Allergic RhinitisPhase 3NCT00789152
The Effect of Desloratadine and Levocetirizine on Nasal Obstruction (Study P03609)
A Phase 3 study testing desloratadine and levocetirizine in people with Allergic Rhinitis, run by Organon and Co.
Trial summary
This was a study to measure the ability of desloratadine and levocetirizine to decrease nasal obstruction in subjects who had study-induced allergic rhinitis. Study participants had allergic rhinitis symptoms induced in a Vienna Challenge Chamber and then received desloratadine or levocetirizine for 8 days. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- desloratadine and levocetirizine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2003to 1 May 2004
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 to 45 years of age
- Were free of any clinically significant disease that would interfere with study evaluations.
- Demonstrated hypersensitivity to the grass allergen used in the chamber unless confirmed previously within 12 months.
- Hypersensitivity to the allergen was documented by a positive response to the skin prick test with a wheal diameter at least 3 mm larger than the diluent control and by a radioallergosorbent test (RAST) class of >=2 (rating scale 0 -6).
- Had a history of SAR for at least 2 years, as diagnosed by the investigator, another physician, or subject-provided history.
- Reported having shown therapeutic efficacy with previous use of an antihistamine (without a decongestant).
- At the screening allergen provocation, the subject had a nasal obstruction symptom severity score of at least moderate (>=2) and a decrease from baseline in nasal airflow (mL/sec) measured by rhinomanometry of >=30% within 2 hours of allergen exposure. Also, the subject had a nasal obstruction symptom severity score of none or mild (<=1) prior to exposure to allergen.
Who cannot join
- Women who were pregnant or nursing.
- Had a body mass index (BMI) >=30 kg/m^2.
- Had asthma; were being treated with inhaled or oral corticosteroids, chromones, theophylline, leukotriene inhibitors, or short-acting inhaled β2-agonists (except during or immediately after the allergen exposures); and could not go through the washout periods and the entire study without needing these medications.
- Developed wheezing or dyspnea during the screening allergen exposure.
- Had a respiratory infection during the 4 weeks prior to pre-dose evaluations.
- Had any clinically significant deviation from normal in the physical examination that, in the investigator's judgment, could interfere with the study evaluation or affect subject safety.
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- Had any history of or laboratory evidence of hepatic failure or renal failure with a glomerular filtration rate (GFR) known to be <30 mL/min.
- Had a known potential for hypersensitivity, allergic, or idiosyncratic reaction to the study drug or excipients.
- Had nasal structural abnormalities, including large nasal polyps and marked septum deviation, that significantly interfered with nasal airflow.
About this study
Official title: The Effects of Desloratadine and Levocetirizine on Nasal Obstruction in Subjects With Induced Allergic Rhinitis in the VCC Assessed Clinically and With Nasal Rhinomanometry and Nasal Flowmetry
This was a study to measure the ability of desloratadine and levocetirizine to decrease nasal obstruction in subjects who had study-induced allergic rhinitis. Study participants had allergic rhinitis symptoms induced in a Vienna Challenge Chamber and then received desloratadine or levocetirizine for 8 days. After at least a 10 to 35-day washout period (time when no drug is given), subjects received the opposite treatment for 8 days. Subjects had their total nasal symptom measured.on the 8th day of each treatment period.
