NCT01969344Fut, nem toboroz
Study of COPD Subgroups and Biomarkers
Subpopulations and Intermediate Outcome Measures in COPD Study
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. nov. 13.
Rövid összefoglaló (regiszter, angolul)
SPIROMICS I, SPIROMICS II, and SPIROMICS III are longitudinal observational studies of Chronic Obstructive Pulmonary Disease (COPD) cohort. SPIROMICS I had two primary aims: (1) To find groups of patients with COPD who share certain characteristics; (2) To find new ways of measuring whether or not COPD is getting worse and to provide new ways of testing whether a new treatment is working. SPIROMICS II had three primary aims: (1) To define the natural history of "smokers with symptoms despite preserved spirometry" and characterize the airway mucus abnormalities underlying this condition; (2) To determine the radiographic precursor lesion(s) for emphysema and identify the molecular phenotypes underlying airway disease and emphysema; (3) To advance understanding of the biology of COPD exacerbations through analysis of predisposing baseline phenotypes, exacerbation triggers and host inflammatory response. SPIROMICS III has three primary aims: (1) To identify the main forms of smoking-related airway disease that are caused by pathological airway mucus, their biological underpinnings, and their physiological significance; (2) To identify longitudinal trajectories in established and novel CT measures of emphysema, test how they predict COPD progression, and define their underlying biology; (3) To identify environmental and social determinants of health that impact disease severity and progression and their influence on lung structure, biology, and health disparities in COPD.
- Állapot (regiszter)
- Fut, nem toboroz
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 2981 (tényleges)
- Első benyújtás
- 2013. okt. 16.
- Kezdés
- 2010. nov.
- Elsődleges befejezés
- 2031. jún. 17.
- Fő szponzor
- University of North Carolina, Chapel Hill
- Betegségek
- Krónikus obstruktív tüdőbetegség (COPD)
- NCT-szám
- NCT01969344
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Bevont résztvevők: 2981
- 2010. nov. és az elsődleges befejezés (2031. jún. 17.) között
- 14 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Prior significant difficulties with pulmonary function testing
- Currently taking >=10mg a day/20mg every other day of prednisone or equivalent systemic corticosteroid
- Currently taking any immunosuppressive agent
- Participants who present with current use of acute antibiotics or steroids can complete the study visit ≥30 days after discontinuing acute antibiotics/steroids. This does not apply to participants who are on chronic prednisone therapy of <10 mg per day or <20 mg every other day or participants who are currently on chronic, prophylactic, or suppressive antibiotic therapy.
Más betegség
- Dementia or other cognitive dysfunction which in the opinion of the investigator would prevent the participant from consenting to the study or completing study procedures
- Smoking history of > 1 pack-year but <21 pack-years
- Hypersensitivity to or intolerance of albuterol sulfate or ipratropium bromide or propellants or excipients of the inhalers
- Non-COPD obstructive lung disease, severe kyphoscoliosis, neuromuscular weakness, or other conditions, including clinically significant cardiovascular and pulmonary disease, that, limit the interpretability of the pulmonary function measures.
- History of Interstitial lung disease
- History of Lung volume reduction surgery or lung resection
- History of lung or other organ transplant
- History of endobronchial valve therapy
- History of large thoracic metal implants (e.g., AICD (automatic implantable cardioverter/defibrillator) and/or pacemaker)
- History of or current use of IV Ritalin
- History of or current use of heroin
- History of illegal IV drug use within the last 10 years or more than 5 instances of illegal IV drug use ever
- Known HIV/AIDS infection
- History of lung cancer or any cancer that spread to multiple locations in the body
- History of or current exposure to chemotherapy or radiation treatments that, in the opinion of the investigator, limits the interpretability of the pulmonary function measures.
- Diagnosis of unstable cardiovascular disease including myocardial infarction in the past 6 weeks, uncontrolled congestive heart failure, or uncontrolled arrhythmia
- Any illness expected to cause mortality in the next 3 years
- Active pulmonary infection, including tuberculosis
- History of pulmonary embolism in the past 2 years
- Participants who present with an upper respiratory infection, either solely participant-identified or that has been clinically treated, in the last six weeks, can complete the study visit once a six-week window has passed.
- Participants who present with a myocardial infarction or eye, chest or abdominal surgery within six weeks can complete the study visit after a six-week window has passed.
Egyéb
- Plans to leave the area in the next 3 years
- BMI > 40 kg/m2 at baseline exam
- Current illicit substance abuse, excluding marijuana
- Known diagnosis of primary bronchiectasis
- Currently institutionalized (e.g., prisons, long-term care facilities)
- Known to be a first degree relative of another, already enrolled participant (i.e., biological parent, biological sibling)
- Never smokers only: Current diagnosis of asthma
- Women only: Cannot be pregnant at baseline or plan to become pregnant during the course of the study
- Temporal Exclusion Criteria for SPIROMICS III:
- Participants who present with a pulmonary exacerbation, either solely participant-identified or that has been clinically treated, in the last six weeks, can complete the study visit once a six-week window has passed.
- Female participants who present <3 months after giving birth will be asked to schedule the visit once three months have passed post-delivery.
Kiket keres a vizsgálat
- Between 40 and 80 at baseline visit
- Never smokers: <1 pack-year history of smoking
- Never smokers: Must meet lung function criteria based on spirometry without inhaled bronchodilators
- Current or former smokers: >20 pack-year history of smoking
- Current or former smokers: Must meet lung function criteria based on spirometry with inhaled bronchodilators
Életkor a regiszterben: 40 év – 80 év · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (14)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| University of Michigan | Ann Arbor | Egyesült Államok | Ismeretlen állapot |
| Johns Hopkins University | Baltimore | Egyesült Államok | Ismeretlen állapot |
| University of Alabama at Birmingham | Birmingham | Egyesült Államok | Ismeretlen állapot |
| University of Illinois at Chicago | Chicago | Egyesült Államok | Ismeretlen állapot |
| National Jewish Health | Denver | Egyesült Államok | Ismeretlen állapot |
| University of Iowa | Iowa City | Egyesült Államok | Ismeretlen állapot |
| University of California at Los Angeles | Los Angeles | Egyesült Államok | Ismeretlen állapot |
| Columbia University | New York | Egyesült Államok | Ismeretlen állapot |
| Weill Cornell Medicine | New York | Egyesült Államok | Ismeretlen állapot |
| Temple University | Philadelphia | Egyesült Államok | Ismeretlen állapot |
| University of Utah | Salt Lake City | Egyesült Államok | Ismeretlen állapot |
| University of California at San Francisco | San Francisco | Egyesült Államok | Ismeretlen állapot |
| Mayo Clinic - Arizona | Scottsdale | Egyesült Államok | Ismeretlen állapot |
| Wake Forest University | Winston-Salem | Egyesült Államok | Ismeretlen állapot |
Kapcsolódó publikációk
- Systemic Platelet Activation and Respiratory Exacerbations, Pulmonary Symptoms, and Mortality among Current and Former Smokers in SPIROMICS.Ann Am Thorac Soc · 2026 · PMID 42690694
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