Seasonal Allergic RhinitisPhase 3NCT01915823
Safety and Efficacy Trial of Dymista Nasal Spray in Children Ages 4 to 11 With Seasonal Allergic Rhinitis (SAR)
A Phase 3 study testing azelastine hydrochloride and fluticasone propionate in people with Seasonal Allergic Rhinitis, run by Meda Pharmaceuticals at 31 sites in United States.
Trial summary
The purpose of this study is to determine if Dymista nasal spray is better and safer than placebo in treating children ages 4 to <12 years old who have seasonal allergic rhinitis. Read more about this study
- Who is it for?
- Ages 4 to 11 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- azelastine hydrochloride and fluticasone propionate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 348 participants
- Where
- 31 sitesUnited States
- Study dates
- Jul 2013to Feb 2014
- Phase
- Phase 3
- 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 4 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female subjects ages >4 years to <12 years of age, inclusive at the screening visit
- The parent/caregiver must provide written informed consent and the child must provide pediatric assent, if possible
- Willing and able to comply with the study requirements
- Have a history of seasonal allergic rhinitis (SAR) to pollen in the prevailing allergy season.
- The presence of immunoglobulin E (IgE)-mediated hypersensitivity to prevailing pollen, confirmed by a positive response to skin prick test. A histamine skin test must also be positive. A positive response for both the pollen skin test and the histamine skin test is defined as a wheal diameter of at least 4 mm larger than the negative saline control
- 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
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- On the first day of the placebo lead-in period (Visit 1) subjects must have a 12-hour reflective total nasal symptoms score (rTNSS )of ≥6 and a reflective congestion score of ≥2 to qualify for entry.
- At Visit 2:
- Have taken at least 6 doses of the placebo lead-in medication during the placebo lead-in period
- At Visit 2, to be eligible for entry into the double-blind treatment period, subjects must have the total of the seven lead-in symptom assessments during the past 3 days of the lead-in period including the Day of Randomization (Visit 2, Day 1):
- a 12-hour reflective TNSS ≥ 42
- a 12-hour reflective congestion score of ≥14
Who cannot join
- On nasal examination, the presence of any superficial or moderate nasal mucosal erosion, nasal mucosal ulceration, or nasal septum perforation (Grade 1B - 4) at either the screening visit or randomization visit
- Nasal disease(s) likely to affect deposition of intranasal medication, such as acute or chronic sinusitis, rhinitis medicamentosa, clinically significant polyposis, or clinically significant nasal structural abnormalities.
- Nasal surgery or sinus surgery within the previous year.
- The use of any investigational drug within 30 days prior to signing the informed consent/pediatric assent at Visit 1. No investigational products are permitted for use during the conduct of this study
- Presence of any hypersensitivity to azelastine hydrochloride and/or fluticasone propionate or drugs similar to azelastine hydrochloride and/or fluticasone propionate
- Respiratory tract infections within 14 days prior to Visit1
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- Significant pulmonary disease including 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 that might significantly affect the subject's ability to complete this trial
- Clinically relevant abnormal physical findings which, in the opinion of the investigator or sponsor's medical monitor, would interfere with the objectives of the study or that may preclude compliance with the study procedures
- Family members of the research center or private practice personnel who are directly involved in this study are excluded
- Members of the same household cannot be enrolled at the same time
- Subjects who have used medications or therapies that could interfere with safety and efficacy evaluations and have not had the proper washouts from these medications or therapies
- 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
- Positive pregnancy test in female subjects ≥ 9 years of age
- Females who are pregnant or nursing
- Females of childbearing potential who are not abstinent and not practicing a medically acceptable method of contraception
- Subjects who fail to complete the symptom diary during the lead-in period, defined as missing data for >50% of entries
- 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 regimens following a brief period of missed injections do not preclude participation). Dose reduction when a new bottle is used does not preclude participation.
- Planned travel outside of the pollen area during the study period
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Clinical Research Atlanta
Atlanta, Georgia, 30342
Isis Clinical Research, LLC
Ausitn, Texas, 78731
Sirius Clinical Research
Austin, Texas, 78759
Clinical Research Center of Alabama,LLC
Birmingham, Alabama, 35209
Allergy and Asthma Specialist PC
Blue Bell, Pennsylvania, 19422
National Allergy, Asthma and Urticaria of Charleston
Charleston, South Carolina, 29407
Allergy and Asthma Consultants, LLP
Charleston, South Carolina, 29414
Bernstein Clinical Research Center
Cincinnati, Ohio, 45231
Clinical Research Institute of Indiana
Indianapolis, Indiana, 46208
Little Rock Allergy and Asthma Clinical research Center
Little Rock, Alaska, 72205
Family Allergy and Asthma Reserach
Louisville, Kentucky, 40215
Allergy and Asthma Research NJ inc
Mount Laurel, New Jersey, 08054
Central Texas Health Research
New Braunfels, Texas, 78130
Sneeze, Wheeze and Itch Associates
Normal, Illinois, 61761
Atlantic Research Center
Ocean City, New Jersey, 07712
Allergy, Asthma & Clinical Research Center
Oklahoma City, Oklahoma, 73120
Oklahoma Institute of Allergy and Asthma
Oklahoma City, Oklahoma, 73131
Clinical Research Institute
Plymouth, Minnesota, 55402
North Carolina Clinical Research
Raleigh, North Carolina, 27607
Sylvana Research Associates
San Antonio, Texas, 78229
Live Oak Allergy and Asthma Clinic
San Antonio, Texas, 78233
Aeroallergy Research Laboratories of Savannah
Savannah, Georgia, 31406
Princeton Center for Clinical Research
Skillman, New Jersey, 08558
The Clinical Research Center
St Louis, Missouri, 63141
Atlanta Allergy and Asthma Clinic
Stockbridge, Georgia, 30281
Asthma and Allergy Research Associate
Upland, Pennsylvania, 19013
Allergy Asthma Research Institute
Waco, Texas, 76712
