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A Study Evaluating the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies

Information source: Meda Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Seasonal Allergic Rhinitis

Intervention: azelastine HCl/fluticasone propionate (Drug); azelastine Hcl (Drug); fluticasone propionate (Drug); placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Meda Pharmaceuticals

Official(s) and/or principal investigator(s):
Lewis M Fredane, MD, Study Director, Affiliation: Meda Pharmaceuticals

Summary

The purpose of this study is to determine if two allergy medications (formulated azelastine and fluticasone product) are more effective than placebo or either medication alone (azelastine or fluticasone)

Clinical Details

Official title: Randomized, Double-Blind Trial of MP29-02 Nasal Spray Compared to Placebo, Azelastine Hydrochloride Nasal Spray, and Fluticasone Propionate Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change From Baseline in 12 Hour Reflective Total Nasal Symptom Score (rTNSS)

Secondary outcome:

Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)

Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)

Detailed description: This will be a Phase III, randomized, double-blind, placebo-controlled, parallel-group study in subjects with moderate-to-severe seasonal allergic rhinitis (SAR). The study will begin

with a 7-day, single-blind, placebo lead-in period (Day - 7 to Day 1). Subjects will be

instructed to take placebo lead-in medication twice daily (1 spray per nostril), approximately every 12 hours. On Day 1, subjects who satisfy the symptom severity requirements and continue to meet all of the study inclusion/exclusion criteria will be randomized in a 1: 1:1: 1 ratio to receive 1 spray per nostril twice daily of MP29-02, azelastine hydrochloride, fluticasone propionate, or placebo nasal spray. Efficacy will be assessed by the change from baseline in the subject-reported 12-hour reflective Total Nasal Symptom Score (TNSS). On Days 1 through 14, subjects will rate the instantaneous and reflective TNSS symptoms of sneezing, nasal congestion, runny nose, and nasal itching; the instantaneous and reflective total ocular symptom score (TOSS) symptoms of itchy eyes, watery eyes and eye redness; the symptom of postnasal drip will be rated, reflectively, twice daily (AM and PM) in a diary prior to the dose of study medication. Symptoms will be scored on a 0 to 3 scale (0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms), such that the maximum daily symptom severity score will be 24 for the TNSS and 18 for the TOSS. Additional secondary efficacy variables will include reflective individual nasal and ocular symptom scores, as well as change from Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). Subjects ≥ 18 years of age will complete the RQLQ on Day 1 (prior to dosing) and Day 14. Subjects will return to the clinic on Day 7 for an interim evaluation. After completing the 2-week double-blind treatment period, subjects will return to the clinic on Day 14 (or at time of early termination) for an end-of-study evaluation. Safety and tolerability assessments will be made on Days 7 and 14. Tolerability will be evaluated by subject-reported adverse events (AEs), nasal examinations, and vital signs assessments.

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male and female subjects 12 years of age and older

- Provide written informed consent/pediatric assent. If the subject is a minor,

parent or legal guardian must give written informed consent

- Subjects must have moderate-to-severe rhinitis, defined as having one or more of the

following: 1. Sleep disturbance 2. Impairment of daily activities, leisure and/or sport 3. Impairment of school or work 4. Troublesome symptoms

- Screening Visit: Have a 12-hour reflective TNSS of at least 8 of 12 and a congestion

score of 2 or 3 on Visit 1

- Randomization Visit: Have a 12-hour reflective TNSS (AM or PM) of at least 8 on 3

separate symptom assessments (one of which was within 2 days of Day 1, and can include the morning of Day 1) during the Lead-in Period.

- Randomization Visit: Have an AM or PM 12-hour reflective nasal congestion score of 2

or 3 must have been recorded on 3 separate symptom assessments (one of which was within 2 days of Day 1, and can include the morning of Day 1) Randomization Visit: Have an instantaneous TNSS score of 8 or more at time point zero, just prior to beginning the onset of action assessment

- Have taken at least 10 doses of the lead-in medication

- Willing and able to comply with the study requirementsAt least a 2-year history of

SAR during Fall allergy season

- The presence of IgE-mediated hypersensitivity to a local Fall pollen, confirmed by a

positive response to skin prick within the last year. A positive response is defined as a wheal diameter of at least 3 mm larger than the negative control.

