Allergic RhinitisPhase 4NCT01430260
Omnaris Versus Levocetirizine Phase 4 Study
A Phase 4 study testing Ciclesonide, Levocetirizine and Ciclesonide & Levocetirizine in people with Allergic Rhinitis, run by Handok Inc. at 1 site in South Korea.
Trial summary
This i a comparison of the efficacy ciclesonide nasal spray and levocetirizine, alone and in combination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Ciclesonide, Levocetirizine and Ciclesonide & Levocetirizine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 349 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2011to Jul 2012
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Allergic rhinitis patients aged ≥ 18 years (with a history of AR of 1 years or longer)
- Moderate to severe patient according to ARIA guideline
- To have a demonstrated positive skin prick test or other serologic tests to at least 1 allergen.
- Subjects who complete the subject diary(S) at least 70%.
Who cannot join
- Nasal pathology, including nasal polyps, clinically relevant respiratory tract malformations, recent nasal biopsy (within 60 days), nasal trauma, nasal surgery, atrophic rhinitis, rhinitis medicamentosa (within 60 days), asthma requiring corticosteroid treatment
- Hypersensitivity to corticosteroid and/or hydroxyzine
- Hypersensitivity to galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption
- A history of respiratory tract infection or disorder within 2 weeks of the screening visit or had a respiratory tract infection during baseline
- Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of β-agonists
- Treated with systemic corticosteroids (within 8 weeks of study initiation) or topical corticosteroids (> 1% hydrocortisone, within 4 weeks of study initiation) or antibiotics (within 2 weeks of first visit)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Open, Randomized, Three-arm, Parallel-group, Phase IV Study to Compare the Efficacy of Ciclesonide Nasal Spray and Levocetirizine, Alone and in Combination for the Patient With Allergic Rhinitis
This i a comparison of the efficacy ciclesonide nasal spray and levocetirizine, alone and in combination.
Read the detailed description
randomized, open-label, three arm, parallel group, multi-center study
- Conditions
- Allergic Rhinitis
- Being tested
- Ciclesonide, Levocetirizine, Ciclesonide & Levocetirizine
- Keywords
- efficacy, ciclesonide, levocetirizine, allergic rhinitis
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiclesonideDrug
Also called Omnaris
200 ㎍ once daily
LevocetirizineDrug
Also called XYZAL
5mg once daily
Ciclesonide & LevocetirizineDrug
Also called Omnaris nasal spray, XYZAL
- Omnaris (ciclesonide) 200 ㎍ once daily
- Levocetirizine 5mg once daily
| Study group | Role | What they receive |
|---|---|---|
| ciclesonide nasal spray | Experimental | ciclesonide nasal spray, alone Receives: Drug: Ciclesonide |
| Levocetirizine | Active comparator | Levocetirizine, alone Receives: Drug: Levocetirizine |
| Ciclesonide nasal spray & Levocetirizine | Active comparator | Ciclesonide nasal spray \& Levocetirizine in combination Receives: Drug: Ciclesonide & Levocetirizine |
What is being measured
The primary outcome is the main question the study is designed to answer.
rTNSS
change from baseline in the average of AM and PM patient assessed reflective TNSS
Measured: 2 weeks
Secondary outcomes (4)
rTOSS
Reflective total ocular symptom sores
Measured: 2 weeks
TNSS
Patient assessed individual TNSS
Measured: 2 weeks
PANS
Physician-assessed overall nasal signs and symptoms severity (PANS)
Measured: 2 weeks
RQLQ
Rhinoconjunctivitis quality of life questionnaire (RQLQ)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 349 participants (actual)
Sponsor and investigators
- Lead sponsor
- Handok Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Takeda
- Responsible party
- Sponsor
- Investigators
- Moonhwa Park, Doctor, Study director, Handok Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01430260
- Sponsor's protocol ID
- HANDOK2010.07
- Status last verified
- Sep 2012
- First submitted
- 6 Sep 2011
- Last updated
- 6 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open, Randomized, Three-arm, Parallel-group, Phase IV Study to Compare the Efficacy of Ciclesonide Nasal Spray and Levocetirizine, Alone and in Combination for the Patient With Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT01430260
- Acronym / sponsor ID
- HANDOK2010.07
- Conditions
- Allergic Rhinitis
- Keywords
- efficacy, ciclesonide, levocetirizine, allergic rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 349 participants (actual)
- Lead sponsor
- Handok Inc.Industry (pharma, biotech, devices)
- Collaborators
- Takeda
- Study start
- Jan 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 8 Sep 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.
This i a comparison of the efficacy ciclesonide nasal spray and levocetirizine, alone and in combination.
Detailed description
randomized, open-label, three arm, parallel group, multi-center study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ciclesonide nasal spray | Experimental | Drug: Ciclesonideciclesonide nasal spray, alone |
| Levocetirizine | Active comparator | Drug: LevocetirizineLevocetirizine, alone |
| Ciclesonide nasal spray & Levocetirizine | Active comparator | Drug: Ciclesonide & LevocetirizineCiclesonide nasal spray \& Levocetirizine in combination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Allergic rhinitis patients aged ≥ 18 years (with a history of AR of 1 years or longer)
- Moderate to severe patient according to ARIA guideline
- To have a demonstrated positive skin prick test or other serologic tests to at least 1 allergen.
- Subjects who complete the subject diary(S) at least 70%.
Key exclusion criteria (6 listed)
- Nasal pathology, including nasal polyps, clinically relevant respiratory tract malformations, recent nasal biopsy (within 60 days), nasal trauma, nasal surgery, atrophic rhinitis, rhinitis medicamentosa (within 60 days), asthma requiring corticosteroid treatment
- Hypersensitivity to corticosteroid and/or hydroxyzine
- Hypersensitivity to galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption
- A history of respiratory tract infection or disorder within 2 weeks of the screening visit or had a respiratory tract infection during baseline
- Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of β-agonists
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 |
|---|---|---|
| CiclesonideAlso: Omnaris200 ㎍ once daily | Drug | ciclesonide nasal spray |
| LevocetirizineAlso: XYZAL5mg once daily | Drug | Levocetirizine |
| Ciclesonide & LevocetirizineAlso: Omnaris nasal spray, XYZAL* Omnaris (ciclesonide) 200 ㎍ once daily * Levocetirizine 5mg once daily | Drug | Ciclesonide nasal spray & Levocetirizine |
Primary outcome
rTNSS
Time frame: 2 weeks
change from baseline in the average of AM and PM patient assessed reflective TNSS
4 secondary outcomes
rTOSS
Time frame: 2 weeks
TNSS
Time frame: 2 weeks
PANS
Time frame: 2 weeks
RQLQ
Time frame: 2 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 6 Sep 2012.
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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.
Moonhwa Park, Doctor study director
Handok Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ciclesonide, Levocetirizine and Ciclesonide & Levocetirizine in people with Allergic Rhinitis, run by Handok Inc. 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 6 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 6 Sep 2012. 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 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?
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?
rTNSS (time frame: 2 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 6 Sep 2012.