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| Tracking Information | |||||||||
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| First Received Date ICMJE | March 8, 2008 | ||||||||
| Last Updated Date | October 29, 2009 | ||||||||
| Start Date ICMJE | February 2008 | ||||||||
| Estimated Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00635271 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Biomarkers in Exhaled Breath From Asthmatic Patients | ||||||||
| Official Title ICMJE | Identification of Biomarkers in Exhaled Breath Condensates From Asthmatic Patients | ||||||||
| Brief Summary | This study will look for a relationship between asthma and factors released from the lungs in exhaled breath. If a relationship can be established, the identified factors may be used as biomarkers to predict episodes of increased asthma symptoms so that medications can be given to prevent the onset of an asthma attack. Healthy volunteers and people who have had asthma for at least 1 year may be eligible for this study. Candidates must be between 18 and 75 years of age. Participants undergo blood tests and breathing tests. For the latter, participants breathe into a machine before and after inhaling an asthma medication called albuterol. The machine measures the volume of air the subject can breathe out. Participants also provide a sample of exhaled breath by breathing normally for up to 30 minutes while wearing a mask devised for the procedure. Pulse rate, oxygen saturation and wheezing are monitored during the breath collection.... |
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| Detailed Description | Asthma is a major public health problem that is associated with significant morbidity and mortality. Patients at increased risk for asthma decompensations include those with severe asthma that is refractory to therapy, as well as patients with poorly controlled disease due to inadequate treatment. The aim of this exploratory specimen procurement protocol is to develop a non-invasive method for the detection of asthma-specific biomarkers in exhaled breath condensates (EBC) utilizing a novel collection device that was engineered at the Johns Hopkins University Applied Physics Laboratory. Biomarkers in EBC will be identified by mass spectroscopy. We propose that the identification of biomarkers in EBC that correlate with airway inflammation and disease activity may be used to guide therapy and prevent exacerbations in asthmatic patients. |
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| Study Phase | Phase I | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Prospective | ||||||||
| Condition ICMJE | Asthma | ||||||||
| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 100 | ||||||||
| Completion Date | |||||||||
| Estimated Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Patients will be between 18 and 75 years of age, male or female, with a diagnosis of asthma for at least one year. Oxygen saturation on room air greater than or equal to 92 percent. EXCLUSION CRITERIA - ASTHMA: Diagnosis of a pulmonary disorder other than asthma (for example: chronic bronchitis, emphysema, cystic fibrosis, bronchiectasis, sarcoidosis, HIV-related lymphocytic airway inflammation). Cigarette smoking within the past 3 months or a prior history of greater than 10 cumulative pack-years. History of coronary artery disease. INCLUSION CRITERIA - HEALTHY VOLUNTEERS: Research volunteers will be between 18 and 75 years of age, male or female. Oxygen saturation on room air greater than or equal to 92 percent. EXCLUSION CRITERIA - HEALTHY VOLUNTEERS: Same as the asthmatic exclusion criteria plus a history of asthma. Reversible Airflow Obstruction (increase in FEV (1) by 12 percent and 200 cc after inhaled beta 2-agonist) |
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| Gender | Both | ||||||||
| Ages | 18 Years to 75 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00635271 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 080081, 08-H-0081 | ||||||||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE | |||||||||
| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
| Verification Date | February 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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