Perennial Allergic RhinitisPhase 3NCT01640535
Efficacy and Safety of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride in Perennial Allergic Rhinitis (PAR) Patients
A Phase 3 study testing Montelukast + Levocetirizine, Levocetirizine and Montelukast in people with Perennial Allergic Rhinitis, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
The purpose of this study is to demonstrate that the efficacy of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride is superior to that of Levocetirizine and Montelukast monotherapies and to compare the safety and tolerability of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride to those… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Perennial Allergic Rhinitis
- What is being tested?
- Montelukast + Levocetirizine, Levocetirizine and Montelukast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 283 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2012to Feb 2013
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with at least 2 years history of PAR prior to the study
- Positive results of skin prick test
- Patients who provided a signed written informed consent form
- Patients who are able and willing to complete subject diaries
- Patients who agree to maintain consistency in their surroundings throughout the study period
- At Visit, 2 patients whose symptom scores recorded in the subject diary meet all of the followings during the last one week of baseline period A.Daily mean of 6 points or above for Daytime Nasal Symptom Score (maximum 12 points) B.Daily mean of 1.8 points or above for Daytime Nasal Obstruction Symptom Score (maximum 3 points)
Who cannot join
- Patients also with non-allergic rhinitis with different causes.
- Patients with severe asthma who meet the followings.
- Presence of nasal polyps or any clinically important nasal anomaly.
- History of acute • chronic sinusitis within 30 days of Visit 1
- History of intranasal / eye surgeries within 3 months of Visit 1
- Initiation of immunotherapy or dose modification within 1 month prior to Visit 1
Show all 9Show fewer
- Upper respiratory infections including cold and systemic infections within 3 weeks of Visit 1.
- Chronic use of tricyclic antidepressants, beta agonists, bronchodilators, etc. that may affect the efficacy of study drug
- At Visit 2, patients who recorded Daytime Nasal Symptom Scores for fewer than 4 days in the subject diary during the last one week of baseline period
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Soonchunhyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, 420-767
About this study
Official title: Efficacy and Safety of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride in Perennial Allergic Rhinitis (PAR) Patients : A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Clinical Trial
The purpose of this study is to demonstrate that the efficacy of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride is superior to that of Levocetirizine and Montelukast monotherapies and to compare the safety and tolerability of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride to those of Levocetirizine and Montelukast monotherapies in Perennial Allergic Rhinitis (PAR) patients.
Read the detailed description
randomized, double-blind, active-controlled, multicenter, phase 3 trial
- Conditions
- Perennial Allergic Rhinitis
- Being tested
- Montelukast + Levocetirizine, Levocetirizine, Montelukast
- Keywords
- PAR
- 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.
Montelukast + LevocetirizineDrug
Also called Singulair Tablet, Xyzal Tablet
Tablet, Montelukast sodium 10 mg + Levocetirizine dihydrochloride 5 mg, Once daily (before bedtime)
LevocetirizineDrug
Also called Xyzal Tablet
Tablet, Matching placebo of Montelukast sodium 10 mg + Levocetirizine dihydrochloride 5 mg, Once daily (before bedtime)
MontelukastDrug
Also called Singulair Tablet
Tablet, Montelukast sodium 10 mg + matching placebo of Levocetirizine dihydrochloride 5 mg, Once daily (before bedtime)
| Study group | Role | What they receive |
|---|---|---|
| Test arm | Experimental | Montelukast sodium 10 mg + Levocetirizine dihydrochloride 5 mg Receives: Drug: Montelukast + Levocetirizine |
| Comparator arm I | Active comparator | Matching placebo of Montelukast sodium 10mg + Levocetirizine dihydrochloride 5 mg Receives: Drug: Levocetirizine |
| Comparator arm II | Active comparator | Montelukast sodium 10mg + matching placebo of Levocetirizine dihydrochloride 5mg Receives: Drug: Montelukast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Daytime Nasal Symptom Score
Change in Mean Daytime Nasal Symptom Score from baseline at Weeks 3-4(2 weeks) of treatment
Measured: 4 weeks
Secondary outcomes (2)
Change in Mean Nighttime Nasal Symptom from baseline at Weeks 1-2 (2 weeks) and Weeks 3-4 (2 weeks) of treatment
Change in Mean Nighttime Nasal Symptom from baseline at Weeks 1-2 (2 weeks) and Weeks 3-4 (2 weeks) of treatment
Measured: 4 weeks
Mean Composite Symptom Score
Change in Mean Composite Symptom Score from baseline at Weeks 1-2 (2 weeks) and Weeks 3-4 (2 weeks) of treatment
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 posted13 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionFeb 2013
- Study completionFeb 2013
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.
