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Factors That Affect the Development of COPD Symptoms

15. juni 2018 opdateret af: Washington University School of Medicine

Specialized Center of Clinically Oriented Research: Alveolar and Airway Mechanisms of COPD. Airway Determinants: Innate Immune Signaling (Project 4)

Chronic obstructive pulmonary disease (COPD) is the fourth most common cause of death in the United States. There is no cure and the disease gets worse over time. Although it usually occurs in people who smoke cigarettes, researchers do not know exactly how smoking leads to COPD. This study will compare blood and tissue samples from smokers and nonsmokers with and without COPD to determine why some COPD symptoms occur in some people and not others.

Studieoversigt

Status

Afsluttet

Detaljeret beskrivelse

COPD is a chronic lung disease in which the lungs' airways and balloon-like air sacs, called alveoli, are damaged, lose their shape, and become floppy. As a result, they cannot fully inflate to allow the maximum amount of air through. COPD is usually the result of many years of cigarette smoking. Breathing in other kinds of lung irritants, such as pollution, dust, or chemicals, over a long period of time may also cause or contribute to COPD. Some people with COPD have an excess of mucus in their lungs, possibly caused by an overactive immune response, which can lead to coughing and shortness of breath. Although cigarette smoking seems to make this symptom worse, researchers are not sure why it occurs in some people and not others. This study will examine and compare blood and lung tissue samples from smokers and nonsmokers with and without COPD to determine what physiological differences, environmental factors, genes, and biomarkers contribute to the development of and symptoms associated with COPD.

Before their scheduled lung resection surgery, participants in this study will attend one study visit. It will last approximately 1 to 2 hours and will consist of answering questions about medical history, filling out health questionnaires, and providing a blood sample. After the surgery, study researchers will take the lung tissue that was removed and examine it in a laboratory. Participants will be contacted by study staff if, when examining the lung tissue, researchers discover that a participant has a medical disorder that current treatment can stop or improve. Also, participants will be contacted at the end of the study to answer brief questions about their health.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

82

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Missouri
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Washington University School of Medicine

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

People in this study will be invited to participate if they plan to undergo lung resection surgery at BJH.

Beskrivelse

Inclusion Criteria:

  • Ability to read and write in English
  • Able to participate in the informed consent process
  • Planned lung resection at BJH
  • Acceptable pulmonary function tests done at BJH within 1 month of enrollment
  • Acceptable chest CT scan done at BJH within 3 years of enrollment

Exclusion Criteria:

  • Pregnant
  • Prisoner
  • Vulnerable populations
  • Clinically significant lung disease other than COPD and the indication for resection (e.g., cystic fibrosis, bronchiectasis, obliterative bronchiolitis, airway lesion)
  • Coexisting active chronic inflammatory or collagen vascular disease, immune deficiency of any kind, or previous organ transplant
  • Known active hepatitis B, hepatitis C, or HIV/AIDS (not prospectively evaluated)
  • Systemic chemotherapy within past 1 month (30 days)
  • Hematologic malignancy or thoracic radiation within past year

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
COPD
Participants in this group will be people who have COPD and plan to undergo lung resection surgery at Barnes-Jewish Hospital (BJH).
Control
Participants in this group will be people who do not have COPD and plan to undergo lung resection surgery at BJH.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Michael J. Holtzman, MD, Pulmonary and Critical Care, Washington University School of Medicine

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2007

Primær færdiggørelse (Faktiske)

1. februar 2016

Studieafslutning (Faktiske)

1. februar 2016

Datoer for studieregistrering

Først indsendt

20. august 2008

Først indsendt, der opfyldte QC-kriterier

20. august 2008

Først opslået (Skøn)

22. august 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. juni 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juni 2018

Sidst verificeret

1. juni 2018

Mere information

Begreber relateret til denne undersøgelse

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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