Safety of Astepro 0.15% Nasal Spray and Astepro 0.1% Nasal Spray in Children Ages >6 Months to <6 Years With AR
Randomized Trial of the Safety of Astepro 0.15% Nasal Spray and Astepro 0.1% Nasal Spray in Children Ages >6 Months to <6 Years With Allergic Rhinitis
1 other identifier
interventional
191
1 country
14
Brief Summary
The purpose of this study is to compare the safety of 2 different doses of the investigational use of an allergy medication (Astepro Nasal Spray) in the treatment of allergic rhinitis (AR). This is an open-label study; that is, parent and child will know which group each is in.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2013
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 17, 2013
CompletedFirst Posted
Study publicly available on registry
June 19, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
June 29, 2015
CompletedJune 29, 2015
April 1, 2014
10 months
June 17, 2013
June 9, 2015
June 9, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Safety
The objective of this clinical trial is to evaluate the safety of Astepro 0.15% Nasal Spray and Astepro 0.1% Nasal Spray at a dosage of 1 spray per nostril twice daily in subjects ≥6months to \<6 years of age with allergic rhinitis. Safety will be assessed on the basis of reported adverse experiences, nasal examinations, laboratory evaluations, and vital signs assessments. Data for each age strata will be summarized separately as well as combined.
one month of treatment
Study Arms (2)
Astepro 0.15% Nasal Spray
ACTIVE COMPARATORNasal Spray at a dosage of 1 spray per nostril twice daily
Astepro 0.1% Nasal Spray
ACTIVE COMPARATORNasal Spray at a dosage of 1 spray per nostril twice daily
Interventions
nasal spray
nasal spray
Eligibility Criteria
You may qualify if:
- Male and female subjects \>6 months to \<6 years, inclusive at the screening visit
- A history of AR
- The parent must provide written informed consent and the child must provide assent, if possible
- Willing and able to comply with the study requirements
- May benefit from treatment with Astepro Nasal Spray, based on the Investigator's assessment (based on medical history, physical examination, etc.) of the subject's clinical condition, at both the Screening and Randomization Visits
- 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
- Subjects 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 do not preclude participation)
You may not qualify if:
- On nasal examination, subjects with superficial nasal mucosal erosion, moderate nasal mucosal erosion, nasal mucosal ulceration, nasal septum perforation
- Other nasal disease(s) likely to affect deposition of intranasal medication, such as acute sinusitis, rhinitis medicamentosa or clinically significant polyposis or nasal structural abnormalities
- Nasal surgery or sinus surgery within the previous year
- Chronic sinusitis
- 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
- Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose (Splenda® brand sweetener)
- Respiratory tract infections within two weeks prior to Visit 1.
- Subjects with significant pulmonary disease including asthma. Subjects with intermittent asthma who only require short-acting inhaled bronchodilators are eligible for enrollment. Asthma (with the exception of intermittent asthma). Subjects with 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
- Chronic obstructive sleep apnea syndrome (clinical diagnosis)
- Existence of any surgical or medical condition, 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 subject's ability to complete this trial
- Clinically relevant abnormal physical findings or laboratory results which, in the opinion of the investigator, would interfere with the objectives -- Family members of research center or private practice personnel who are directly involved in this study are excluded
- Members of the same family cannot enroll in the study at the same time.
- Subjects who have used medications or therapies that could interfere with safety evaluations (see Section 4.0)
- Any behavioral condition which could affect subject's ability to accurately report symptoms to the caregiver such as developmental delay, attention deficit disorder, and autism
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Meda Pharmaceuticalslead
- Novella Clinicalcollaborator
Study Sites (14)
Clinical Research Center of Alabama,LLC
Birmingham, Alabama, 35209, United States
Little Rock Allergy and Asthma Clinical research Center
Little Rock, Alaska, 72205, United States
West Coast Clinical Trials
Costa Mesa, California, 92626, United States
Southern California Research
Mission Viejo, California, 92691, United States
Storms Clinical Research Institute
Colorado Springs, Colorado, 80907, United States
Sneeze, Wheeze and Itch Associates
Normal, Illinois, 61761, United States
Allergy, Asthma & Clinical Research Center
Oklahoma City, Oklahoma, 73120, United States
National Allergy, Asthna & Urticaria Centers of Charleston Pa
Charleston, Pennsylvania, 29406, United States
Texas Allergy Research Center
Dallas, Texas, 75246, United States
Central Texas Health Research
New Braunfels, Texas, 78130, United States
Paul H Ratner,MD
San Antonio, Texas, 78229, United States
Live Oak Allergy and Asthma Clinic
San Antonio, Texas, 78233, United States
Allergy and Asthma Center
Waco, Texas, 76712, United States
Pediatric Allergy,Asthma and Immunology/Allergy& Asthma care of Waco
Waco, Texas, 76712, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr.Nancy Ruiz Chief Medical Officer
- Organization
- Meda Pharmaceutical
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2013
First Posted
June 19, 2013
Study Start
June 1, 2013
Primary Completion
April 1, 2014
Study Completion
August 1, 2014
Last Updated
June 29, 2015
Results First Posted
June 29, 2015
Record last verified: 2014-04