Clinical trial NCT00720278: A Study to Evaluate the Safety and Efficacy of Two Nasal Sprays to Treat Seasonal Allergies
Official title: Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 and MP03-33 Compared to Placebo in Patients With Seasonal Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: Meda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-07-22
Enrollment: 526
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine if two allergy medications are more effective than placebo.


Eligibility criteria: Inclusion Criteria:

1. Male and female patients 12 years of age and older
2. Provide written informed consent/pediatric assent. If the patient is a minor, a parent or legal guardian must give written informed consent
3. 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 Day -7
4. 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. In addition, 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)
5. Randomization Visit: An instantaneous TNSS of ≥ 8 before beginning the onset of action assessment on Day 1
6. Must have taken at least 10 doses of study medication during the lead-in period
7. Willing and able to comply with the study requirements
8. At least a 2-year history of SAR
9. The presence of IgE-mediated hypersensitivity to ragweed antigen or other local fall allergens, confirmed by a positive response to either 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 for the skin prick test.
10. General good health and free of any disease or concomitant treatment that could interfere with the interpretation of the study results as determined by the investigator or the sponsor's medical officer. When in doubt, the investigator should confer with the sponsor's medical monitor or designee to determine eligibility for the study.
11. Patients receiving immunotherapy injections (antigen desensitization) must be on a stable maintenance regimen for at least 30 days before the first study visit (adjustments to regimen following a brief period of missed injections does not preclude participation). Patients 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 nasal mucosal erosion, nasal ulceration, or nasal septal perforation at either the screening visit or randomization visit will disqualify the patient from the study.
2. Other nasal disease(s) likely such as sinusitis, rhinitis medicamentosa, clinically significant polyposis, or nasal structural abnormalities.
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 study area during the study period
6. The use of any investigational drug within 30 days prior to Day -7. No investigational products are permitted for use during the conduct of this study
7. Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose (Splenda® brand sweetener)
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
10. Respiratory Tract Infections within 14 days prior to Day -7
11. Respiratory Tract Infections requiring oral antibiotic within 14 days of Day -7
12. Asthma (with the exception of mild, intermittent asthma). Patients with mild, intermittent asthma who only require short-acting inhaled bronchodilators are eligible for enrollment.
13. Significant pulmonary disease including COPD
14. Clinically significant arrhythmia or with symptomatic cardiac conditions
15. A known history of alcohol or drug abuse
16. Existence of any surgical or medical condition or physical or laboratory findings, which in the opinion of the investigator or sponsor's medical monitor, might significantly alter the absorption, distribution, metabolism, or excretion of study drug or that might significantly affect the patient's ability to complete this trial.
17. Clinically relevant abnormal physical findings within 1 week of randomization which, in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures
18. Participation in MedPointe Protocols MP433, MP434, MP435, or MP436.
19. Employees of the research center or private practice and their family members are excluded
20. Patients who received prohibited medications within specified timepoints in the protocol.

Primary outcomes:
measure: Change From Baseline in 12-hour Reflective Total Nasal Symptom Score(rTNSS)for the Entire 14-day Study Period Compared to Placebo
timeFrame: baseline and 14 days
Secondary outcomes:
measure: Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo
timeFrame: baseline and 14 Days
measure: Change From Baseline in the 12-hour Reflective Secondary Symptom Complex Score for the Entire 14-day Study Period Compared to Placebo
timeFrame: baseline and 14 days
measure: Change From Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Patients 18 Years of Age and Older
timeFrame: baseline and 14 days
measure: Change From Baseline on Direct Visual Nasal Exams
timeFrame: 14 days
Other outcomes:
Locations:
city: Oxford
country: United States
facility: Center of Research Excellence, LLC
state: Alabama
city: Encinitas
country: United States
facility: Clinical Research Center
state: California
city: Los Angeles
country: United States
facility: Allergy Research Foundation
state: California
city: Mission Viejo
country: United States
facility: Southern California Research
state: California
city: San Diego
country: United States
facility: Allergy Associates Medical Group Inc
state: California
city: Colorado Springs
country: United States
facility: Storms Clinical Research Institute
state: Colorado
city: Denver
country: United States
facility: Colorado Allergy and Asthma Centers
state: Colorado
city: Decatur
country: United States
facility: ENTA Allergy, Head and Neck Associates
state: Illinois
city: Normal
country: United States
facility: Sneeze, Wheeze and Itch Associates
state: Illinois
city: Louisville
country: United States
facility: Family Allergy and Asthma Reserach
state: Kentucky
city: North Dartmouth
country: United States
facility: Northeast Medical Research Associates
state: Massachusetts
city: Plymouth
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Lincoln
country: United States
facility: Allergy, Asthma and Immunology Associates
state: Nebraska
city: Ocean
country: United States
facility: Atlantic Research Center
state: New Jersey
city: Skillman
country: United States
facility: Princeton Center for Clinical Research
state: New Jersey
city: Warren
country: United States
facility: Research Asthma, Sinus and Allergy Centers
state: New Jersey
city: Rochester
country: United States
facility: AAIR Research Center
state: New York
city: Raleigh
country: United States
facility: North Carolina Clinical Research
state: North Carolina
city: Cincinnati
country: United States
facility: Bernstein Clinical Research Center
state: Ohio
city: Oklahoma City
country: United States
facility: Allergy, Asthma and Clinical Research Center
state: Oklahoma
city: Collegeville
country: United States
facility: Allergy and Consultants of NJ/PA
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allergy and Clinical Immunology Associates
state: Pennsylvania
city: Charleston
country: United States
facility: National Allergy, Asthma and Urticaria of Charleston
state: South Carolina
city: Knoxville
country: United States
facility: East Tennesse Center for Clinical Research
state: Tennessee
city: Austin
country: United States
facility: Allergy and Asthma Associates
state: Texas
city: New Braunfels
country: United States
facility: Central Texas Health Research
state: Texas
city: San Antonio
country: United States
facility: Biogenics Research Institute
state: Texas
city: San Antonio
country: United States
facility: Sylvana Research Associates
state: Texas
city: Waco
country: United States
facility: Allergy and Asthma Care
state: Texas
Study officials:
References: