Back to resultsStudy to Evaluate the Safety and Tolerability of a Nasal Spray in Patients With Chronic Allergic or Nonallergic Rhinitis
Primary Purpose
Chronic Allergic Rhinitis, Nonallergic Rhinitis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Astepro Nasal Spray (0.1% azelastine hydrochloride)
Astelin Nasal Spray (0.1% azelastine hydrochloride)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Allergic Rhinitis
Eligibility Criteria
Inclusion Criteria:
- Male and female patients 12 years of age and older with an established history (> 1 year) of rhinitis due to perennial allergies, non-allergic triggers or vasomotor rhinitis (VMR).
- Provide written informed consent/pediatric assent. If the patient is a minor, a parent or legal guardian must give written informed consent
- Willing and able to comply with the study requirements, including daily use of medication for a one year period, even if symptoms are not bothersome.
- 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
- Patients receiving immunotherapy (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)
Exclusion Criteria:
- The use of any investigational drug within 30 days prior to screening. No other 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 and not practicing a medically acceptable method of contraception. Female patients must practice an acceptable contraceptive technique for 30 days before randomization and agree to continue its use during treatment and for 30 days after the last dose of study drug. Oral, intrauterine, implantable, injectable contraceptives, or a double barrier form of contraception are acceptable and the medication including dose, device or method must have been stable for at least 30 days before the first dose of study drug.
- Nasal disease(s) likely to affect deposition of intranasal medication, such as sinusitis,rhinitis medicamentosa or clinically significant nasal polyposis or nasal structural abnormalities
- Patients with asthma (with the exception of mild, intermittent asthma) or other significant pulmonary disease such as Chronic Obstructive Pulmonary Disease
- Patients with a known history of alcohol or drug abuse
- Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor, might significantly alter the evaluation of study
- Clinically relevant abnormal history and/or physical findings which, in the opinion of the investigator or sponsor, would interfere with the objectives of the study or that may preclude compliance with the study procedures
- Study site staff, immediate relatives of study site staff, or other individuals who would have access to the clinical study protocol
Sites / Locations
- Meda Clinical Trials Contact Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Astepro Nasal Spray (0.1% azelastine hydrochloride)
Astelin Nasal Spray (0.1% azelastine hydrochloride)
Outcomes
Primary Outcome Measures
Number of Participants Reporting Adverse Events
An AE can be any unfavorable and unintended sign,symptom, or disease temporally associated with the use of this investigational product, whether or not considered related to the investigational product. An AE is any untoward medical occurrence in a subject which does not necessarily have a causal relationship with this treatment.
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Examination of head and neck(scale: 0, 1+=Mild, 2+=Moderate, 3++Severe) for mucosal edema, nasal discharge, mucosal erythema, mucosal bleeding, mucosal ulcerations, crusting of mucosa, conjunctiva, tympanic membranes, lymph nodes of head and neck. Direct visual nasal examination (scale: None, Grade 2, Grade 3, and Grade 4) for epistaxis,ulceration and pain.
Secondary Outcome Measures
Adult Mini-Rhinoconjuctivitis Quality of Life Questionnaire. Change From Baseline in RQLQ Score at Months 1,3,6,9 and 12/or Early Termination.
