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A Study to Evaluate Biomarkers in Chronic Obstructive Pulmonary Disease

18. februar 2013 opdateret af: MedImmune LLC

A Prospective Observational Study to Evaluate Biomarkers in Acute Exacerbations in Chronic Obstructive Pulmonary Disease

The primary objective of this study is to identify biomarkers that can be used for evaluation of efficacy in subjects presenting with AECOPD

Studieoversigt

Status

Afsluttet

Betingelser

Kronisk obstruktiv lungesygdom

Detaljeret beskrivelse

Identify biomarkers that can be used for evaluation of efficacy in subjects presenting with AECOPD by evaluating longitudinal changes and the interrelationship of blood and sputum biomarkers with physiological endpoints and symptom measures in stable subjects with COPD likely to experience a future AECOPD, and in subjects during severe AECOPD.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

Kontakter og lokationer

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

Studiesteder

Canada
- Quebec
  - Sainte-Foy, Quebec, Canada, G1V 4G5
    - Research Site
Forenede Stater
- Maryland
  - Baltimore, Maryland, Forenede Stater, 21201
    - Research Site
- Massachusetts
  - Springfield, Massachusetts, Forenede Stater, 01199
    - Research Site
- Missouri
  - St. Louis, Missouri, Forenede Stater, 63110
    - Research Site
- New York
  - Buffalo, New York, Forenede Stater, 14215
    - Research Site
- Ohio
  - Cincinnati, Ohio, Forenede Stater, 45267
    - Research Site
- Pennsylvania
  - Philadelphia, Pennsylvania, Forenede Stater, 19140
    - Research Site
  - Pittsburgh, Pennsylvania, Forenede Stater, 15213
    - Research Site
- Rhode Island
  - Providence, Rhode Island, Forenede Stater, 02903
    - Research Site
- Texas
  - Houston, Texas, Forenede Stater, 77030
    - Research Site

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

40 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The subjects in this study will be adult males or females, ≥40 years of age, at increased risk for AECOPD (Cohort 1) or who present with severe AECOPD requiring hospitalization (Cohort 2).

Beskrivelse

Inclusion Criteria:

Age ≥ 40 years at the time of screening
Written informed consent and any locally required authorization (eg, HIPAA in the USA, EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
Cohort 1 only: A primary diagnosis of clinically stable physician-diagnosed COPD upon entry into the study meeting one of the following criteria:
Subjects who have experienced a severe AECOPD requiring inpatient hospitalization in the previous 12 months
Subject who had one severe AECOPD requiring ED visits in the past 9 months
Subjects who are currently on LTOT.
Cohort 1 only: Stable COPD for 4 weeks prior to screening, as defined by no change in ICS therapy and no use of oral corticosteroids or antibiotics for a respiratory tract infection.
Cohort 1 only: Forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) < 0.70 or lower limits of normal (LLN).
Cohort 1 only: FEV1 < 60% predicted normal value.
Cohort 2 only: A primary diagnosis of physician-diagnosed AECOPD requiring admission to the hospital.
Current smoker or ex-smoker with a tobacco history of ≥ 10 pack-years (one pack year = 20 cigarettes smoked per day for 1 year).
Ability and willingness to complete the appropriate follow-up period of time as required by the protocol.
Able to read and write and use the electronic devices (English or Spanish version).

Exclusion Criteria:

Participation (defined as administration of at least one dose of investigational product) in another clinical study, the last follow-up visit of which is within 12 weeks (for a small molecule drug) and (6 months for a large molecule drug) of entry into this study.
Any condition that, in the opinion of the investigator would interfere with interpretation of subject safety or study results.
Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
The presence of another chronic pulmonary or systemic disease, which in the opinion of the investigator or medical monitor might affect the analysis of the data (eg, idiopathic pulmonary fibrosis, sarcoidosis, active cancer or autoimmune disease).
History of immunodeficiency.
Current alcohol or drug abuse or a history of unsuccessfully treated alcohol or drug abuse within the past year.
Cohort 2 only: Diagnosis of an acute disease/condition (eg, congestive heart failure, acute myocardial infarction, pneumonia, or pulmonary embolus) that is the primary reason for the subject's hospitalization.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal grupper/kohorter

Kohorter og interventioner

Gruppe / kohorte
Cohort 2 Subjects who are recruited on admission to hospital for AECOPD.
Cohort 1 Subjects with COPD who are stable, but at risk of presenting with an AECOPD.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Identify biomarkers for evaluation of efficacy in subjects presenting with AECOPD Tidsramme: 12 months	Investigate changes in physiological measures, symptoms, and blood, urine and sputum biomarkers in subjects with stable COPD during AECOPD, and as subjects return to clinical stability.	12 months

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Hospitalization, treatment and discharge of COPD subjects Tidsramme: 12 months	Gain an understanding of the reasons subjects with COPD may be hospitalized for their AECOPD and to understand the criteria physicians use for treatment and discharge.	12 months

Samarbejdspartnere og efterforskere

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

Sponsor

MedImmune LLC

Efterforskere

Studieleder: Joseph Parker, MD, MedImmune LLC

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. februar 2011

Primær færdiggørelse (Faktiske)

1. november 2012

Studieafslutning (Faktiske)

1. januar 2013

Datoer for studieregistrering

Først indsendt

28. december 2010

Først indsendt, der opfyldte QC-kriterier