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A Study to Evaluate the Safety and Tolerability of a Nasal Spray to Treat Perennial Allergic Rhinitis

4. mai 2015 oppdatert av: Meda Pharmaceuticals

Active Controlled Trial of the Safety and Tolerability of MP 03-036 (Astepro 0.15%) in Patients With Perennial Allergic Rhinitis

The purpose of this study is to determine if one allergy treatment (0.15% azelastine hydrochloride) is as safe as mometasone furoate (nasonex) alone.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

703

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Alabama
      • Oxford, Alabama, Forente stater, 36203
        • Center of Research Excellence, LLC
    • California
      • Fountain Valley, California, Forente stater, 92708
        • AABI Associates Medical Group
      • Huntington Beach, California, Forente stater, 92647
        • Allergy and Asthma Specialist Medical Group
      • Long Beach, California, Forente stater, 90806
        • West Coast Clinical Trials
      • Los Angeles, California, Forente stater, 90025
        • Allergy Research Foundation
      • Mission Viejo, California, Forente stater, 92691
        • Southern California Research
      • San Diego, California, Forente stater, 92120
        • Allergy Associates Medical Group Inc
      • San Diego, California, Forente stater, 92123
        • Allergy and Asthma Medical Group and Research Center
      • San Jose, California, Forente stater, 95117
        • Allergy & Asthma Associates of Santa Clara Valley Research Cntr
      • Stockton, California, Forente stater, 95207
        • Bensch Research Associates
      • Walnut Creek, California, Forente stater, 94598
        • Allergy and Asthma Clinical Research, Inc.
    • Colorado
      • Colorado Springs, Colorado, Forente stater, 80907
        • Asthma and Allergy Associates
    • Florida
      • Ocala, Florida, Forente stater, 34471
        • Allergy and Asthma Care of Florida
      • Tallahassee, Florida, Forente stater, 32308
        • Allergy and Asthma DTC
    • Georgia
      • Albany, Georgia, Forente stater, 31707
        • Georgia Pollens Clinical Research Centers Inc
      • Savannah, Georgia, Forente stater, 31406
        • Aeroallergy Research Laboratories of Savannah
      • Stockbridge, Georgia, Forente stater, 30281
        • Clinical Research Atlanta
    • Illinois
      • Normal, Illinois, Forente stater, 61761
        • Sneeze, Wheeze and Itch Associates
    • Kansas
      • Overland Park, Kansas, Forente stater, 66210
        • Kansas City Allergy and Asthma
    • Louisiana
      • Metairie, Louisiana, Forente stater, 70001
        • RX R+D
    • Maryland
      • Wheaton, Maryland, Forente stater, 20902
        • Institute for Asthma and Allergy PC
    • Massachusetts
      • North Dartmouth, Massachusetts, Forente stater, 02747
        • Northeast Medical Research Associates
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55402
        • Clinical Research Institute
      • Plymouth, Minnesota, Forente stater, 55441
        • Clinical Research Institute
    • Missouri
      • St. Louis, Missouri, Forente stater, 63141
        • The Clinical Research Center
    • Nebraska
      • Papillion, Nebraska, Forente stater, 68046
        • The Asthma and Allergy Center
    • Nevada
      • Henderson, Nevada, Forente stater, 89052
        • Las Vegas Physicians Research Group
    • New Jersey
      • Mount Laurel, New Jersey, Forente stater, 08054
        • Allergy and Asthma Research NJ inc
      • Ocean, New Jersey, Forente stater, 07712
        • Atlantic Research Center
      • Teaneck, New Jersey, Forente stater, 07666
        • Dr. Perin
    • New York
      • North Syracuse, New York, Forente stater, 13212
        • Medical Research Associates of CNY, PLLC
      • Rochester, New York, Forente stater, 14618
        • AAIR Research Center
    • North Carolina
      • Raleigh, North Carolina, Forente stater, 27612
        • Wake Research Associates, LLC
      • Raleigh, North Carolina, Forente stater, 27607
        • North Carolina Clinical Research
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45231
        • Bernstein Clinical Research Center
      • Cincinnati, Ohio, Forente stater, 45252
        • New Horizon's Clinical Research
    • Oklahoma
      • Edmond, Oklahoma, Forente stater, 73003
        • Oklahoma Institute of Allergy and Asthma Clinical
      • Oklahoma City, Oklahoma, Forente stater, 73120
        • Allergy, Asthma and Clinical Research Center
    • Oregon
      • Lake Oswego, Oregon, Forente stater, 97035
        • Allergy Asthma and Dermatology Research
      • Medford, Oregon, Forente stater, 97504
        • Clinical Research Institute of Southern Oregon, PC
    • Pennsylvania
      • Blue Bell, Pennsylvania, Forente stater, 19422
        • Allergy and Asthma Specialist PC
      • Collegeville, Pennsylvania, Forente stater, 19426
        • Allergy and Consultants of NJ/PA
      • Pittsburgh, Pennsylvania, Forente stater, 15241
        • Allergy and Clinical Immunology Associates
      • Upland, Pennsylvania, Forente stater, 19013
        • Asthma and Allergy Research Associate
    • Rhode Island
      • Providence, Rhode Island, Forente stater, 02906
        • Asthma, Nasal Disease & Allergy Research Center of New England
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29407
        • National Allergy, Asthma and Urticaria of Charleston
    • Texas
      • Austin, Texas, Forente stater, 78731
        • Allergy and Asthma Associates
      • Dallas, Texas, Forente stater, 75231
        • AARA Research Center
      • Dallas, Texas, Forente stater, 75231
        • Pharmaceutical Research & Consulting Inc
      • El Paso, Texas, Forente stater, 79902
        • Western Sky Medical Research
      • Houston, Texas, Forente stater, 77074
        • SWAAA Research Center
      • New Braunfels, Texas, Forente stater, 78130
        • Central Texas Health Research
      • San Antonio, Texas, Forente stater, 78229
        • Biogenics Research Institute
      • San Antonio, Texas, Forente stater, 78229
        • Sylvana Research Associates
      • San Antonio, Texas, Forente stater, 78233
        • Live Oak Allergy and Asthma Clinic
      • Waco, Texas, Forente stater, 76712
        • Allergy Asthma Research Institute
    • Virginia
      • Richmond, Virginia, Forente stater, 23229
        • VA Adult and Pediatric Allergy and Asthma
    • Washington
      • Seattle, Washington, Forente stater, 98105
        • ASTHMA, Inc.
    • Wisconsin
      • Milwaukee, Wisconsin, Forente stater, 53209
        • Advanced Healthcare

