Perennial Allergic RhinitisPhase 3NCT01470053
Efficacy and Safety of Mometasone Furoate Plus Azelastine HCl Combination Versus Mometasone Furoate Alone or Azelastine Alone in Patients With Perennial Allergic Rhinitis
A Phase 3 study testing mometasone furoate plus azelastine HCl, mometasone furoate and azelastine HCl in people with Perennial Allergic Rhinitis, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate of efficacy and safety of mometasone furoate plus azelastine HCl in patients with perennial allergic rhinitis. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Perennial Allergic Rhinitis
- What is being tested?
- mometasone furoate plus azelastine HCl, mometasone furoate and azelastine HCl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 347 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2011to Nov 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients over 12 years of age
- Medical history of perennial allergic rhinitis for at least two years
- Moderate ro severe nasal symptom (during placebo run-in period AM rTNSS or PM rTNSS≥8)
- Positive skin prick test result within the previous 12 months
Who cannot join
- patients with active asthma that required therapy with inhaled or oral corticosteroids or long-term β-agonist
- patients with severe rhinostenosis, severely deviated nasal septum or local infection on the nasal mucous membrane
- patients with herpes zoster, glaucoma or cataract
- patients with history of operation or damage on nasal cavity or ocular region
- patients with drug-induced rhinitis
- patients with history of respiratory infection which requires antibiotic therapy within the previous 14 days
Show all 11Show fewer
- Patients with lung disease including COPD
- Patients with history of immunotherapy or ongoing immunotherapy
- patients administered with super potent or potent corticosteroid
- patients administered with intra-muscular or intra-articular steroid within the previous 3 months
- patients administered with subcutaneous omalizumab within the previous 5 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-blind Phase Ⅲ Study of Mometasone Furoate/Azelastine Hydrochloride Combination Group and Mometasone Furoate and Azelastine Hydrochloride Group 4 Weeks After Treatment, Each Treatment Group Comparisons for Evaluation of Efficacy and Safety in Perennial Allergic Rhinitis Patient.
The purpose of this study is to evaluate of efficacy and safety of mometasone furoate plus azelastine HCl in patients with perennial allergic rhinitis.
- Conditions
- Perennial Allergic Rhinitis
- Being tested
- mometasone furoate plus azelastine HCl, mometasone furoate, azelastine HCl
- Keywords
- mometasone furoate, azelastine HCl, perennial allergic rhinitis
- Medical subject headings
- Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mometasone furoate plus azelastine HClDrug
Also called Nasaflex Nasal Spray
mometasone furoateDrug
Also called NASONEX NASAL SPRAY
azelastine HClDrug
Also called AZEPTIN NASAL
| Study group | Role | What they receive |
|---|---|---|
| mometasone furoate + azelastin HCl | Experimental | opaque suspension, four times each naris per day Receives: Drug: mometasone furoate plus azelastine HCl |
| mometasone furoate | Active comparator | opaque suspension, four times each naris per day Receives: Drug: mometasone furoate |
| azelastine HCl | Active comparator | lucidus colorless liquid, two times each naris per day Receives: Drug: azelastine HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in rTNSS(reflective Total Nasal Symptom Score)
Measured: 4 weeks
Secondary outcomes (5)
change from baseline in AM rTNSS(AM reflective Total Nasal Symptom Score)
Measured: 4 weeks
change from baseline in PM rTNSS(PM reflective Total Nasal Symptom Score)
Measured: 4 weeks
change from baseline in iTNSS(instantaneous Total Nasal Symptom Score)
Measured: 4 weeks
change from baseline in AM iTNSS(AM instantaneous Total Nasal Symptom Score)
Measured: 4 weeks
change from baseline in PM iTNSS(PM instantaneous Total Nasal Symptom Score)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2011
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perennial 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanlim Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yang Gi Min, M.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470053
- Sponsor's protocol ID
- HL_NSFX_301
- Status last verified
- Nov 2011
- First submitted
- 8 Nov 2011
- Last updated
- 27 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind Phase Ⅲ Study of Mometasone Furoate/Azelastine Hydrochloride Combination Group and Mometasone Furoate and Azelastine Hydrochloride Group 4 Weeks After Treatment, Each Treatment Group Comparisons for Evaluation of Efficacy and Safety in Perennial Allergic Rhinitis Patient.
