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

NCT ID: NCT00883168

Last Updated: 2013-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1791 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2009-07-31

Brief Summary

The purpose of this study is to determine if the combination of two allergy medications (formulated azelastine/fluticasone product)is more effective than placebo or either component medication alone (azelastine or fluticasone).

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 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

Conditions

Seasonal Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

azelastine Hcl

Group Type: ACTIVE_COMPARATOR

azelastineHcl

Intervention Type: DRUG

azelastine hydrochloride 548 mg

fluticasone propionate

Group Type: ACTIVE_COMPARATOR

fluticasone propionate

Intervention Type: DRUG

fluticasone propionate 200 mcg

azelastine Hcl /fluticasone propionate

Group Type: EXPERIMENTAL

azelastine Hcl/fluticasone propionate

Intervention Type: DRUG

azelastine hydrochloride 548 mcg/fluticasone propionate 200 mcg

Interventions

Placebo

Placebo

Intervention Type: DRUG

azelastineHcl

azelastine hydrochloride 548 mg

Intervention Type: DRUG

fluticasone propionate

fluticasone propionate 200 mcg

Intervention Type: DRUG

azelastine Hcl/fluticasone propionate

azelastine hydrochloride 548 mcg/fluticasone propionate 200 mcg

Intervention Type: DRUG

Other Intervention Names

astelin; MP29-02

Eligibility Criteria

Inclusion Criteria

1. Male/female subjects 12 years of age and older

2. Provide written informed consent/pediatric assent.

3. Subjects must have moderate-to-severe rhinitis, with one or more of the following present:

1. Sleep disturbance

2. Impairment of daily activities, leisure and/or sport

3. Impairment of school or work

4. Troublesome symptoms

4. Screening Visit: Have a 12-hour reflective TNSS of at least 8 out of a possible 12 and a congestion score of 2 or 3 on Visit 1

5. Randomization Visit: For the 3 days prior to Randomization and on the morning of Randomization, the sum of the 7 consecutive reflective AM and PM TNSS assessments shall be equal to or greater than 56, with a nasal congestion score equal to or greater than 14

6. Randomization Visit: instantaneous TNSS score of at least 8 and a congestion score of at least 2 just prior to beginning the onset of action assessment

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

8. Willing and able to comply with the study requirements

9. At least a 2-year history of SAR during the current allergy season

10. The presence of IgE-mediated hypersensitivity to a prevailing, individual, seasonal pollen, confirmed by a positive response to skin prick within the last year.

11. General good health and free of any disease or concomitant treatment that could interfere with the interpretation of the study results.

12. Subjects receiving immunotherapy injections (antigen desensitization) must be on a stable maintenance regimen for at least 30 days before the first study visit

13. Subjects currently receiving sublingual immunotherapy are excluded. A 6-month washout period is required following the last dose of sublingual immunotherapy.

Exclusion Criteria

1. On Focused Nasal Examination, the presence of any superficial and moderate nasal mucosal erosion, nasal mucosal ulceration, or nasal septum perforation (Grade 1b - 4) at either the screening visit or randomization visit will disqualify the subject from the study.

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

3. Nasal surgery or sinus surgery within the previous year.

4. Chronic sinusitis - more than 3 episodes per year

5. Planned travel outside of the pollen area during the study period

6. The use of any investigational drug within 30 days prior to Visit 1. No investigational products are permitted for use during the conduct of this study

7. Presence of any hypersensitivity to drugs similar to azelastine hydrochloride or fluticasone propionate

8. Women who are pregnant or nursing

9. Women of childbearing potential who are not abstinent or not practicing a medically acceptable method of contraception* see section 6.1.1

10. Respiratory Tract Infections within 14 days prior to Visit 1

11. Respiratory Tract Infections requiring antibiotic treatment 14 days prior to Visit 1

12. Asthma (with the exception of intermittent asthma).

13. Significant pulmonary disease including COPD

14. Clinically significant arrhythmia or symptomatic cardiac conditions

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

16. Existence of any surgical or medical condition or physical or laboratory findings, might significantly alter the absorption, distribution, metabolism, or excretion of study drug; that might significantly affect the subject's ability to complete this trial; or their safety in this trial.

