- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01777867
Cough Reflex Sensitivity and Bronchial Hyper-responsiveness
16. februar 2017 oppdatert av: Kenneth R. DeVault, M.D., Mayo Clinic
Pilot Studies Evaluating Cough Reflex Sensitivity and Bronchial Hyper-responsiveness: The Road to Cough and Wheeze in Patients With Gastroesophageal Reflux.
The aim of this study is to provide pilot data on the possible gastrointestinal predictors of respiratory hyper-responsiveness and how these relate to the clinical sub-types of gastroesophageal reflux disease (GERD) and visceral acid hypersensitivity.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
This study recruited participants into three groups: reflux patients with non-erosive disease (NERD) with abnormal levels of acid reflux, NERD patients with normal levels of reflux and healthy volunteers.
Participants were assessed for cough reflex sensitivity (CRS) to citric acid and bronchial-hyperresponsiveness (BHR) to methacholine challenge, both before (baseline) and after esophageal acid infusion (HCl, 0.15M) or normal saline control (8ml/min).
The order of CRS and BHR was randomized, as was the order of the acid/saline infusions.
Studietype
Observasjonsmessig
Registrering (Faktiske)
24
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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Florida
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Jacksonville, Florida, Forente stater, 32224
- Mayo Clinic Florida
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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 60 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
This study will recruit participants into three groups ages 18-60 years: 12 reflux patients with non-erosive disease (NERD) with abnormal levels of acid reflux, 12 NERD patients with normal levels of reflux and 12 healthy volunteers.
Beskrivelse
Inclusion Criteria:
- symptomatic reflux (i.e., one symptom at least one day a week, with at least 'moderate' severity)
- no evidence of esophagitis
- non-smokers
Exclusion Criteria:
- previous gastrointestinal surgery (excluding minor surgeries, such as cholecystectomy, appendectomy
- active peptic ulcer disease
- Zollinger Ellison Syndrome
- Barrett's esophagus
- eosinophilic esophagitis
- cardiac disease
- diabetes or neurological deficit
- use of tricyclics
- selective serotonin reuptake inhibitors
- narcotics or benzodiazepines
- current use of medications that may affect symptoms of perception,lower esophageal sphincter basal pressure, acid clearance time or acid suppression
- antibiotics within 60 days
- Nursing mothers will be excluded
- allergies to citrus
- asthma
- chronic lung disease
- heart attack or stroke within the last three months
- hypersensitivity to methacholine products
- know aortic aneurysm
- uncontrolled hypertension (defined as systolic pressure greater than 200 or diastolic greater than 100)
- reduced pulmonary function test (forced expiratory volume in one second (FEV1) or the FEV1 to forced vital capacity (FVC) ratio (FEV1/FVC) of less that 70% of predicted value)
- None of the controls will have any GERD symptoms or ever used antireflux treatment.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
Healthy Volunteers
Subjects in this arm were healthy volunteers.
Subjects underwent both Cough Reflex Sensitivity and the Methacholine Challenge procedures.
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Subjects inhaled increasing concentrations of citric acid, which induces coughing in a dose-dependent, reproducible matter.
Following each inhalation, the number of coughs in the subsequent 15 seconds was counted and recorded.
The challenge was terminated once the citric acid induced 5 or more coughs and the logarithmic (base 10) concentration provoking 5 coughs was recorded.
A baseline spirometry was used to assess how well the participant's lungs work by measuring how much air was inhale, how much was exhale and how quickly the participant exhaled.
If this was normal, the subject inhaled slowly and deeply the methacholine test solution from a nebulizer and was told to hold their breath for 5 seconds.
This was repeated until 5 inhalations were performed in no more than two minutes.
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Non-erosive reflux disease with reflux
Subjects enrolled in this arm had non-erosive reflux disease with reflux (heartburn) for at least 6 of the preceding 12 months.
Subjects underwent both Cough Reflex Sensitivity and the Methacholine Challenge procedures.
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Subjects inhaled increasing concentrations of citric acid, which induces coughing in a dose-dependent, reproducible matter.
Following each inhalation, the number of coughs in the subsequent 15 seconds was counted and recorded.
The challenge was terminated once the citric acid induced 5 or more coughs and the logarithmic (base 10) concentration provoking 5 coughs was recorded.
A baseline spirometry was used to assess how well the participant's lungs work by measuring how much air was inhale, how much was exhale and how quickly the participant exhaled.
If this was normal, the subject inhaled slowly and deeply the methacholine test solution from a nebulizer and was told to hold their breath for 5 seconds.
This was repeated until 5 inhalations were performed in no more than two minutes.
|
Non-erosive reflux disease without reflux
Subjects enrolled in this arm had non-erosive reflux disease with normal levels of reflux (heartburn).
Subjects underwent both Cough Reflex Sensitivity and the Methacholine Challenge procedures.
|
Subjects inhaled increasing concentrations of citric acid, which induces coughing in a dose-dependent, reproducible matter.
Following each inhalation, the number of coughs in the subsequent 15 seconds was counted and recorded.
The challenge was terminated once the citric acid induced 5 or more coughs and the logarithmic (base 10) concentration provoking 5 coughs was recorded.
A baseline spirometry was used to assess how well the participant's lungs work by measuring how much air was inhale, how much was exhale and how quickly the participant exhaled.
If this was normal, the subject inhaled slowly and deeply the methacholine test solution from a nebulizer and was told to hold their breath for 5 seconds.
This was repeated until 5 inhalations were performed in no more than two minutes.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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Change in cough reflex sensitivity (CRS)
Tidsramme: baseline, approximately 4 weeks
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baseline, approximately 4 weeks
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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: Kenneth R. DeVault, MD, Mayo Clinic
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 (Faktiske)
1. desember 2012
Primær fullføring (Faktiske)
1. februar 2016
Studiet fullført (Faktiske)
1. februar 2016
Datoer for studieregistrering
Først innsendt
24. januar 2013
Først innsendt som oppfylte QC-kriteriene
24. januar 2013
Først lagt ut (Anslag)
29. januar 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. februar 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. februar 2017
Sist bekreftet
1. februar 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Sykdommer i luftveiene
- Respirasjonsforstyrrelser
- Gastrointestinale sykdommer
- Bronkiale sykdommer
- Tegn og symptomer, luftveier
- Esophageal motilitetsforstyrrelser
- Deglution lidelser
- Esophageal sykdommer
- Gastroøsofageal refluks
- Hoste
- Bronkial hyperreaktivitet
- Fysiologiske effekter av legemidler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Autonome agenter
- Agenter fra det perifere nervesystemet
- Kolinerge midler
- Kolinerge agonister
- Luftveismidler
- Miotikk
- Parasympathomimetika
- Bronkokonstriktormidler
- Muskariniske agonister
- Metakolinklorid
Andre studie-ID-numre
- 11-006873
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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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