- ClinicalTrials.gov ID
- NCT01470053
- Acronym / sponsor ID
- HL_NSFX_301
- Conditions
- Perennial Allergic Rhinitis
- Keywords
- mometasone furoate, azelastine HCl, perennial allergic rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- Hanlim Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 11 Nov 2011 (estimated)
- Results
- Not posted in the source record
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 evaluate of efficacy and safety of mometasone furoate plus azelastine HCl in patients with perennial allergic rhinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mometasone furoate + azelastin HCl | Experimental | Drug: mometasone furoate plus azelastine HClopaque suspension, four times each naris per day |
| mometasone furoate | Active comparator | Drug: mometasone furoateopaque suspension, four times each naris per day |
| azelastine HCl | Active comparator | Drug: azelastine HCllucidus colorless liquid, two times each naris per day |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients over 12 years of age
- Medical history of perennial allergic rhinitis for at least two years
- Moderate ro severe nasal symptom (during placebo run-in period AM rTNSS or PM rTNSS≥8)
- Positive skin prick test result within the previous 12 months
Key exclusion criteria (11 listed)
- patients with active asthma that required therapy with inhaled or oral corticosteroids or long-term β-agonist
- patients with severe rhinostenosis, severely deviated nasal septum or local infection on the nasal mucous membrane
- patients with herpes zoster, glaucoma or cataract
- patients with history of operation or damage on nasal cavity or ocular region
- patients with drug-induced rhinitis
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 |
|---|---|---|
| mometasone furoate plus azelastine HClAlso: Nasaflex Nasal Spray | Drug | mometasone furoate + azelastin HCl |
| mometasone furoateAlso: NASONEX NASAL SPRAY | Drug | mometasone furoate |
| azelastine HClAlso: AZEPTIN NASAL | Drug | azelastine HCl |
Primary outcome
change from baseline in rTNSS(reflective Total Nasal Symptom Score)
Time frame: 4 weeks
5 secondary outcomes
change from baseline in AM rTNSS(AM reflective Total Nasal Symptom Score)
Time frame: 4 weeks
change from baseline in PM rTNSS(PM reflective Total Nasal Symptom Score)
Time frame: 4 weeks
change from baseline in iTNSS(instantaneous Total Nasal Symptom Score)
Time frame: 4 weeks
change from baseline in AM iTNSS(AM instantaneous Total Nasal Symptom Score)
Time frame: 4 weeks
change from baseline in PM iTNSS(PM instantaneous Total Nasal Symptom Score)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2013.
Related trials for Perennial Allergic Rhinitis
Active, not recruitingPhase 3
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
Perennial Allergic Rhinitis (PAR)
Not yet recruitingPhase 2
Study of CM512 Injection in Patients With Perennial Allergic Rhinitis on Background Therapy
Perennial Allergic Rhinitis (PAR)
RecruitingObservational study
Identification of B Regulatory Cells by Flow Cytometry
Pollen Allergy, Venom Allergy
Not yet recruitingPhase 4
A Study to Visualize Multi-Symptom Allergy in Adults With Seasonal Allergic Rhinitis
Rhinitis Allergic, Rhinitis Seasonal
Active, not recruitingPhase 2
Dupilumab Effects Against Aeroallergen Challenge
Asthma, Allergic
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.
Yang Gi Min, M.D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing mometasone furoate plus azelastine HCl, mometasone furoate and azelastine HCl in people with Perennial Allergic Rhinitis, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.
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 4 inclusion and 11 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 27 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
change from baseline in rTNSS(reflective Total Nasal Symptom Score) (time frame: 4 weeks). 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 27 Aug 2013.