- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01439815
An Allergen BioCube (ABC) Study Evaluating the Efficacy of Fluticasone Propionate Nasal Spray Compared to Placebo
24. mars 2021 oppdatert av: ORA, Inc.
A Single-Center, Randomized, Double-Masked, Placebo-Controlled Evaluation of the Efficacy of Flonase (Fluticasone Propionate Nasal Spray) Compared to Placebo Nasal Spray in the Allergen BioCube (ABC) Model
The purpose of this study is to evaluate the onset of action of fluticasone propionate nasal spray compared to placebo nasal spray in reducing nasal allergic signs and symptoms following ragweed exposure in the Allergen BioCube (ABC) after up to 14 days of at home dosing.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
22
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Massachusetts
-
Andover, Massachusetts, Forente stater, 01810
- ORA, Inc.
-
-
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 og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- provide written informed consent and signed HIPAA form;
- be able and willing to follow all instructions and attend the study visits;
- if female and of childbearing potential, be not pregnant, nursing or planning a pregnancy, be willing to submit a pregnancy test at Visit 1 and at exit visit, and to use adequate method of birth control
- have a positive history of seasonal allergic rhinitis to ragweed;
- have a positive skin test reaction to ragweed of within the past 24 months;
- manifest sufficient allergic rhinitis symptoms during ragweed exposure in the ABC
Exclusion Criteria:
- known intolerance or allergy to antihistamines or corticosteroids;
- have a compromised lung function at Visit 1;
- develop a compromised lung function at Visits 2-6
- have any presence of active sinus or nasal infection at any visit;
- have experienced an acute upper or lower respiratory tract infection or acute sinusitis within 30 days of visit 1;
- have significant nasal anatomical deformities or any condition that does not allow subject to breathe through the nose (includes, but is not limited to: septal deviation, septal perforations, nasal polyps, rhinitis medicamentosa)
- have had any nasal surgical intervention in the past;
- have a known history of glaucoma
- have planned surgery (nasal, ocular or systemic) during the trial period or within 30 days thereafter;
- inability or refusal to discontinue contact lens wear during all visits;
- use disallowed medications during the study or appropriate pre-study washout period
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: Placebo Nasal Spray
Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16.
|
two sprays in each nostril once daily
|
|
Aktiv komparator: Fluticasone Propionate
Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16.
|
two sprays in each nostril once daily
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16)
Tidsramme: pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16
|
The change in the total sum of the four symptoms (total nasal symptom scores - TNSS) ranging from 0 to 16 with higher score indicating a more severe reaction. The change in the TNSS score between Day 0 and Day 16 was analyzed. |
pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16
Tidsramme: pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16
|
Nasal Itching was assessed by the participants pre-ABC exposure and approximately every 15 minutes while in the ABC on Day 0 and Day 16 on a 0-4 scale (0 = none to 4 = severe).
The change in average nasal itching score between Day 0 and Day 16 was analyzed.
|
pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16
|
|
Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16
Tidsramme: pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16
|
Sneezing was assessed by the participants pre-ABC exposure and approximately every 15 minutes while in the ABC on Day 0 and Day 16 on a 0-4 scale (0 = none to 4 = severe).
The change in average sneezing score between Day 0 and Day 16 was analyzed.
|
pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16
|
|
Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16
Tidsramme: pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16
|
Rhinorrhea was assessed by the participants pre-ABC exposure and approximately every 15 minutes while in the ABC on Day 0 and Day 16 on a 0-4 scale (0 = none to 4 = severe).
The change in average rhinorrhea score between Day 0 and Day 16 was analyzed.
|
pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16
|
|
Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16
Tidsramme: pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16
|
Nasal Congestion was assessed by the participants pre-ABC exposure and approximately every 15 minutes while in the ABC on Day 0 and Day 16 on a 0-4 scale (0 = none to 4 = severe).
The change in average nasal congestion score between Day 0 and Day 16 was analyzed.
|
pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Tarek Shazly, MD, ORA, Inc.
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. september 2011
Primær fullføring (Faktiske)
1. oktober 2011
Studiet fullført (Faktiske)
1. oktober 2011
Datoer for studieregistrering
Først innsendt
19. september 2011
Først innsendt som oppfylte QC-kriteriene
22. september 2011
Først lagt ut (Anslag)
23. september 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. april 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. mars 2021
Sist bekreftet
1. november 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Infeksjoner
- Luftveisinfeksjoner
- Sykdommer i luftveiene
- Sykdommer i immunsystemet
- Overfølsomhet, Umiddelbar
- Øyesykdommer
- Otorhinolaryngologiske sykdommer
- Respiratorisk overfølsomhet
- Overfølsomhet
- Nesesykdommer
- Konjunktivale sykdommer
- Rhinitt
- Rhinitt, allergisk
- Konjunktivitt
- Konjunktivitt, allergisk
- Fysiologiske effekter av legemidler
- Autonome agenter
- Agenter fra det perifere nervesystemet
- Anti-inflammatoriske midler
- Dermatologiske midler
- Bronkodilatatorer
- Anti-astmatiske midler
- Luftveismidler
- Anti-allergiske midler
- Flutikason
- Xhance
Andre studie-ID-numre
- 11-100-0007
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. .