Allergic RhinitisPhase 2NCT00533637
Taste and Local Tolerance Study of NLA Nasal Spray in Patients With Allergic Rhinitis
A Phase 2 study testing Cetirizine dihydrochloride (10 mg/ml) liposomal formulation and Cetirizine dihydrochloride (10 mg/ml) buffer solution in people with Allergic Rhinitis, run by Biolipox AB at 1 site in Sweden.
Trial summary
Evaluation of NLA Nasal Spray with regard to taste perversion and local tolerance Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Cetirizine dihydrochloride (10 mg/ml) liposomal formulation and Cetirizine dihydrochloride (10 mg/ml) buffer solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2007to Dec 2007
- Phase
- Phase 2
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 to 50 years of age (inclusive)
- Body Mass Index (BMI) between 18 and 28 kg/m2
- History of pollen-induced seasonal allergic rhinitis for at least two years and otherwise healthy
- Elevated specific IgE to at least one aero allergen or at least one positive skin pick test (SPT)
- Seasonal allergic rhinitis with symptoms provoked by the allergen with a corresponding elevated specific IgE or positive SPT
- Signed written Informed Consent
Who cannot join
- Perennial allergic rhinitis except for cat and/or dog sensitivity under the condition that these patients are not exposed to cats and dogs
- Soy bean allergy
- Peanut allergy
- Smoking during the last month before study inclusion
- Any upper respiratory tract infection during the period of 2 weeks before the start of the study
- Chronic medication
Show all 17Show fewer
- Any medication, including herbal medicines, during their last five half-lives (t½)
- Nasal anatomical deviations
- Extensive use of nasal sprays as judged by the Investigator
- Ongoing nasal symptoms as judged by the Investigator
- Known hypersensitivity to cetirizine
- Pregnant or breast-feeding women
- Fertile women not using reliable methods of contraception (i.e. IUD, barrier method, hormonal contraceptives, abstinence)
- Participation in any other investigational study in the last three months
- Inability to adhere to the study plan
- Previous inclusion in this study
- Blood donation during the last three months
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Otorhinolaryngology, Lund University Hospital
Lund, SE-221 85
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Cross-Over, Allergen Challenge Study to Evaluate Taste and Local Tolerance of NLA Nasal Spray in Patients With Allergic Rhinitis
Evaluation of NLA Nasal Spray with regard to taste perversion and local tolerance
Read the detailed description
Oral or intranasal antihistamines is the first line treatment for allergic rhinitis. Cetirizine is a second-generation selective antihistamine widely used in an oral formulation for the treatment of allergic rhinitis. Local administration of cetirizine has been shown to reduce symptoms after allergen challenge, and has the potential to shorten the time to onset and decrease systemic side effects. However, local irritation and nasal burning/pain has been reported after nasal administration. For the compliance of the patients taking a nasal spray, the taste and tolerance of the product is of particular importance. NLA Nasal Spray contains cetirizine in a liposomal formulation aiming to improve the tolerability. The present study aims to compare the NLA Nasal Spray with cetirizine in an aqueous formulation and placebo with regard to taste perversion and local tolerance. This will be investigated off-season in patients with seasonal allergic rhinitis after provocation with allergen.
