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

Primary Purpose

Seasonal Allergic Rhinitis

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

MP29-02

azelastine Hcl

fluticasone propionate

placebo

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male and female subjects 12 years of age and older with a 2 year history of moderate to severe seasonal allergic rhinitis
Must be in generally good health
Must meet minimum symptom requirements, as specified in the protocol.
Must be willing and able to provide informed consent and to participate in all study procedures
Positive skin test to a prevalent Texas Mountain Cedar allergen

Exclusion Criteria:

On Focused Nasal Examination, the presence of any nasal mucosal erosion, nasal ulceration, or nasal septal perforation (Grade 1b - 4) at either the screening visit or randomization visit will disqualify the subject from the study.
Other nasal disease(s) likely to affect deposition of intranasal medication, 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 screening. No investigational products are permitted for use during the conduct of this study
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* see section 6.1.1
Respiratory Tract Infections within 14 days prior to Day screening
Respiratory Tract Infections requiring antibiotic treatment 14 days prior to screening
Asthma (with the exception of mild, intermittent asthma). Subjects with mild, intermittent asthma who only require short-acting inhaled bronchodilators (not more often than twice per week) and who do not have nocturnal awakening as a result of asthma are eligible for enrollment
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, which in the opinion of the investigator or sponsor's medical monitor, 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.
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

Sites / Locations

Allergy and Asthma Associates
Central Texas Research
Southwest Allergy and Asthma Center, P.A.
Sylvana Research Associates
Allergy, Asthma Research Center
Allergy and Asthma Care
Allergy and Asthma Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

MP29-02

azelastine Hcl 548 mcg

fluticasone propionate 200 mcg

placebo

Arm Description

azelastine HCl 548 mcg / fluticasone propionate 200 mcg nasal spray

azelastine Hcl 548 mcg nasal spray

fluticasone propionate 200 mcg nasal spray

placebo nasal spray

Outcomes

Primary Outcome Measures

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

change from baseline in the 12 hour reflective total nasal symptoms 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.

Secondary Outcome Measures

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

change from baseline in the 12 hour instantaneous total nasal symptoms 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.

Change From Baseline in Adult ( Greater Than 18 Years of Age) Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the End of 14 Days

Change from Baseline in adult ( greater than 18 years of age) Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the end of 14 days The measurement scale is 0 to 24. A reduction in symptom severity score is indicated by a negative value.

Full Information

NCT ID

NCT00660517

First Posted

April 14, 2008

Last Updated

July 23, 2012

Sponsor

Meda Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00660517

Brief Title

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

Official Title

Randomized, Double-Blind Trial of MP29-02 Nasal Spray Compared to Placebo, Astelin Nasal Spray, and Fluticasone Propionate Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

December 2007 (undefined)

Primary Completion Date

February 2008 (Actual)

Study Completion Date

April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Meda Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

This will be a Phase III, randomized, double-blind, parallel-group study in subjects with moderate-to-severe SAR. The study will be conducted at 8 investigational sites during the 2007-2008 Texas Mountain Cedar allergy season. After a 7-day 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), consisting of the sum of the scores of sneezing, nasal congestion, runny nose, and nasal itching. On Days -7 through 14, subjects will rate the TNSS symptoms, the TOSS symptoms of itchy eyes, watery eyes and eye redness, and the symptom of postnasal drip 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. The 12-hour reflective TNSS, the instantaneous TNSS, the 12-hour reflective score for postnasal drip, the 12-hour reflective TOSS, and the instantaneous TOSS will be calculated based on these scores. Additional secondary efficacy variables will include reflective and individual nasal and ocular symptom scores and change from Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). Subjects ≥ 18 years of age will complete the adult 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Seasonal Allergic Rhinitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

607 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MP29-02

Arm Type

Experimental

Arm Description

azelastine HCl 548 mcg / fluticasone propionate 200 mcg nasal spray

Arm Title

azelastine Hcl 548 mcg

Arm Type

Active Comparator

Arm Description

azelastine Hcl 548 mcg nasal spray

Arm Title

fluticasone propionate 200 mcg

Arm Type

Active Comparator

Arm Description

fluticasone propionate 200 mcg nasal spray

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

placebo nasal spray

Intervention Type

Drug

Intervention Name(s)

MP29-02

Intervention Description

azelastine HCl 548 mcg / fluticasone propionate 200 mcg nasal spray one spray per nostril twice a day

Intervention Type

Drug

Intervention Name(s)

azelastine Hcl

Other Intervention Name(s)

Astelin

Intervention Description

azelastine Hcl nasal spray one spray per nostril two times a day

Intervention Type

Drug

Intervention Name(s)

fluticasone propionate

Other Intervention Name(s)

generic Flonase

Intervention Description

fluticasone propionate 200 mcg nasal spray one spray per nostril two times a day

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

placebo nasal spray one spray per nostril two times a day

Primary Outcome Measure Information:

Title

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

Description

Time Frame

day 1 to day14

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

day 1 to day 14

Title

Change From Baseline in Adult ( Greater Than 18 Years of Age) Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the End of 14 Days

Description

Time Frame

day 1 to day 14

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female subjects 12 years of age and older with a 2 year history of moderate to severe seasonal allergic rhinitis Must be in generally good health Must meet minimum symptom requirements, as specified in the protocol. Must be willing and able to provide informed consent and to participate in all study procedures Positive skin test to a prevalent Texas Mountain Cedar allergen Exclusion Criteria: On Focused Nasal Examination, the presence of any nasal mucosal erosion, nasal ulceration, or nasal septal perforation (Grade 1b - 4) at either the screening visit or randomization visit will disqualify the subject from the study. Other nasal disease(s) likely to affect deposition of intranasal medication, 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 screening. No investigational products are permitted for use during the conduct of this study 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* see section 6.1.1 Respiratory Tract Infections within 14 days prior to Day screening Respiratory Tract Infections requiring antibiotic treatment 14 days prior to screening Asthma (with the exception of mild, intermittent asthma). Subjects with mild, intermittent asthma who only require short-acting inhaled bronchodilators (not more often than twice per week) and who do not have nocturnal awakening as a result of asthma are eligible for enrollment 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, which in the opinion of the investigator or sponsor's medical monitor, 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. 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lewis M Fredane, MD

Organizational Affiliation

Meda Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Allergy and Asthma Associates

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

Central Texas Research

City

New Braunfels

State/Province

Texas

ZIP/Postal Code

78130

Country

United States

Facility Name

Southwest Allergy and Asthma Center, P.A.

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Sylvana Research Associates

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Allergy, Asthma Research Center

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78258

Country

United States

Facility Name

Allergy and Asthma Care

City

Waco

State/Province

Texas

ZIP/Postal Code

76708

Country

United States

Facility Name

Allergy and Asthma Center

City

Waco

State/Province

Texas

ZIP/Postal Code

76712

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

20674829

Citation

Hampel FC, Ratner PH, Van Bavel J, Amar NJ, Daftary P, Wheeler W, Sacks H. Double-blind, placebo-controlled study of azelastine and fluticasone in a single nasal spray delivery device. Ann Allergy Asthma Immunol. 2010 Aug;105(2):168-73. doi: 10.1016/j.anai.2010.06.008.

Results Reference

derived

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

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