Allergic RhinitisPhase 3NCT01794741
3 Month Safety Study of Dymista Nasal Spray and Fluticasone Propionate in Children 4-11 Years of Age With Allergic Rhinitis
A Phase 3 study testing Dymista Nasal Spray and Fluticasone propionate nasal spray in people with Allergic Rhinitis, run by Meda Pharmaceuticals at 41 sites in United States.
Trial summary
This is a 3 month safety study of Dymista Nasal spray in children aged 4 to 11 years with allergic rhinitis Read more about this study
- Who is it for?
- Ages 4 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Dymista Nasal Spray and Fluticasone propionate nasal spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 405 participants
- Where
- 41 sitesUnited States
- Study dates
- Feb 2013to Nov 2013
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Male and female subjects ≥ 4 years to <12 years, inclusive at the screening visit
- A history of allergic rhinitis (AR)
- The parent/caregiver must provide written informed consent and the child must provide assent
- Willing and able to comply with the study requirements
- Require treatment with Dymista Nasal Spray, based on the Investigator's assessment (based on medical history, physical examination, etc.) of the subjects' 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
- 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 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 two weeks prior to Visit 1.
Show all 17Show fewer
- Subjects with 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 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 of the study or that may preclude compliance with the study procedures
- 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 Sections 4.0 and 5.0) 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 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
Trial locations and contacts
41 sites in 1 country.
41 sites in 1 country
United States41 sites
Clinical Research Center of Alabama,LLC
Birmingham, Alabama, 35209
Allergy and Asthma Specialist PC
Blue Bell, Pennsylvania, 19422
National Allergy, Asthna & Urticaria Centers of Charleston Pa
Charleston, Pennsylvania, 29406
Bernstein Clinical Research Center
Cincinnati, Ohio, 45231
Storms Clinical Research Institute
Colorado Springs, Colorado, 80907
West Coast Clinical Trials
Costa Mesa, California, 92626
AARA Research Center
Dallas, Texas, 75231
Texas Allergy Research Center
Dallas, Texas, 75246
Colorado Allergy and Asthma Centers, PC
Denver, Colorado, 80230
Idaho Allergy
Eagle, Idaho, 83616
ADAC Research, PA
Greenville, South Carolina, 29607
Clinical Research Institute of Indiana
Indianapolis, Indiana, 46208
Baker Allergy Asthma & Dermatology Ctr LLC
Lake Oswego, Oregon, 97035
Little Rock Allergy and Asthma Clinical research Center
Little Rock, Alaska, 72205
Allergy & Asthma Care Center of So. Cal
Long Beach, California, 90808
Family Allergy and Asthma Reserach
Louisville, Kentucky, 40215
Clinical Reseacrh Institute
Minneapolis, Minnesota, 55402
Southern California Research
Mission Viejo, California, 92691
Central Texas Health Research
New Braunfels, Texas, 78130
Sneeze, Wheeze and Itch Associates
Normal, Illinois, 61761
Allergy and Asthma Care of Florida
Ocala, Florida, 34471
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
Midwest Allergy and Asthma Clinic
Omaha, Nebraska, 68130
The Asthma and Allergy Center, PC
Papillion, Nebraska, 68046
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, 15241
Asthma and Allergy Associates, PC
Pueblo, Colorado, 81001
North Carolina Clinical Research
Raleigh, North Carolina, 27607
Paul H Ratner,MD
San Antonio, Texas, 78229
Live Oak Allergy and Asthma Clinic
San Antonio, Texas, 78233
Allergy Associates Medical Group Inc
San Diego, California, 92120
Allergy & Asthma Associates of Santa Clara Valley Research Cntr
San Jose, California, 95117
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
Pediatric Allergy,Asthma and Immunology/Allergy& Asthma care of Waco
Waco, Texas, 76712
Asthma, Sinus & Allergy Centers, LLC
Warren Township, New Jersey, 07059
Clinical Research of the Ozarks,Inc
Warrensburg, Missouri, 64093
Respiratory Medicine Research Institute of Michigan
Ypsilanti, Michigan, 48197
About this study
Official title: Randomized Trial of the Safety of Dymista Nasal Spray and Fluticasone Propionate Nasal Spray in Children Ages >4 Years to <12 Years With Allergic Rhinitis
This is a 3 month safety study of Dymista Nasal spray in children aged 4 to 11 years with allergic rhinitis
- Conditions
- Allergic Rhinitis
- Being tested
- Dymista Nasal Spray, Fluticasone propionate nasal spray
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dymista Nasal SprayDrug
Fluticasone propionate nasal sprayDrug
