A Non-drug Study Profiling Asthma
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Purpose
The objective of this study is to characterize the clinical, physiologic, and molecular profiles of healthy volunteers and patients with mild, moderate, and severe asthma.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma Health |
Other: All patients |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Primary Purpose: Basic Science |
| Official Title: | A Multicenter Longitudinal Study for the Disease Profiling of Asthma |
- Blood samples for routine laboratory tests [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
- Pulmonary function testing, assessment of airway reactivity [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
- Evaluation of DNA, RNA, and other biomarkers (for some study participants) [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 180 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: All patients
All patients will be observed and receive the same medical tests as outlined in description section
|
Other: All patients
All patients will be observed and receive the same medical tests as outlined in description section
|
Detailed Description:
This is a multi-center longitudinal exploratory study of biomarkers, clinical and physiological parameters in patients with mild, moderate, severe asthma and healthy control volunteers. There is no therapeutic intervention and this protocol will not restrict or introduce any medical interventions including medications. Study participants will undergo procedures that include pulmonary function testing, assessment of airway reactivity, blood samples for routine laboratory tests, biomarkers and DNA evaluation (for some study participants), induced sputum collection, and exhaled nitric oxide collection. All patients with asthma will have additional follow-up visits at 3, 6, and 12 months for repeat sample collection for biomarker analysis and the assessment of clinical and physiological parameters. Up to thirty patients from each asthma severity group and all healthy volunteers will undergo a bronchoscopy for collection of endobronchial biopsy and brushing samples. These samples will be used for analysis of proteins, RNA and other biomarkers in endobronchial tissue and epithelial cells. This is a non-drug study. Healthy volunteers will be in the study for approximately 1 month. Asthmatic patients will be in the study for approximately 1 year.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Sign an informed consent indicating understanding of the purpose of and procedures required for the study and are willing to participate in the study
- Be willing and able to adhere to the study visit schedule and other protocol requirements
- Have no clinically significant abnormalities as determined by medical history, physical examination, and laboratory assessments
Exclusion Criteria:
- History of any clinically significant medical illness or medical disorders that place the patient at risk
- Diagnosis of COPD, cystic fibrosis, or other significant respiratory disorder
- Major or traumatic surgery within 12 weeks of screening
- A known history of sleep apnea requiring medical intervention
- Have a recent history (within previous 6 months) of alcohol or drug abuse
Contacts and Locations| Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: | JNJ.CT@sylogent.com |
Show 21 Study Locations| Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
More Information
Additional Information:
No publications provided
| Responsible Party: | Janssen Research & Development, LLC |
| ClinicalTrials.gov Identifier: | NCT01274507 History of Changes |
| Other Study ID Numbers: | CR017362, NOCOMPOUNDASH0001 |
| Study First Received: | October 28, 2010 |
| Last Updated: | October 12, 2012 |
| Health Authority: | United States: Institutional Review Board Germany: Ethics Commission |
Keywords provided by Janssen Research & Development, LLC:
|
asthma mild moderate |
severe healthy bronchoscopy, induced sputum |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on October 18, 2012