- More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
- 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
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyungmi PARK, PhD, Study director, Hanmi Pharmaceutical Company Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640535
- Sponsor's protocol ID
- HM-MOLZ-301
- Status last verified
- Apr 2013
- First submitted
- 10 Jul 2012
- Last updated
- 8 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride in Perennial Allergic Rhinitis (PAR) Patients : A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Clinical Trial
- ClinicalTrials.gov ID
- NCT01640535
- Acronym / sponsor ID
- HM-MOLZ-301
- Conditions
- Perennial Allergic Rhinitis
- Keywords
- PAR
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 13 Jul 2012 (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 demonstrate that the efficacy of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride is superior to that of Levocetirizine and Montelukast monotherapies and to compare the safety and tolerability of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride to those of Levocetirizine and Montelukast monotherapies in Perennial Allergic Rhinitis (PAR) patients.
Detailed description
randomized, double-blind, active-controlled, multicenter, phase 3 trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test arm | Experimental | Drug: Montelukast + LevocetirizineMontelukast sodium 10 mg + Levocetirizine dihydrochloride 5 mg |
| Comparator arm I | Active comparator | Drug: LevocetirizineMatching placebo of Montelukast sodium 10mg + Levocetirizine dihydrochloride 5 mg |
| Comparator arm II | Active comparator | Drug: MontelukastMontelukast sodium 10mg + matching placebo of Levocetirizine dihydrochloride 5mg |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with at least 2 years history of PAR prior to the study
- Positive results of skin prick test
- Patients who provided a signed written informed consent form
- Patients who are able and willing to complete subject diaries
- Patients who agree to maintain consistency in their surroundings throughout the study period
Key exclusion criteria (9 listed)
- Patients also with non-allergic rhinitis with different causes.
- Patients with severe asthma who meet the followings.
- Presence of nasal polyps or any clinically important nasal anomaly.
- History of acute • chronic sinusitis within 30 days of Visit 1
- History of intranasal / eye surgeries within 3 months of Visit 1
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 |
|---|---|---|
| Montelukast + LevocetirizineAlso: Singulair Tablet, Xyzal TabletTablet, Montelukast sodium 10 mg + Levocetirizine dihydrochloride 5 mg, Once daily (before bedtime) | Drug | Test arm |
| LevocetirizineAlso: Xyzal TabletTablet, Matching placebo of Montelukast sodium 10 mg + Levocetirizine dihydrochloride 5 mg, Once daily (before bedtime) | Drug | Comparator arm I |
| MontelukastAlso: Singulair TabletTablet, Montelukast sodium 10 mg + matching placebo of Levocetirizine dihydrochloride 5 mg, Once daily (before bedtime) | Drug | Comparator arm II |
Primary outcome
Mean Daytime Nasal Symptom Score
Time frame: 4 weeks
Change in Mean Daytime Nasal Symptom Score from baseline at Weeks 3-4(2 weeks) of treatment
2 secondary outcomes
Change in Mean Nighttime Nasal Symptom from baseline at Weeks 1-2 (2 weeks) and Weeks 3-4 (2 weeks) of treatment
Time frame: 4 weeks
Mean Composite 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 8 Apr 2013.
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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.
Kyungmi PARK, PhD study director
Hanmi Pharmaceutical Company Limited
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 Montelukast + Levocetirizine, Levocetirizine and Montelukast in people with Perennial Allergic Rhinitis, run by Hanmi Pharmaceutical Company Limited 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 6 inclusion and 9 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 8 Apr 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?
Mean Daytime 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 8 Apr 2013.