The RQLQ consists of 7 domains rated on a 7-point scale with 0 being not troubled by the allergy symptoms,and 6 being extremely troubled. Total possible RQLQ score is 42 at any given evaluation. Scale of how troubled is:0=Not,2=Somewhat,3=Moderate,4=Quite a bit,5=Very,6 Extremely. Only change from baseline to month 12 primary analysis is provided.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00783432
Brief Title
Study to Evaluate the Safety and Tolerability of a Nasal Spray in Patients With Chronic Allergic or Nonallergic Rhinitis
Official Title
Active-Controlled Trial of the Safety and Tolerability of a MP03-33 in Patients With Chronic Allergic or Nonallergic Rhinitis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Meda Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if Astepro Nasal Spray (0.1% azelastine hydrochloride) is as safe as Astelin Nasal Spray (0.1% azelastine hydrochloride)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Allergic Rhinitis, Nonallergic Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
862 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Astepro Nasal Spray (0.1% azelastine hydrochloride)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Astelin Nasal Spray (0.1% azelastine hydrochloride)
Intervention Type
Drug
Intervention Name(s)
Astepro Nasal Spray (0.1% azelastine hydrochloride)
Intervention Description
548 mcg (2 sprays per nostril) twice a day
Intervention Type
Drug
Intervention Name(s)
Astelin Nasal Spray (0.1% azelastine hydrochloride)
Intervention Description
548 mcg (2 sprays per nostril) twice a day
Primary Outcome Measure Information:
Title
Number of Participants Reporting Adverse Events
Description
An AE can be any unfavorable and unintended sign,symptom, or disease temporally associated with the use of this investigational product, whether or not considered related to the investigational product. An AE is any untoward medical occurrence in a subject which does not necessarily have a causal relationship with this treatment.
Time Frame
12 months
Title
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Description
Examination of head and neck(scale: 0, 1+=Mild, 2+=Moderate, 3++Severe) for mucosal edema, nasal discharge, mucosal erythema, mucosal bleeding, mucosal ulcerations, crusting of mucosa, conjunctiva, tympanic membranes, lymph nodes of head and neck. Direct visual nasal examination (scale: None, Grade 2, Grade 3, and Grade 4) for epistaxis,ulceration and pain.
Time Frame
baseline and 12 months/ET
Secondary Outcome Measure Information:
Title
Adult Mini-Rhinoconjuctivitis Quality of Life Questionnaire. Change From Baseline in RQLQ Score at Months 1,3,6,9 and 12/or Early Termination.
Description
The RQLQ consists of 7 domains rated on a 7-point scale with 0 being not troubled by the allergy symptoms,and 6 being extremely troubled. Total possible RQLQ score is 42 at any given evaluation. Scale of how troubled is:0=Not,2=Somewhat,3=Moderate,4=Quite a bit,5=Very,6 Extremely. Only change from baseline to month 12 primary analysis is provided.
Time Frame
baseline, months 1,3,6,9 and 12/or early termination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female patients 12 years of age and older with an established history (> 1 year) of rhinitis due to perennial allergies, non-allergic triggers or vasomotor rhinitis (VMR).
Provide written informed consent/pediatric assent. If the patient is a minor, a parent or legal guardian must give written informed consent
Willing and able to comply with the study requirements, including daily use of medication for a one year period, even if symptoms are not bothersome.
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
Patients receiving immunotherapy (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)
Exclusion Criteria:
The use of any investigational drug within 30 days prior to screening. No other 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 and not practicing a medically acceptable method of contraception. Female patients must practice an acceptable contraceptive technique for 30 days before randomization and agree to continue its use during treatment and for 30 days after the last dose of study drug. Oral, intrauterine, implantable, injectable contraceptives, or a double barrier form of contraception are acceptable and the medication including dose, device or method must have been stable for at least 30 days before the first dose of study drug.
Nasal disease(s) likely to affect deposition of intranasal medication, such as sinusitis,rhinitis medicamentosa or clinically significant nasal polyposis or nasal structural abnormalities
Patients with asthma (with the exception of mild, intermittent asthma) or other significant pulmonary disease such as Chronic Obstructive Pulmonary Disease
Patients with a known history of alcohol or drug abuse
Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor, might significantly alter the evaluation of study
Clinically relevant abnormal history and/or physical findings which, in the opinion of the investigator or sponsor, would interfere with the objectives of the study or that may preclude compliance with the study procedures
Study site staff, immediate relatives of study site staff, or other individuals who would have access to the clinical study protocol
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
Meda Clinical Trials Contact Center
City
Somerset
State/Province
New Jersey
ZIP/Postal Code
08873
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate the Safety and Tolerability of a Nasal Spray in Patients With Chronic Allergic or Nonallergic Rhinitis
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