- Conditions
- Allergic Rhinitis
- Being tested
- desloratadine, levocetirizine
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
desloratadineDrug
Also called Clarinex, SCH 034117
desloratadine 5 mg daily x 8 days
levocetirizineDrug
Also called XYZAL®
levocetirizine 5 mg daily x 8 days
| Study group | Role | What they receive |
|---|---|---|
| desloratadine followed by levocetirizine | Experimental | Subjects in this arm received desloratadine 5 mg daily for 8 days, followed by 10 day washout period, then followed by levocetirizine 5 mg daily for 8 days Receives: Drug: desloratadine; Drug: levocetirizine |
| levocetirizine followed by desloratadine | Experimental | Subjects in this arm received levocetirizine 5 mg daily for 8 days, followed by 10 day washout period, then followed by desloratadine 5 mg daily for 8 days Receives: Drug: desloratadine; Drug: levocetirizine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Nasal Symptom Score (TNSS) at the end of treatment phase compared to pre-exposure baseline scores
Measured: End of each treatment phase (8th day)
Secondary outcomes (2)
Nasal Peak Inspiratory Flow (NPIF), Nasal secretion weights, nasal airflow, individual nasal symptoms, TNSS, Total Non-Nasal Symptoms Severity Score (TNNSS), Total Symptom Score (TSS)
Measured: End of each treatment phase (8th day)
Safety
Measured: All study visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2008 (estimated)
- Study start1 Dec 2003
- Primary completion1 May 2004
- Study completion1 May 2004
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00789152
- Sponsor's protocol ID
- P03609
- Status last verified
- Feb 2022
- First submitted
- 30 Oct 2008
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Desloratadine and Levocetirizine on Nasal Obstruction in Subjects With Induced Allergic Rhinitis in the VCC Assessed Clinically and With Nasal Rhinomanometry and Nasal Flowmetry
- ClinicalTrials.gov ID
- NCT00789152
- Acronym / sponsor ID
- P03609
- Conditions
- Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2003 (actual)
- Primary completion
- 1 May 2004 (actual)
- Study completion
- 1 May 2004 (actual)
- First posted
- 11 Nov 2008 (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 was a study to measure the ability of desloratadine and levocetirizine to decrease nasal obstruction in subjects who had study-induced allergic rhinitis. Study participants had allergic rhinitis symptoms induced in a Vienna Challenge Chamber and then received desloratadine or levocetirizine for 8 days. After at least a 10 to 35-day washout period (time when no drug is given), subjects received the opposite treatment for 8 days. Subjects had their total nasal symptom measured.on the 8th day of each treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| desloratadine followed by levocetirizine | Experimental | Drug: desloratadine, Drug: levocetirizineSubjects in this arm received desloratadine 5 mg daily for 8 days, followed by 10 day washout period, then followed by levocetirizine 5 mg daily for 8 days |
| levocetirizine followed by desloratadine | Experimental | Drug: desloratadine, Drug: levocetirizineSubjects in this arm received levocetirizine 5 mg daily for 8 days, followed by 10 day washout period, then followed by desloratadine 5 mg daily for 8 days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18 to 45 years of age
- Were free of any clinically significant disease that would interfere with study evaluations.
- Demonstrated hypersensitivity to the grass allergen used in the chamber unless confirmed previously within 12 months.
- Hypersensitivity to the allergen was documented by a positive response to the skin prick test with a wheal diameter at least 3 mm larger than the diluent control and by a radioallergosorbent test (RAST) class of >=2 (rating scale 0 -6).
- Had a history of SAR for at least 2 years, as diagnosed by the investigator, another physician, or subject-provided history.
Key exclusion criteria (9 listed)
- Women who were pregnant or nursing.
- Had a body mass index (BMI) >=30 kg/m^2.
- Had asthma; were being treated with inhaled or oral corticosteroids, chromones, theophylline, leukotriene inhibitors, or short-acting inhaled β2-agonists (except during or immediately after the allergen exposures); and could not go through the washout periods and the entire study without needing these medications.
- Developed wheezing or dyspnea during the screening allergen exposure.
- Had a respiratory infection during the 4 weeks prior to pre-dose evaluations.
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 |
|---|---|---|
| desloratadineAlso: Clarinex, SCH 034117desloratadine 5 mg daily x 8 days | Drug | desloratadine followed by levocetirizine, levocetirizine followed by desloratadine |
| levocetirizineAlso: XYZAL®levocetirizine 5 mg daily x 8 days | Drug | desloratadine followed by levocetirizine, levocetirizine followed by desloratadine |
Primary outcome
Change in Total Nasal Symptom Score (TNSS) at the end of treatment phase compared to pre-exposure baseline scores
Time frame: End of each treatment phase (8th day)
2 secondary outcomes
Nasal Peak Inspiratory Flow (NPIF), Nasal secretion weights, nasal airflow, individual nasal symptoms, TNSS, Total Non-Nasal Symptoms Severity Score (TNNSS), Total Symptom Score (TSS)
Time frame: End of each treatment phase (8th day)
Safety
Time frame: All study visits
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 15 Aug 2024.
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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 desloratadine and levocetirizine in people with Allergic Rhinitis, run by Organon and Co.
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 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 15 Aug 2024. 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?
Change in Total Nasal Symptom Score (TNSS) at the end of treatment phase compared to pre-exposure baseline scores (time frame: End of each treatment phase (8th day)). 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 15 Aug 2024.