A Study to Evaluate the Safety and Efficacy of Two Nasal Sprays to Treat Seasonal Allergies

NCT00720278 | Completed Phase 3 Results

• 1 other identifier: MP438
• Study Type: interventional
• Target: 526
• Locations: 1 country
• Sites: 29

Brief Summary

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

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in 12-hour Reflective Total Nasal Symptom Score(rTNSS)for the Entire 14-day Study Period Compared to Placebo

  rTNSS consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. (maximum 12 points per assessment.) Total possible score is 24 per day. Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as a covariate.

  baseline and 14 days

Secondary Outcomes (4)

• Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo

  baseline and 14 Days

• Change From Baseline in the 12-hour Reflective Secondary Symptom Complex Score for the Entire 14-day Study Period Compared to Placebo

  baseline and 14 days

• 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

  baseline and 14 days

• Change From Baseline on Direct Visual Nasal Exams

  14 days

Study Arms (3)

Placebo Nasal Spray

PLACEBO COMPARATOR

Placebo nasal spray

Drug: Placebo

Astepro 0.1%

EXPERIMENTAL

0.1% azelastine hydrochloride nasal spray

Drug: 0.1% azelastine hydrochloride 1096 mcg daily

Astepro 0.15%

EXPERIMENTAL

0.15% azelastine hydrochloride nasal spray

Drug: 0.15% azelastine hydrochloride 1644 mcg daily

Interventions

0.15% azelastine hydrochloride 1644 mcg daily DRUG

0.15% azelastine hydrochloride 1644 mcg daily

Also known as: Astepro 0.15%

Astepro 0.15%

0.1% azelastine hydrochloride 1096 mcg daily DRUG

0.1% azelastine hydrochloride 1096 mcg daily

Also known as: Astepro 0.1%

Astepro 0.1%

Placebo DRUG

0 mcg Placebo daily

Placebo Nasal Spray

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients 12 years of age and older
• Provide written informed consent/pediatric assent. If the patient is a minor, a parent or legal guardian must give written informed consent
• 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
• 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)
• Randomization Visit: An instantaneous TNSS of ≥ 8 before beginning the onset of action assessment on Day 1
• Must have taken at least 10 doses of study medication during the lead-in period
• Willing and able to comply with the study requirements
• At least a 2-year history of SAR
• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• Other nasal disease(s) likely such as sinusitis, rhinitis medicamentosa, clinically significant polyposis, or nasal structural abnormalities.
• Nasal surgery or sinus surgery within the previous year.
• Chronic sinusitis - more than 3 episodes per year
• Planned travel outside of the study area during the study period
• 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
• Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose (Splenda® brand sweetener)
• 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 oral antibiotic within 14 days of Day -7
• Asthma (with the exception of mild, intermittent asthma). Patients with mild, intermittent asthma who only require short-acting inhaled bronchodilators are eligible for enrollment.
• Significant pulmonary disease including COPD
• Clinically significant arrhythmia or with symptomatic cardiac conditions
• A known history of alcohol or drug abuse

Sponsors & Collaborators

• Meda Pharmaceuticals: lead

Study Sites (29)

Center of Research Excellence, LLC

Oxford, Alabama, 36203, United States

Location

Clinical Research Center

Encinitas, California, 92024, United States

Location

Allergy Research Foundation

Los Angeles, California, 90025, United States

Location

Southern California Research

Mission Viejo, California, 92691, United States

Location

Allergy Associates Medical Group Inc

San Diego, California, 92120, United States

Location

Storms Clinical Research Institute

Colorado Springs, Colorado, 80907, United States

Location

Colorado Allergy and Asthma Centers

Denver, Colorado, 80230, United States

Location

ENTA Allergy, Head and Neck Associates

Decatur, Illinois, 62526, United States

Location

Sneeze, Wheeze and Itch Associates

Normal, Illinois, 61761, United States

Location

Family Allergy and Asthma Reserach

Louisville, Kentucky, 40215, United States

Location

Northeast Medical Research Associates

North Dartmouth, Massachusetts, 02747, United States

Location

Clinical Research Institute

Plymouth, Minnesota, 55441, United States

Location

Allergy, Asthma and Immunology Associates

Lincoln, Nebraska, 68505, United States

Location

Atlantic Research Center

Ocean City, New Jersey, 07712, United States

Location

Princeton Center for Clinical Research

Skillman, New Jersey, 08558, United States

Location

Research Asthma, Sinus and Allergy Centers

Warren Township, New Jersey, 07059, United States

Location

AAIR Research Center

Rochester, New York, 14618, United States

Location

North Carolina Clinical Research

Raleigh, North Carolina, 27607, United States

Location

Bernstein Clinical Research Center

Cincinnati, Ohio, 45231, United States

Location

Allergy, Asthma and Clinical Research Center

Oklahoma City, Oklahoma, 73120, United States

Location

Allergy and Consultants of NJ/PA

Collegeville, Pennsylvania, 19426, United States

Location

Allergy and Clinical Immunology Associates

Pittsburgh, Pennsylvania, 15241, United States

Location

National Allergy, Asthma and Urticaria of Charleston

Charleston, South Carolina, 29407, United States

Location

East Tennesse Center for Clinical Research

Knoxville, Tennessee, 37909, United States

Location

Allergy and Asthma Associates

Austin, Texas, 78731, United States

Location

Central Texas Health Research

New Braunfels, Texas, 78130, United States

Location

Biogenics Research Institute

San Antonio, Texas, 78229, United States

Location

Sylvana Research Associates

San Antonio, Texas, 78229, United States

Location

Allergy and Asthma Care

Waco, Texas, 76708, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

azelastine

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: William Wheeler, PhD
• Organization: Meda Pharmaceuticals

WWheeler@medapharma.us

732-564-2393

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 21, 2008
• First Posted: July 22, 2008
• Study Start: August 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: November 1, 2007
• Last Updated: March 2, 2010
• Results First Posted: October 27, 2009

Record last verified: 2010-02

Locations

US (29)