Allergic RhinitisPhase 4NCT01880840
Safety of Astepro 0.15% Nasal Spray and Astepro 0.1% Nasal Spray in Children Ages >6 Months to <6 Years With AR
A Phase 4 study testing 205.5 mcg of azelastine hydrochloride and 137 mcg of azelastine hydrochloride in people with Allergic Rhinitis, run by Meda Pharmaceuticals at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- 205.5 mcg of azelastine hydrochloride and 137 mcg of azelastine hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 191 participants
- Where
- 14 sitesUnited States
- Study dates
- Jun 2013to Aug 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Clinical Research Center of Alabama,LLC
Birmingham, Alabama, 35209
National Allergy, Asthna & Urticaria Centers of Charleston Pa
Charleston, Pennsylvania, 29406
Storms Clinical Research Institute
Colorado Springs, Colorado, 80907
West Coast Clinical Trials
Costa Mesa, California, 92626
Texas Allergy Research Center
Dallas, Texas, 75246
Little Rock Allergy and Asthma Clinical research Center
Little Rock, Alaska, 72205
Southern California Research
Mission Viejo, California, 92691
Central Texas Health Research
New Braunfels, Texas, 78130
Sneeze, Wheeze and Itch Associates
Normal, Illinois, 61761
Allergy, Asthma & Clinical Research Center
Oklahoma City, Oklahoma, 73120
Paul H Ratner,MD
San Antonio, Texas, 78229
Live Oak Allergy and Asthma Clinic
San Antonio, Texas, 78233
Allergy and Asthma Center
Waco, Texas, 76712
Pediatric Allergy,Asthma and Immunology/Allergy& Asthma care of Waco
Waco, Texas, 76712
About this study
Official title: 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
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.
Read the detailed description
Approximately 200 subjects, between the ages of ≥ 6 months to < 6 years of age who have a history of AR will participate in this study.
The study will be conducted at about 20 research centers in the United States. Each research center will enroll approximately 2 to 10 subjects.
The study will involve at least 4 office visits over at least a 4-week period. You will need to keep the appointments as scheduled by the study personnel.
Some medications or therapies could interfere with the safety evaluations conducted in this study. If your child is currently taking any of these medications or therapies, they will need to discontinue them in order to be eligible for this study. Your study doctor will discuss this with you along with information on how this could affect your child's health. If you and the study doctor decide this is appropriate, there is a specific time period that these will need to be discontinued before your child can proceed in study evaluation.
If your child is eligible for study participation, he/she will be randomly assigned (by chance, like the flip of a coin) to one of the following two study drug groups:
- Astepro (azelastine hydrochloride) 0.15% Nasal Spray, 822 mcg (total daily dose); OR
- Astepro (azelastine hydrochloride) 0.1% Nasal Spray, 548 mcg (total daily dose)
The following are being performed for the purposes of this study and are not considered standard care:
- Your child will be placed in one of the two study drug groups by chance.
- You will complete questionnaires about your child's allergy symptoms.
- You will complete diary cards each morning recording your child's allergy symptoms over the previous 24 hours.
- Your child will have his/her vital signs measured (blood pressure, pulse, temperature and breathing rate).
- You and your child will be asked questions regarding your child's use of any medication or supplements and how your child has felt since his/her last visit.
- Blood and urine samples will be collected to assess the safety of taking the study drug.
- Conditions
- Allergic Rhinitis
- Being tested
- 205.5 mcg of azelastine hydrochloride, 137 mcg of azelastine hydrochloride
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
205.5 mcg of azelastine hydrochlorideDrug
Also called astepro .15%
nasal spray
137 mcg of azelastine hydrochlorideDrug
Also called astepro .1%
nasal spray
| Study group | Role | What they receive |
|---|---|---|
| Astepro 0.15% Nasal Spray | Active comparator | Nasal Spray at a dosage of 1 spray per nostril twice daily Receives: Drug: 205.5 mcg of azelastine hydrochloride |
| Astepro 0.1% Nasal Spray | Active comparator | Nasal Spray at a dosage of 1 spray per nostril twice daily Receives: Drug: 137 mcg of azelastine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one month of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionApr 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novella Clinical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880840
- Sponsor's protocol ID
- MP 442
- Status last verified
- Apr 2014
- First submitted
- 17 Jun 2013
- Last updated
- 29 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01880840
- Acronym / sponsor ID
- MP 442
- Conditions
- Allergic Rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Meda PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Novella Clinical
- Study start
- Jun 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 19 Jun 2013 (estimated)
- Results
- Posted 29 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Approximately 200 subjects, between the ages of ≥ 6 months to < 6 years of age who have a history of AR will participate in this study.
The study will be conducted at about 20 research centers in the United States. Each research center will enroll approximately 2 to 10 subjects.
The study will involve at least 4 office visits over at least a 4-week period. You will need to keep the appointments as scheduled by the study personnel.
Some medications or therapies could interfere with the safety evaluations conducted in this study. If your child is currently taking any of these medications or therapies, they will need to discontinue them in order to be eligible for this study. Your study doctor will discuss this with you along with information on how this could affect your child's health. If you and the study doctor decide this is appropriate, there is a specific time period that these will need to be discontinued before your child can proceed in study evaluation.
If your child is eligible for study participation, he/she will be randomly assigned (by chance, like the flip of a coin) to one of the following two study drug groups:
- Astepro (azelastine hydrochloride) 0.15% Nasal Spray, 822 mcg (total daily dose); OR
- Astepro (azelastine hydrochloride) 0.1% Nasal Spray, 548 mcg (total daily dose)
The following are being performed for the purposes of this study and are not considered standard care:
- Your child will be placed in one of the two study drug groups by chance.
- You will complete questionnaires about your child's allergy symptoms.
- You will complete diary cards each morning recording your child's allergy symptoms over the previous 24 hours.
- Your child will have his/her vital signs measured (blood pressure, pulse, temperature and breathing rate).
- You and your child will be asked questions regarding your child's use of any medication or supplements and how your child has felt since his/her last visit.
- Blood and urine samples will be collected to assess the safety of taking the study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Astepro 0.15% Nasal Spray | Active comparator | Drug: 205.5 mcg of azelastine hydrochlorideNasal Spray at a dosage of 1 spray per nostril twice daily |
| Astepro 0.1% Nasal Spray | Active comparator | Drug: 137 mcg of azelastine hydrochlorideNasal Spray at a dosage of 1 spray per nostril twice daily |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 205.5 mcg of azelastine hydrochlorideAlso: astepro .15%nasal spray | Drug | Astepro 0.15% Nasal Spray |
| 137 mcg of azelastine hydrochlorideAlso: astepro .1%nasal spray | Drug | Astepro 0.1% Nasal Spray |
Primary outcome
Safety
Time frame: one month of treatment
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 205.5 mcg of azelastine hydrochloride and 137 mcg of azelastine hydrochloride in people with Allergic Rhinitis, run by Meda Pharmaceuticals at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: one month of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2015.