17. Patients with a history of glaucoma

18. Clinically relevant abnormal physical findings within 1 week of randomization may preclude compliance with the study procedures

19. Employees of the research center or private practice and their family members

20. no more than 50% of their subjects have participated in protocol MP4001, MP4002 or MP4004

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meda Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lewis M Fredane, MD

Role: STUDY_DIRECTOR

Meda Pharmaceuticals

Locations

Allergy, Asthma and Immunology Associates

Scottsdale, Arizona, United States

Clinical Research Center

Encinitas, California, United States

AABI Associates Medical Group

Fountain Valley, California, United States

Allergy & Asthma Care Center of So. Cal

Long Beach, California, United States

Allergy Research Foundation

Los Angeles, California, United States

Southern California Research

Mission Viejo, California, United States

Allergy Associates Medical Group Inc

San Diego, California, United States

Allergy and Asthma Medical Group and Research Center

San Diego, California, United States

Bensch Research Associates

Stockton, California, United States

Allergy and Asthma Clinical Research, Inc.

Walnut Creek, California, United States

Asthma and Allergy Associates

Colorado Springs, Colorado, United States

Storms Clinical Research Institute

Colorado Springs, Colorado, United States

Colorado Allergy and Asthma Centers

Denver, Colorado, United States

Clinical Research Atlanta

Atlanta, Georgia, United States

Sneeze, Wheeze and Itch Associates

Normal, Illinois, United States

Kansas City Allergy and Asthma

Overland Park, Kansas, United States

Family Allergy and Asthma Reserach

Louisville, Kentucky, United States

Northeast Medical Research Associates

North Dartmouth, Massachusetts, United States

Clinical Reseacrh Institute

Minneapolis, Minnesota, United States

The Clinical Research Center

St Louis, Missouri, United States

The Asthma and Allergy Center

Papillion, Nebraska, United States

Atlantic Research Center

Ocean City, New Jersey, United States

Princeton Center for Clinical Research

Skillman, New Jersey, United States

Research Asthma, Sinus and Allergy Centers

Warren Township, New Jersey, United States

North Carolina Clinical Research

Raleigh, North Carolina, United States

Bernstein Clinical Research Center

Cincinnati, Ohio, United States

Allergy, Asthma and Clinical Research Center

Oklahoma City, Oklahoma, United States

Clinical Research Institute of Southern Oregon, PC

Medford, Oregon, United States

Allergy and Consultants of NJ/PA

Collegeville, Pennsylvania, United States

Allergy and Clinical Immunology Associates

Pittsburgh, Pennsylvania, United States

National Allergy, Asthma and Urticaria of Charleston

Charleston, South Carolina, United States

East Tennesse Center for Clinical Research

Knoxville, Tennessee, United States

Allergy and Asthma Associates

Austin, Texas, United States

Allergy and Asthma Center of Austin

Austin, Texas, United States

AARA Research Center

Dallas, Texas, United States

Pharmaceutical Research & Consulting Inc

Dallas, Texas, United States

Western Sky Medical Research

El Paso, Texas, United States

Central Texas Health Research

New Braunfels, Texas, United States

Diagnostic Research Group

San Antonio, Texas, United States

Sylvana Research Associates

San Antonio, Texas, United States

Allergy, Asthma Research Center

San Antonio, Texas, United States

Allergy and Asthma Center

Waco, Texas, United States

Allergy Asthma Research Institute

Waco, Texas, United States

Intermountain Clinical Research

Draper, Utah, United States

Asthma, Inc.

Seattle, Washington, United States

Countries

United States

Other Identifiers

MP4006

Identifier Type: -

Identifier Source: org_study_id