Rhinitis, Allergic, PerennialPhase 3NCT02182544
WAL801CL (Epinastine Hydrochloride) Dry Syrup in Paediatric Perennial Allergic Rhinitis
A Phase 3 study testing WAL801CL dry syrup and Ketotifen fumarate dry syrup in people with Rhinitis, Allergic, Perennial, run by Boehringer Ingelheim.
Trial summary
Study to investigate the efficacy of WAL801CL Dry Syrup in comparison with ketotifen fumarate on pediatric perennial allergic rhinitis and to evaluate the safety of WAL801CL Dry Syrup compared to ketotifen fumarate and to confirm the appropriateness of dosage of WAL801 Dry Syrup. Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Rhinitis, Allergic, Perennial
- What is being tested?
- WAL801CL dry syrup and Ketotifen fumarate dry syrup
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 151 participants
- Where
- No sites listed yet
- Study dates
- Jun 2001to Dec 2001
- 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 Up to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 15 years of age or younger
- Body weight of 14 kg or more
- Typical symptoms of perennial allergic rhinitis, and within 2 or higher score of serum specific immunoglobulin E (IgE) caused by house dust (HD) or mite in the data obtained with the past one year
- "Moderate" or "Severe" in the Allergic Rhinitis Severity Classification during the observation period
- The Patient Diary can be entered by the patient or parent
- Outpatients
Who cannot join
- Absolute necessity of treatment with a drug that may affect the evaluation of the effect of the investigational drug (e.g., anti-histamines, anti-allergics, steroid, vasopressors). Patients being treated with the following drugs, however, may be included
- Intal® Oral or Inhalation
- Any eye drops other than Zaditen® Eye Drop
- External preparations (liniment, poultice)
- Initiation of desensitisation therapy within the past 6 months
- Onset of acute upper respiratory inflammation during the observation period
Show all 14Show fewer
- Nasal disease, such as acute or chronic rhinitis, nasal polyp, hypertrophic rhinitis, septal deviation*, sinusitis*, and hypertrophied adenoid*, of such a degree that the disease affects evaluation of the effect of the test drug (*: X-ray examination will be conducted if necessary)
- That pollen (cider, ragweed, Japanese cypress, orchard grass, etc.) is a double antigen, and that the study will be conducted in the season of air-borne pollen, and symptoms may be exacerbated by pollen
- Present or past history of a convulsive disease, such as epilepsy (convulsion threshold values may be decreased by the comparator drug, ketotifen fumarate)
- Clinically significant abnormal changes in laboratory measurements, and thus judgement that the patient is ineligible for inclusion in this study; however, if the patient is judged as falling into Grade 2 or more according to the MHW (Ministry of health and welfare) Adverse Reaction Severity Classification Criteria, the patient will be excluded from the study
- Clinically significant renal, hepatic or cardiac disease, or other complications, and thus judgement that the patient is ineligible for inclusion in the study; however, if the patient is judged as falling into Grade 2 or more according to the MHW Adverse Reaction Severity Classification Criteria, the patient will be excluded from the study
- Past history of drug allergy
- 1 month, or 6 times as long as the half life of the investigational drug if it is over 1 month, will not have passed since participation in any other clinical trial study, at the time of the initiation of this study
- Judgement by the Principal Investigator or Investigator that the patient is ineligible for inclusion in this study
About this study
Official title: Phase III Double-blind Comparative Study of WAL801CL Dry Syrup in Paediatric Perennial Allergic Rhinitis
Study to investigate the efficacy of WAL801CL Dry Syrup in comparison with ketotifen fumarate on pediatric perennial allergic rhinitis and to evaluate the safety of WAL801CL Dry Syrup compared to ketotifen fumarate and to confirm the appropriateness of dosage of WAL801 Dry Syrup.
- Conditions
- Rhinitis, Allergic, Perennial
- Being tested
- WAL801CL dry syrup, Ketotifen fumarate dry syrup, Ketotifen fumarate dry syrup placebo, WAL 801 CL dry syrup placebo
- 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.
