- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT01697956
Hypothalamic-Pituitary-Adrenal (HPA)-Axis Study in Pediatric Subjects With Perennial Allergic Rhinitis (PAR)
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 6-Week Study Designed to Investigate the Effects of BDP Nasal Aerosol on the Hypothalamic-Pituitary-Adrenal (HPA)-Axis in Pediatric Subjects (6 to 11 Years of Age) With Perennial Allergic Rhinitis (PAR)
Tutkimuksen yleiskatsaus
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
Opiskelupaikat
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California
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Long Beach, California, Yhdysvallat
- Teva Investigational Site 10305
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Georgia
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Stockbridge, Georgia, Yhdysvallat
- Teva Investigational Site 10304
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Minnesota
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Plymouth, Minnesota, Yhdysvallat
- Teva Investigational Site 10300
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Pennsylvania
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Normal, Pennsylvania, Yhdysvallat
- Teva Investigational Site 10302
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Texas
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New Braunfels, Texas, Yhdysvallat
- Teva Investigational Site 10301
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San Antonio, Texas, Yhdysvallat
- Teva Investigational Site 10303
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- Informed consent/(assent - if applicable)
- Male or female subjects 6-11 years of age
- General good health
- A documented history of PAR to a relevant perennial allergen for a minimum of 12 months
- Other criteria apply
Exclusion Criteria:
- Pregnancy, nursing, or plans to become pregnant or donate gametes
- Participation in any investigational drug study within the 30 days preceding the Screening Visit 1 (SV1)
- Previous participation in a BDP nasal aerosol study as a randomized subject
- A known hypersensitivity to any corticosteroid or any of the excipients in the study medication formulation
- History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations
- History of a respiratory infection or disorder within the 14 days preceding the Screening Visit 1 (SV1)
- Use of any prohibited concomitant medications within the prescribed (per protocol) withdrawal periods prior to the Screening Visit 1 (SV1)
- Other criteria apply
- Current smoker or current user of tobacco products at any time during the study; history of smoking or use of tobacco products within the past year
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Nelinkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: BDP Nasal Aerosol 80 mcg/day
BDP nasal aerosol: 80 mcg dose once daily in the morning.
Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
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Beclomethasone dipropionate (BDP) 80 mcg/day (40 mcg/spray, 1 spray/nostril, once daily - total 2 sprays/day) as a nasal aerosol.
Muut nimet:
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Placebo Comparator: Placebo Nasal Aerosol
Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
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Placebo (1 spray/nostril, once daily - total 2 sprays/day) as a nasal aerosol.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Change From Baseline (Expressed As A Ratio) In 24-Hr Serum Cortisol Weighted Mean Following 6 Weeks Of Treatment
Aikaikkuna: Baseline (Day 1, -24, -22, -20, -16, -12, -8, and 0 hours prior to study medication), End of Treatment (Day 43, (Immediately prior to study medication administration (Hour 0) and at 2, 4, 8, 12, 16, and 24 hours after study medication administration)
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The serum cortisol weighted mean (0-t), calculated by dividing the area under the concentration-time curve (AUC) from time zero to the time of the last measurable value over the 24-hour period by the sample collection time interval, was determined for each participant at baseline and Week 6, and the ratio of Week 6 over baseline was derived.
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Baseline (Day 1, -24, -22, -20, -16, -12, -8, and 0 hours prior to study medication), End of Treatment (Day 43, (Immediately prior to study medication administration (Hour 0) and at 2, 4, 8, 12, 16, and 24 hours after study medication administration)
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-t ) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP)
Aikaikkuna: Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)
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Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP.
Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics.
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Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)
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Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP)
Aikaikkuna: Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)
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Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP.
Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics.
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Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)
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Maximum Plasma Concentration (Cmax) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP)
Aikaikkuna: Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)
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Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP.
Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics.
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Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)
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Time to Reach Maximum Plasma Concentration (Tmax) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP)
Aikaikkuna: Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)
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Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP.
Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics.
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Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)
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Terminal Elimination Rate Constant (λz ) for Beclomethasone-17-monopropionate (17-BMP)
Aikaikkuna: Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)
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Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP.
Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics.
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Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)
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Terminal Elimination Half-life (t1/2) for Beclomethasone-17-monopropionate (17-BMP)
Aikaikkuna: Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)
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Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP.
Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics.
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Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)
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Participants With Treatment-Emergent Adverse Events (AEs)
Aikaikkuna: Day 1- week 10
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The intensity or severity of the AE was characterized as mild (AE which is easily tolerated), moderate (AE sufficiently discomforting to interfere with daily activity) or severe (AE which prevents normal daily activities). The causal relationship was characterized as not related (no reasonable possibility that the AE was caused by or attributed to the investigational product) or related reasonable possibility that the AE was caused by or attributed to the investigational product / a causal relationship cannot be ruled out). An SAE was defined as an AE that resulted in any of the following:
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Day 1- week 10
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Participants With Shifts in Hematology Results From Normal at Screening to High or Low at End of Study
Aikaikkuna: Screening (Day -21 to -7), End of Study (Day 42)
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Shifting to 'High' refers to starting the study within normal range and being outside the high-end of normal by end of study. Conversely, shifting to 'Low' refers to starting the study within normal range and being outside the low-end of normal by end of study. MCHC = mean corpuscular hemoglobin concentration MCV = mean corpuscular volume, or mean cell volume MCH = mean corpuscular hemoglobin or mean cell hemoglobin |
Screening (Day -21 to -7), End of Study (Day 42)
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Participants With Shifts in Serum Chemistry Results From Normal at Screening to High or Low at End of Study
Aikaikkuna: Screening (Day -21 to -7), End of Study (Day 42)
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Shifting to 'High' refers to starting the study within normal range and being outside the high-end of normal by end of study. Conversely, shifting to 'Low' refers to starting the study within normal range and being outside the low-end of normal by end of study. BUN = blood urea nitrogen AST = aspartate transaminase ALT = alanine transaminase GGT = gamma-glutamyl transpeptidase |
Screening (Day -21 to -7), End of Study (Day 42)
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Yhteistyökumppanit ja tutkijat
Tutkijat
- Päätutkija: Sudeesh K Tantry, Ph.D., Teva Branded Pharmaceutical Products R&D
Julkaisuja ja hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Infektiot
- Hengitysteiden infektiot
- Hengityselinten sairaudet
- Immuunijärjestelmän sairaudet
- Yliherkkyys, välitön
- Otorinolaryngologiset sairaudet
- Hengitysteiden yliherkkyys
- Yliherkkyys
- Nenän sairaudet
- Nuha
- Nuha, allerginen
- Nuha, allerginen, monivuotinen
- Huumeiden fysiologiset vaikutukset
- Tulehdusta ehkäisevät aineet
- Glukokortikoidit
- Hormonit
- Hormonit, hormonikorvikkeet ja hormoniantagonistit
- Astmaattiset aineet
- Hengityselinten aineet
- Beklometasoni
Muut tutkimustunnusnumerot
- BDP-AR-307
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