| Study group | Role | What they receive |
|---|---|---|
| Dymista nasal spray | Active comparator | azelastine 137mcg per spray/fluticasone propionate 50mcg per spray one spray per nostril twice a day for three months Receives: Drug: Dymista Nasal Spray |
| fluticasone propionate nasal spray | Active comparator | fluticasone propionate nasal spray 50mcg per spray per nostril twice a day Receives: Drug: Fluticasone propionate nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events Report
reports of treatment emergent adverse events
Measured: 3 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionNov 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nancy Ruiz, M.D., Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01794741
- Sponsor's protocol ID
- MP 4007
- Status last verified
- Mar 2015
- First submitted
- 15 Feb 2013
- Last updated
- 31 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Berger W, Sher E, Gawchik S, Fineman S. Safety of a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate in children: A randomized clinical trial. Allergy Asthma Proc. 2018 Mar 1;39(2):110-116. doi: 10.2500/aap.2018.39.4116.
PubMed 29490769
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of the Safety of Dymista Nasal Spray and Fluticasone Propionate Nasal Spray in Children Ages >4 Years to <12 Years With Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT01794741
- Acronym / sponsor ID
- MP 4007
- Conditions
- Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- Meda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Nov 2013 (actual)
- First posted
- 20 Feb 2013 (estimated)
- Results
- Posted 31 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 3 month safety study of Dymista Nasal spray in children aged 4 to 11 years with allergic rhinitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dymista nasal spray | Active comparator | Drug: Dymista Nasal Sprayazelastine 137mcg per spray/fluticasone propionate 50mcg per spray one spray per nostril twice a day for three months |
| fluticasone propionate nasal spray | Active comparator | Drug: Fluticasone propionate nasal sprayfluticasone propionate nasal spray 50mcg per spray per nostril twice a day |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Male and female subjects ≥ 4 years to <12 years, inclusive at the screening visit
- A history of allergic rhinitis (AR)
- The parent/caregiver must provide written informed consent and the child must provide assent
- Willing and able to comply with the study requirements
- Require treatment with Dymista Nasal Spray, based on the Investigator's assessment (based on medical history, physical examination, etc.) of the subjects' clinical condition, at both the Screening and Randomization Visits
Key exclusion criteria (17 listed)
- On nasal examination, subjects with superficial nasal mucosal erosion, moderate nasal mucosal erosion, nasal mucosal ulceration, nasal septum perforation
- 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 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 |
|---|---|---|
| Dymista Nasal Spray | Drug | Dymista nasal spray |
| Fluticasone propionate nasal spray | Drug | fluticasone propionate nasal spray |
Primary outcome
Adverse Events Report
Time frame: 3 months of treatment
reports of treatment emergent adverse events
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29490769Berger W, Sher E, Gawchik S, Fineman S. Safety of a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate in children: A randomized clinical trial. Allergy Asthma Proc. 2018 Mar 1;39(2):110-116. doi: 10.2500/aap.2018.39.4116.
Related trials for Allergic Rhinitis
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Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
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RecruitingPhase 3
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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.
Nancy Ruiz, M.D. study director
Sponsor GmbH
41 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 Dymista Nasal Spray and Fluticasone propionate nasal spray in people with Allergic Rhinitis, run by Meda Pharmaceuticals at 41 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 17 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 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 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 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 31 Mar 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?
Adverse Events Report (time frame: 3 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01794741, which also lists 1 linked publication.
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 31 Mar 2015.