- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01745809
Bronchoscopy Study for Severe Asthma
28 maj 2015 uppdaterad 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.
Studieöversikt
Studietyp
Observationell
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19104
- Airways Biology Initiative at the University of Pennsylvania
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
10 severe asthma subjects matched with 10 healthy control subjects
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Kohorter och interventioner
Grupp / Kohort |
Intervention / 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.
Andra namn:
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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.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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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.
Tidsram: 1 year
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1 year
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Reynold Panettieri, MD, University of Pennsylvania
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 januari 2013
Primärt slutförande (Förväntat)
1 december 2014
Avslutad studie (Förväntat)
1 december 2014
Studieregistreringsdatum
Först inskickad
6 december 2012
Först inskickad som uppfyllde QC-kriterierna
6 december 2012
Första postat (Uppskatta)
10 december 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
1 juni 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 maj 2015
Senast verifierad
1 oktober 2011
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 814383
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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