Immunology/allergy and asthma Care of Waco
Waco, Texas, 76712
Clinical Research of the Ozarks,Inc
Warrensburg, Missouri, 64093
Institute for Asthma and Allergy PC
Wheaton, Maryland, 20902
Respiratory Medicine Research Institute of Michigan
Ypsilanti, Michigan, 48197
About this study
Official title: Randomized, Double-Blind Trial of the Safety and Efficacy of Dymista Nasal Spray Compared to Placebo Nasal Spray in the Treatment of Children Ages >4 Years to <12 Years With Seasonal Allergic Rhinitis
The purpose of this study is to determine if Dymista nasal spray is better and safer than placebo in treating children ages 4 to <12 years old who have seasonal allergic rhinitis.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- azelastine hydrochloride and fluticasone propionate, Dymista vehicle
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
azelastine hydrochloride and fluticasone propionateDrug
Also called Dymista
Dymista vehicleDrug
Also called placebo
| Study group | Role | What they receive |
|---|---|---|
| Dymista | Active comparator | (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg: Mode of Administration: Topical/intranasal spray
Dose: 548 mcg azelastine hydrochloride / 200 mcg fluticasone propionate, total daily dose Regimen: 1 spray per nostril twice daily Receives: Drug: azelastine hydrochloride and fluticasone propionate |
| Dymista vehicle | Placebo comparator | Dose: vehicle only Regimen: 1 spray per nostril twice daily Receives: Drug: Dymista vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy
change from baseline in AM+PM rTNSS (reflective total nasal symptoms score): ITT( intent to treat population)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 for the entire 14 day study period.The measurement scale is 0 to 24 so that the higher the number the worse the symptom.A reduction in symptom severity score is indicated by a negative value.A greater negative value suggests improvement.
Measured: 15 days of treatment
Secondary outcomes (1)
Safety
- Subject-reported adverse experiences (incidence, type, and severity of adverse events)
- Nasal Examinations
- Vital signs assessments
Measured: entire length of study (day 1 to day 22)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionFeb 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 Seasonal 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 348 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915823
- Sponsor's protocol ID
- MP 4008
- Status last verified
- Jun 2015
- First submitted
- 1 Aug 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, Double-Blind Trial of the Safety and Efficacy of Dymista Nasal Spray Compared to Placebo Nasal Spray in the Treatment of Children Ages >4 Years to <12 Years With Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT01915823
- Acronym / sponsor ID
- MP 4008
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- Meda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Feb 2014 (actual)
- First posted
- 5 Aug 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 determine if Dymista nasal spray is better and safer than placebo in treating children ages 4 to <12 years old who have seasonal allergic rhinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dymista | Active comparator | Drug: azelastine hydrochloride and fluticasone propionate(azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg: Mode of Administration: Topical/intranasal spray Dose: 548 mcg azelastine hydrochloride / 200 mcg fluticasone propionate, total daily dose Regimen: 1 spray per nostril twice daily |
| Dymista vehicle | Placebo comparator | Drug: Dymista vehicleDose: vehicle only Regimen: 1 spray per nostril twice daily |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Male and female subjects ages >4 years to <12 years of age, inclusive at the screening visit
- The parent/caregiver must provide written informed consent and the child must provide pediatric assent, if possible
- Willing and able to comply with the study requirements
- Have a history of seasonal allergic rhinitis (SAR) to pollen in the prevailing allergy season.
- The presence of immunoglobulin E (IgE)-mediated hypersensitivity to prevailing pollen, confirmed by a positive response to skin prick test. A histamine skin test must also be positive. A positive response for both the pollen skin test and the histamine skin test is defined as a wheal diameter of at least 4 mm larger than the negative saline control
Key exclusion criteria (20 listed)
- On nasal examination, the presence of any superficial or moderate nasal mucosal erosion, nasal mucosal ulceration, or nasal septum perforation (Grade 1B - 4) at either the screening visit or randomization visit
- Nasal disease(s) likely to affect deposition of intranasal medication, such as acute or chronic sinusitis, rhinitis medicamentosa, clinically significant polyposis, or clinically significant nasal structural abnormalities.
- Nasal surgery or sinus surgery within the previous year.
- The use of any investigational drug within 30 days prior to signing the informed consent/pediatric assent at Visit 1. No investigational products are permitted for use during the conduct of this study
- Presence of any hypersensitivity to azelastine hydrochloride and/or fluticasone propionate or drugs similar to azelastine hydrochloride and/or fluticasone propionate
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 |
|---|---|---|
| azelastine hydrochloride and fluticasone propionateAlso: Dymista | Drug | Dymista |
| Dymista vehicleAlso: placebo | Drug | Dymista vehicle |
Primary outcome
Primary Efficacy
Time frame: 15 days of treatment
change from baseline in AM+PM rTNSS (reflective total nasal symptoms score): ITT( intent to treat population)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 for the entire 14 day study period.The measurement scale is 0 to 24 so that the higher the number the worse the symptom.A reduction in symptom severity score is indicated by a negative value.A greater negative value suggests improvement.
1 secondary outcome
Safety
Time frame: entire length of study (day 1 to day 22)
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.
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing azelastine hydrochloride and fluticasone propionate in people with Seasonal Allergic Rhinitis, run by Meda Pharmaceuticals at 31 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 12 inclusion and 20 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 31 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Primary Efficacy (time frame: 15 days 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.