WAL801CL dry syrupDrug
Ketotifen fumarate dry syrupDrug
Ketotifen fumarate dry syrup placeboDrug
WAL 801 CL dry syrup placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| WAL801CL dry syrup + Placebo | Experimental | Not described Receives: Drug: WAL801CL dry syrup; Drug: Ketotifen fumarate dry syrup placebo |
| Ketotifen fumarate dry syrup + Placebo | Active comparator | Not described Receives: Drug: Ketotifen fumarate dry syrup; Drug: WAL 801 CL dry syrup placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total severity scores of nasal symptoms judged by the physician
Measured: 2 weeks of first administration of study drug
Secondary outcomes (7)
Severity score for each nasal symptom given by the physician
Measured: 2 weeks of first administration of study drug
Nasal symptom score in the diary
Measured: 2 weeks
Total scores for nasal symptoms in the diary
Measured: 2 weeks of first administration of study drug
Severity score for allergic rhinitis according to the Allergic Rhinitis Severity Classification
Measured: 2 weeks
Impression of the patient or the parent
Measured: week 2 after first administration of study drug
Occurrence of adverse events
Measured: up to 2 weeks after administration of study drug
Number of patients with abnormal changes from baseline in laboratory tests (hematology, biochemistry, urinalysis)
Measured: Baseline and week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startJun 2001
- Primary completionDec 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, Allergic, PerennialStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe 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
- Double blind
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02182544
- Sponsor's protocol ID
- 262.258
- Status last verified
- Jul 2014
- First submitted
- 2 Jul 2014
- Last updated
- 14 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Double-blind Comparative Study of WAL801CL Dry Syrup in Paediatric Perennial Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT02182544
- Acronym / sponsor ID
- 262.258
- Conditions
- Rhinitis, Allergic, Perennial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2001
- Primary completion
- Dec 2001 (actual)
- First posted
- 8 Jul 2014 (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.
Study to investigate the efficacy of WAL801CL Dry Syrup in comparison with ketotifen fumarate on pediatric perennial allergic rhinitis and to evaluate the safety of WAL801CL Dry Syrup compared to ketotifen fumarate and to confirm the appropriateness of dosage of WAL801 Dry Syrup.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WAL801CL dry syrup + Placebo | Experimental | Drug: WAL801CL dry syrup, Drug: Ketotifen fumarate dry syrup placebo |
| Ketotifen fumarate dry syrup + Placebo | Active comparator | Drug: Ketotifen fumarate dry syrup, Drug: WAL 801 CL dry syrup placebo |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 15 years of age or younger
- Body weight of 14 kg or more
- Typical symptoms of perennial allergic rhinitis, and within 2 or higher score of serum specific immunoglobulin E (IgE) caused by house dust (HD) or mite in the data obtained with the past one year
- "Moderate" or "Severe" in the Allergic Rhinitis Severity Classification during the observation period
- The Patient Diary can be entered by the patient or parent
Key exclusion criteria (14 listed)
- Absolute necessity of treatment with a drug that may affect the evaluation of the effect of the investigational drug (e.g., anti-histamines, anti-allergics, steroid, vasopressors). Patients being treated with the following drugs, however, may be included
- Initiation of desensitisation therapy within the past 6 months
- Onset of acute upper respiratory inflammation during the observation period
- Nasal disease, such as acute or chronic rhinitis, nasal polyp, hypertrophic rhinitis, septal deviation*, sinusitis*, and hypertrophied adenoid*, of such a degree that the disease affects evaluation of the effect of the test drug (*: X-ray examination will be conducted if necessary)
- That pollen (cider, ragweed, Japanese cypress, orchard grass, etc.) is a double antigen, and that the study will be conducted in the season of air-borne pollen, and symptoms may be exacerbated by pollen
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 |
|---|---|---|
| WAL801CL dry syrup | Drug | WAL801CL dry syrup + Placebo |
| Ketotifen fumarate dry syrup | Drug | Ketotifen fumarate dry syrup + Placebo |
| Ketotifen fumarate dry syrup placebo | Drug | WAL801CL dry syrup + Placebo |
| WAL 801 CL dry syrup placebo | Drug | Ketotifen fumarate dry syrup + Placebo |
Primary outcome
Total severity scores of nasal symptoms judged by the physician
Time frame: 2 weeks of first administration of study drug
7 secondary outcomes
Severity score for each nasal symptom given by the physician
Time frame: 2 weeks of first administration of study drug
Nasal symptom score in the diary
Time frame: 2 weeks
Total scores for nasal symptoms in the diary
Time frame: 2 weeks of first administration of study drug
Severity score for allergic rhinitis according to the Allergic Rhinitis Severity Classification
Time frame: 2 weeks
Impression of the patient or the parent
Time frame: week 2 after first administration of study drug
Occurrence of adverse events
Time frame: up to 2 weeks after administration of study drug
Number of patients with abnormal changes from baseline in laboratory tests (hematology, biochemistry, urinalysis)
Time frame: Baseline and week 2
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 14 Jul 2014.
- Related InfoLink provided by the sponsor.
Related trials for Rhinitis, Allergic, Perennial
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A Study to Visualize Multi-Symptom Allergy in Adults With Seasonal Allergic Rhinitis
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing WAL801CL dry syrup and Ketotifen fumarate dry syrup in people with Rhinitis, Allergic, Perennial, run by Boehringer Ingelheim.
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 14 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 14 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Total severity scores of nasal symptoms judged by the physician (time frame: 2 weeks of first administration of study drug). 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 14 Jul 2014.