Predicting the Diagnosis of Asthma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00620334|
Recruitment Status : Completed
First Posted : February 21, 2008
Last Update Posted : August 10, 2010
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.
A simplified questionnaire will predict asthma in adults.
§ Primary Objective
o To evaluate the predictive value of a questionnaire designed to diagnose asthma in adults
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Predicting the Diagnosis of Asthma Based on History|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||June 2008|
PREVOUSLY DIAGNOSED MILD ASTHMA PATIENTS
PATIENTS WHO HAVE NEVER BEEN DIAGNOSED WITH ASTHMA
- To evaluate the predictive value of a questionnaire designed to diagnose asthma in adults. [ Time Frame: UP TO 2 WEEKS ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00620334
|United States, Florida|
|Tampa, Florida, United States, 33613|
|Principal Investigator:||RICHARD F LOCKEY, MD||University of South Florida|