- General good health and free of disease or concomitant treatment that could interfere

with the interpretation of the study results

- Subjects receiving immunotherapy injections (antigen desensitization) must be on a

stable maintenance regimen for at least 30 days before the first study visit

- Subjects currently receiving sublingual immunotherapy are excluded. A 6-month

washout period is required following the last dose of sublingual immunotherapy. Exclusion Criteria:

- On Focused Nasal Examination, the presence of any superficial and moderate nasal

mucosal erosion, nasal mucosal ulceration, or nasal septum perforation at either the screening visit or randomization visit

- Other nasal disease(s) likely to affect deposition of intranasal medication

- Nasal surgery or sinus surgery within the previous year.

- Chronic sinusitis - more than 3 episodes per year

- Planned travel outside of the pollen area during the study period

- The use of any investigational drug within 30 days prior to Day -7.

- Presence of any hypersensitivity to drugs similar to azelastine hydrochloride or

fluticasone propionate

- Women who are pregnant or nursing

- Women of childbearing potential who are not abstinent or not practicing a medically

acceptable method of contraception*

- Respiratory Tract Infections within 14 days prior to Day -7

- Respiratory Tract Infections requiring antibiotic treatment 14 days prior to Day -7

- Asthma (with the exception of intermittent asthma).

- Significant pulmonary disease including COPD

- Clinically significant arrhythmia or symptomatic cardiac conditions

- A known history of alcohol or drug abuse within the last 2 years

- Existence of any surgical or medical condition or physical or laboratory findings

that could interfere with study result interpretation.

- Patients with a history of Glaucoma

- Clinically relevant abnormal physical findings within 1 week of randomization that

may preclude compliance with the study procedures

- Employees of the research center or private practice and their family members are

excluded

- Subjects who participated in protocol MP4001 or MP4002

Locations and Contacts

Allergy, Asthma and Immunology Associates, Scottsdale, Arizona 85251, United States

Clinical Research Center, Encinitas, California 92024, United States

AABI Associates Medical Group, Fountain Valley, California 92708, United States

William Ebbling, MD Inc, Fresno, California 93720, United States

Allergy & Asthma Care Center of So. Cal, Long Beach, California 90808, United States

Allergy Research Foundation, Los Angeles, California 90025, United States

Southern California Research, Mission Viejo, California 92691, United States

Allergy Associates Medical Group Inc, San Diego, California 92120, United States

Bensch Research Associates, Stockton, California 95207, United States

Storms Clinical Research Institute, Colorado Springs, Colorado 80907, United States

Colorado Allergy and Asthma Centers, Denver, Colorado 80230, United States

Clinical Research Atlanta, Atlanta, Georgia 30342, United States

Atlanta Allergy and Asthma Clinic, Stockbridge, Georgia 30281, United States

Clinical Research Atlanta, Stockbridge, Georgia 30281, United States

Sneeze, Wheeze and Itch Associates, Normal, Illinois 61761, United States

Kansas City Allergy and Asthma, Overland Park, Kansas 66210, United States

Northeast Medical Research Associates, North Dartmouth, Massachusetts 02747, United States

Clinical Reseacrh Institute, Minneapolis, Minnesota 55402, United States

Clinical Research Institute, Plymouth, Minnesota 55441, United States

The Clinical Research Center, St. Louis, Missouri 63141, United States

The Asthma and Allergy Center, Papillion, Nebraska 68046, United States

Atlantic Research Center, Ocean, New Jersey 07712, United States

Princeton Center for Clinical Research, Skillman, New Jersey 08558, United States

Research Asthma, Sinus and Allergy Centers, Warren, New Jersey 07059, United States

North Carolina Clinical Research, Raleigh, North Carolina 27607, United States

Bernstein Clinical Research Center, Cincinnati, Ohio 45231, United States

Allergy and Consultants of NJ/PA, Collegeville, Pennsylvania 19426, United States

Allergy and Clinical Immunology Associates, Pittsburgh, Pennsylvania 15241, United States

Asthma and Allergy Research Associate, Upland, Pennsylvania 19013, United States

National Allergy, Asthma and Urticaria of Charleston, Charleston, South Carolina 29407, United States

East Tennesse Center for Clinical Research, Knoxville, Tennessee 37909, United States

Allergy and Asthma Associates, Austin, Texas 78731, United States

Allergy and Asthma Center of Austin, Austin, Texas 78759, United States

AARA Research Center, Dallas, Texas 75231, United States

Jane Lee, MD, PA Research Center, Dallas, Texas 75246, United States

Central Texas Health Research, New Braunfels, Texas 78130, United States

Southwest Allergy and Asthma Center, P.A., San Antonio, Texas 78229, United States

Sylvana Research Associates, San Antonio, Texas 78229, United States

Intermountain Clinical Research, Draper, Utah 84020, United States

Additional Information

Starting date: August 2008
Last updated: August 7, 2012

Page last updated: August 23, 2015

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