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

Seasonal Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00883168
• Other study ID #: MP4006
• Status: Completed
• Phase: Phase 3
• First received: April 16, 2009
• Last updated: June 17, 2013
• Start date: April 2009
• Est. completion date: July 2009

Study information

• Verified date: June 2013
• Source: Meda Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1791
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• Placebo
Placebo
• azelastineHcl
azelastine hydrochloride 548 mg
• fluticasone propionate
fluticasone propionate 200 mcg
• azelastine Hcl/fluticasone propionate
azelastine hydrochloride 548 mcg/fluticasone propionate 200 mcg

Locations

Country	Name	City	State
United States	Clinical Research Atlanta	Atlanta	Georgia
United States	Allergy and Asthma Associates	Austin	Texas
United States	Allergy and Asthma Center of Austin	Austin	Texas
United States	National Allergy, Asthma and Urticaria of Charleston	Charleston	South Carolina
United States	Bernstein Clinical Research Center	Cincinnati	Ohio
United States	Allergy and Consultants of NJ/PA	Collegeville	Pennsylvania
United States	Asthma and Allergy Associates	Colorado Springs	Colorado
United States	Storms Clinical Research Institute	Colorado Springs	Colorado
United States	AARA Research Center	Dallas	Texas
United States	Pharmaceutical Research & Consulting Inc	Dallas	Texas
United States	Colorado Allergy and Asthma Centers	Denver	Colorado
United States	Intermountain Clinical Research	Draper	Utah
United States	Western Sky Medical Research	El Paso	Texas
United States	Clinical Research Center	Encinitas	California
United States	AABI Associates Medical Group	Fountain Valley	California
United States	East Tennesse Center for Clinical Research	Knoxville	Tennessee
United States	Allergy & Asthma Care Center of So. Cal	Long Beach	California
United States	Allergy Research Foundation	Los Angeles	California
United States	Family Allergy and Asthma Reserach	Louisville	Kentucky
United States	Clinical Research Institute of Southern Oregon, PC	Medford	Oregon
United States	Clinical Reseacrh Institute	Minneapolis	Minnesota
United States	Southern California Research	Mission Viejo	California
United States	Central Texas Health Research	New Braunfels	Texas
United States	Sneeze, Wheeze and Itch Associates	Normal	Illinois
United States	Northeast Medical Research Associates	North Dartmouth	Massachusetts
United States	Atlantic Research Center	Ocean	New Jersey
United States	Allergy, Asthma and Clinical Research Center	Oklahoma City	Oklahoma
United States	Kansas City Allergy and Asthma	Overland Park	Kansas
United States	The Asthma and Allergy Center	Papillion	Nebraska
United States	Allergy and Clinical Immunology Associates	Pittsburgh	Pennsylvania
United States	North Carolina Clinical Research	Raleigh	North Carolina
United States	Allergy, Asthma Research Center	San Antonio	Texas
United States	Diagnostic Research Group	San Antonio	Texas
United States	Sylvana Research Associates	San Antonio	Texas
United States	Allergy and Asthma Medical Group and Research Center	San Diego	California
United States	Allergy Associates Medical Group Inc	San Diego	California
United States	Allergy, Asthma and Immunology Associates	Scottsdale	Arizona
United States	Asthma, Inc.	Seattle	Washington
United States	Princeton Center for Clinical Research	Skillman	New Jersey
United States	The Clinical Research Center	St. Louis	Missouri
United States	Bensch Research Associates	Stockton	California
United States	Allergy and Asthma Center	Waco	Texas
United States	Allergy Asthma Research Institute	Waco	Texas
United States	Allergy and Asthma Clinical Research, Inc.	Walnut Creek	California
United States	Research Asthma, Sinus and Allergy Centers	Warren	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Meda Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in 12 Hour Reflective Total Nasal Symptom Score (rTNSS)	change from baseline in 12-hour reflective total nasal symptom score (rTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.An greater negative value is suggestive of improvement.	day 1 to day 14	No
Secondary	Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)	change from baseline in 12-hour instantaneous total nasal symptom score (iTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.A greater negative score is suggestive of improved condition.	day 1 to day 14	No
Secondary	Change From Baseline in Adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)	adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scored at day 1(baseline) and at day 14.The scale is measured from a value of 0 to 24. A negative number corresponds to a change from baseline measurement. An increased negative number is suggestive of improvement.	day 1 to day 14	No