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

4. maj 2015 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

703

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

12 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
0.15% azelastine hydrochloride 1644 mcg
Medicin: 0.15% azelastine hydrochloride
1644 mcg (205.5 mcg/spray) 2 sprays per nostril twice a day/AM and PM
Eksperimentel: 2
Mometasone furoate 200 mcg
Medicin: Mometasone furoate
200 mcg (50 mcg/spray) 2 sprays per nostril Once a day (AM)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Meda Pharmaceuticals

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2007

Primær færdiggørelse (Faktiske)

1. juni 2008

Studieafslutning (Faktiske)

1. juli 2008

Datoer for studieregistrering

Først indsendt

21. juli 2008

Først indsendt, der opfyldte QC-kriterier

21. juli 2008

Først opslået (Skøn)

22. juli 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

21. maj 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. maj 2015

Sidst verificeret

1. maj 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MP436

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner