- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01745809
Bronchoscopy Study for Severe Asthma
28. mai 2015 oppdatert av: University of Pennsylvania
An Exploratory Study to Obtain Functional and Transcriptional/Translational Profiling of Cells From Bronchial Lavages and Brushings in Severe Asthmatics and Healthy Control Subjects
The purpose of this research study is to collect lung tissue and fluid from two groups of people: those who have severe asthma, and those who do not.
These samples will then be tested in a laboratory to identify differences in the lung tissue cells and fluids that may exist between these two groups of people.
Studieoversikt
Status
Tilbaketrukket
Forhold
Intervensjon / Behandling
Studietype
Observasjonsmessig
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
- Airways Biology Initiative at the University of Pennsylvania
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
10 severe asthma subjects matched with 10 healthy control subjects
Beskrivelse
Inclusion Criteria:
Asthma Subject Inclusion Criteria
- Subject is an adult male or female between 18 and 65 years of age inclusive.
- Subject must have a pre-history of a physician's diagnosis of severe asthma (according to GINA classification) with some reversible airway obstruction (shown by peak flow or FEV1 in the last 12 months with a change of 12% in the absolute FEV1 measurement) and an exclusion of other significant pulmonary diseases (i.e., cystic fibrosis, tuberculosis, Interstitial Lung Disease and bronchopulmonary dysplasia)
- Subject has a positive methacholine test (PC20 < 16). This test sometimes cannot be performed in severe asthmatics because of low baseline FEV1 (< FEV1 50%). SABA reversibility of FEV1 is sufficient to define asthma in absence of MCh PC20.
- Subject's asthma has been stable for the past 30 days.
- The subject has been a non-smoker for the past year and should have less than a 10 pack year history.
- The subject must be capable of and willing to provide written informed consent
- The subject is able to understand and comply with protocol requirements and timetables, instructions and protocol-stated restrictions.
Healthy Subject Inclusion Criteria
- Subject is an adult male or female between 18 and 65 years of age inclusive. (Subjects will be age and gender matched) With age matching, we will enroll in a manner that age and gender will be matched 1:1 in the following cohorts: age 21-30, 31-40, 41-50, 51-60, 61-65.
- Subject must have an exclusion of asthma or other significant pulmonary diseases (i.e., cystic fibrosis, tuberculosis, Interstitial Lung Disease and bronchopulmonary dysplasia)
- The subject has been a non-smoker for the past year and should have less than a 10 pack year history.
- The subject has a negative methacholine test (PC20 > 16) and does not use inhaled steroids and/or SABA.
- The subject must be capable of and willing to provide written informed consent
The subject is able to understand and comply with protocol requirements and timetables, instructions and protocol-stated restrictions.
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Exclusion Criteria:
- As a result of the medical interview, physical examination or screening investigations, the physician responsible considers the volunteer unfit for the study.
- The subject has received an investigational drug or participated in any other research trial within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer), prior to the current study.
- No oral steroids within the last 3 months.
- No current anticoagulant and/or antiplatelet therapy.
- The subject has a history of alcohol or drug abuse within the last 5 years.
- The subject has history of hepatitis B, hepatitis C, or HIV virus.
- The subject has a history of chemotherapy or radiotherapy within the last 2 years.
- The subject has a history of diabetes.
- The subject is pregnant or lactating.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
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Severe Asthmatics
Subjects with a pre-existing physician diagnosis of asthma with reversible airflow obstruction of at least 12%.
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Subjects will have a screening visit and, if they qualify to take part in the study, they will undergo a single bronchoscopy procedure.
During the bronchoscopy, bronchoalveolar lavage (BAL) and bronchial brushings will be performed on each subject.
Andre navn:
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Healthy non-smokers
Subjects will be never smokers or former smokers for the past year and less than 10 pack years lifetime with no history of asthma or any other lung disease.
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Subjects will have a screening visit and, if they qualify to take part in the study, they will undergo a single bronchoscopy procedure.
During the bronchoscopy, bronchoalveolar lavage (BAL) and bronchial brushings will be performed on each subject.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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To obtain bronchial brushings and bronchial alveolar lavage fluid from 10 subjects with severe asthma (GINA criteria in The Global Initiative for Asthma, http://www.ginasthma.org ) and from 10 matched normal healthy subjects.
Tidsramme: 1 year
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1 year
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Reynold Panettieri, MD, University of Pennsylvania
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2013
Primær fullføring (Forventet)
1. desember 2014
Studiet fullført (Forventet)
1. desember 2014
Datoer for studieregistrering
Først innsendt
6. desember 2012
Først innsendt som oppfylte QC-kriteriene
6. desember 2012
Først lagt ut (Anslag)
10. desember 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
1. juni 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. mai 2015
Sist bekreftet
1. oktober 2011
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 814383
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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