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

12 år og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Male and female patients 12 years and older with a compatible history greater than or equal to 1 year of rhinitis due to perennial allergies.
  • Must be willing and able to provide informed consent and to participate in all study procedures
  • Must be in generally good health
  • Positive skin test to a prevalent perennial allergen

Exclusion Criteria:

  • On nasal examination, the presence of nasal mucosal erosion, nasal ulceration or nasal septal perforation
  • Use of any investigational drug within 30 days of the first visit
  • Any nasal surgery or sinus surgery within the previous year
  • Presence of any hypersensitivity to drugs similar to azelastine or mometasone furoate and to either sorbital or sucralose
  • Women who are pregnant or nursing
  • Women who are not using an acceptable method of birth control
  • Nasal Diseases likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa or clinically significant nasal polyposis or nasal structural abnormalities.
  • Asthma or other lung diseases such as COPD. Mild asthma symptoms may be considered after consultation with investigator.
  • Patients with Arrythmia
  • Patients with know history of alcohol and drug abuse
  • Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor, might significantly alter the evaluation of the study.
  • Use of medications that could affect the study results

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 1
0.15% azelastine hydrochloride 1644 mcg
Legemiddel: 0.15% azelastine hydrochloride
1644 mcg (205.5 mcg/spray) 2 sprays per nostril twice a day/AM and PM
Eksperimentell: 2
Mometasone furoate 200 mcg
Legemiddel: Mometasone furoate
200 mcg (50 mcg/spray) 2 sprays per nostril Once a day (AM)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline on Direct Visual Nasal Exams to 12 Months
Tidsramme: Change from baseline to 12 months
Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irritation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation
Change from baseline to 12 months

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline to 12 Months in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Subjects 18 Years of Age and Older
Tidsramme: change from baseline to 12 months

A 28-item RQLQ was completed on Day 1, Month 1, Month 3, Month 6, month 9 and month 12 or Early termination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time.

Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items.
change from baseline to 12 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Meda Pharmaceuticals

Etterforskere

  • Studieleder: Lewis M. Fredane, MD, Meda Pharmaceuticals

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. mars 2007

Primær fullføring (Faktiske)

1. juni 2008

Studiet fullført (Faktiske)

1. juli 2008

Datoer for studieregistrering

Først innsendt

21. juli 2008

Først innsendt som oppfylte QC-kriteriene

21. juli 2008

Først lagt ut (Anslag)

22. juli 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

21. mai 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. mai 2015

Sist bekreftet

1. mai 2015

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • MP436

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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