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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.

Következő lépések

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
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.

Ki nem vehet részt

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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

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (14)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
University of MichiganAnn ArborEgyesült ÁllamokIsmeretlen állapot
Johns Hopkins UniversityBaltimoreEgyesült ÁllamokIsmeretlen állapot
University of Alabama at BirminghamBirminghamEgyesült ÁllamokIsmeretlen állapot
University of Illinois at ChicagoChicagoEgyesült ÁllamokIsmeretlen állapot
National Jewish HealthDenverEgyesült ÁllamokIsmeretlen állapot
University of IowaIowa CityEgyesült ÁllamokIsmeretlen állapot
University of California at Los AngelesLos AngelesEgyesült ÁllamokIsmeretlen állapot
Columbia UniversityNew YorkEgyesült ÁllamokIsmeretlen állapot
Weill Cornell MedicineNew YorkEgyesült ÁllamokIsmeretlen állapot
Temple UniversityPhiladelphiaEgyesült ÁllamokIsmeretlen állapot
University of UtahSalt Lake CityEgyesült ÁllamokIsmeretlen állapot
University of California at San FranciscoSan FranciscoEgyesült ÁllamokIsmeretlen állapot
Mayo Clinic - ArizonaScottsdaleEgyesült ÁllamokIsmeretlen állapot
Wake Forest UniversityWinston-SalemEgyesült ÁllamokIsmeretlen állapot

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