulmonary function and markers of inflammation. In many cases the diagnosis is not in question, allowing for early recognition and appropriate treatment. In other cases, confounding factors makes the diagnosis both challenging and time consuming for the physician and the patient. According to the National Asthma Education and Prevention Program Expert Panel Report 2, asthma is defined as:
"a chronic inflammatory disorder of the airways in which many cells and cellular elements play a role, in particular, mast cells, eosinophils, T lymphocytes, macrophages, neutrophils, and epithelial cells. In susceptible individuals, this inflammation causes recurrent episodes of wheezing, breathlessness, chest tightness, and coughing, particularly at night or in the early morning. These episodes are usually associated with widespread but variable airflow obstruction that is often reversible either spontaneously or with treatment. The inflammation also causes an associated increase in the existing bronchial hyperresponsiveness to a variety of stimuli."
Airway obstruction and reversibility is measured by pulmonary function testing before and after inhalation of a short acting beta agonist. Airway hyperresponsiveness is measured by methacholine challenge.
Estimates of asthma prevalence are generated by the use of written questionnaires in epidemiologic studies. , One of the difficulties with reliance on questionnaires is that patients often misinterpret the questions or fail to answer the question altogether. In this study, a physician will review the questionnaire with the patient in order to clarify each question.
The goal in this study is to evaluate a simplified set of questions that can be easily implemented into clinical practice that will predict the presence or absence of asthma.
Hypothesis
A simplified questionnaire will predict asthma in adults.
Study Objectives
§ Primary Objective
- To evaluate the predictive value of a questionnaire designed to diagnose asthma in adults
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –ASTHMA: PREVOUSLY DIAGNOSED MILD ASTHMA PATIENTS |
| 2 | – | –CONTROL: PATIENTS WHO HAVE NEVER BEEN DIAGNOSED WITH ASTHMA |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Male or female Females are eligible to participate only if they are currently non-pregnant and non-lactating. All premenopausal women will undergo a urine pregnancy test at the beginning of the study. Female subjects should not be enrolled if they plan to become pregnant during the time of the study.
Key inclusion criteria (4 listed)
- 18-64 years of age at enrollment
- Literacy: The subject must be able to read, comprehend, and record information in English.
- Consent: The subject must have the ability to give informed consent.
- Type of subject: The subject must be seen in the outpatient setting.
Key exclusion criteria (10 listed)
- Respiratory Instability: Hospitalization for respiratory disease within the last 6 months during study period and prior to Visit 0.
- Respiratory Disease: Current diagnosis of cystic fibrosis, pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, chronic bronchitis, or any other lower respiratory abnormalities other than asthma.
- Prior Treatment of Asthma: Treatment for asthma with any medication (except for short acting inhaled bronchodilators) for 12 months or more prior to Visit 0
- Drug Allergy: Any immediate or delayed hypersensitivity reaction to any beta2-agonist or sympathomimetic drug
- Respiratory Tract Infections: Confirmed or suspected infection of the sinus, middle ear, oropharynx, upper respiratory tract, or lower respiratory tract within 28 days prior to testing
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
To evaluate the predictive value of a questionnaire designed to diagnose asthma in adults.
Time frame: UP TO 2 WEEKS
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 10 Aug 2010.
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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.
RICHARD F LOCKEY, MD principal investigator
University of South Florida
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 4 inclusion and 10 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 10 Aug 2010. 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?
To evaluate the predictive value of a questionnaire designed to diagnose asthma in adults. (time frame: UP TO 2 WEEKS). 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 10 Aug 2010.