- Conditions
- Allergic Rhinitis
- Being tested
- Cetirizine dihydrochloride (10 mg/ml) liposomal formulation, Cetirizine dihydrochloride (10 mg/ml) buffer solution, Placebo
- Keywords
- Allergic rhinitis, Nasal spray, Anti-histamine, Tolerability
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetirizine dihydrochloride (10 mg/ml) liposomal formulationDrug
2x110μL in each nostril twice daily for 7 days
Cetirizine dihydrochloride (10 mg/ml) buffer solutionDrug
2x110μL in each nostril, as a single dose
PlaceboDrug
Citrate buffer with preservatives
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | NLA Nasal Spray Receives: Drug: Cetirizine dihydrochloride (10 mg/ml) liposomal formulation |
| 2 | Active comparator | Not described Receives: Drug: Cetirizine dihydrochloride (10 mg/ml) buffer solution |
| 3 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Taste perversion scores
Measured: 7 days
Local tolerance scores
Measured: 7 days
Secondary outcomes (2)
Treatment efficacy
Measured: 1 days
Type and incidence of AEs
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2007 (estimated)
- Study startSep 2007
- Study completionDec 2007
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biolipox AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lennart Greiff, MD, PhD, Principal investigator, University of Lund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00533637
- Sponsor's protocol ID
- NLA-C004P
- Status last verified
- Sep 2007
- First submitted
- 20 Sep 2007
- Last updated
- 5 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Cross-Over, Allergen Challenge Study to Evaluate Taste and Local Tolerance of NLA Nasal Spray in Patients With Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT00533637
- Acronym / sponsor ID
- NLA-C004P
- Conditions
- Allergic Rhinitis
- Keywords
- Allergic rhinitis, Nasal spray, Anti-histamine, Tolerability
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Biolipox ABIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Study completion
- Dec 2007 (actual)
- First posted
- 21 Sep 2007 (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.
Evaluation of NLA Nasal Spray with regard to taste perversion and local tolerance
Detailed description
Oral or intranasal antihistamines is the first line treatment for allergic rhinitis. Cetirizine is a second-generation selective antihistamine widely used in an oral formulation for the treatment of allergic rhinitis. Local administration of cetirizine has been shown to reduce symptoms after allergen challenge, and has the potential to shorten the time to onset and decrease systemic side effects. However, local irritation and nasal burning/pain has been reported after nasal administration. For the compliance of the patients taking a nasal spray, the taste and tolerance of the product is of particular importance. NLA Nasal Spray contains cetirizine in a liposomal formulation aiming to improve the tolerability. The present study aims to compare the NLA Nasal Spray with cetirizine in an aqueous formulation and placebo with regard to taste perversion and local tolerance. This will be investigated off-season in patients with seasonal allergic rhinitis after provocation with allergen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Cetirizine dihydrochloride (10 mg/ml) liposomal formulationNLA Nasal Spray |
| 2 | Active comparator | Drug: Cetirizine dihydrochloride (10 mg/ml) buffer solution |
| 3 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18 to 50 years of age (inclusive)
- Body Mass Index (BMI) between 18 and 28 kg/m2
- History of pollen-induced seasonal allergic rhinitis for at least two years and otherwise healthy
- Elevated specific IgE to at least one aero allergen or at least one positive skin pick test (SPT)
- Seasonal allergic rhinitis with symptoms provoked by the allergen with a corresponding elevated specific IgE or positive SPT
Key exclusion criteria (17 listed)
- Perennial allergic rhinitis except for cat and/or dog sensitivity under the condition that these patients are not exposed to cats and dogs
- Soy bean allergy
- Peanut allergy
- Smoking during the last month before study inclusion
- Any upper respiratory tract infection during the period of 2 weeks before the start of the study
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 |
|---|---|---|
| Cetirizine dihydrochloride (10 mg/ml) liposomal formulation2x110μL in each nostril twice daily for 7 days | Drug | 1 |
| Cetirizine dihydrochloride (10 mg/ml) buffer solution2x110μL in each nostril, as a single dose | Drug | 2 |
| PlaceboCitrate buffer with preservatives | Drug | 3 |
Primary outcome
Taste perversion scores
Time frame: 7 days
Local tolerance scores
Time frame: 7 days
2 secondary outcomes
Treatment efficacy
Time frame: 1 days
Type and incidence of AEs
Time frame: 7 days
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 5 Mar 2008.
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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.
Lennart Greiff, MD, PhD principal investigator
University of Lund
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cetirizine dihydrochloride (10 mg/ml) liposomal formulation and Cetirizine dihydrochloride (10 mg/ml) buffer solution in people with Allergic Rhinitis, run by Biolipox AB at 1 site in Sweden.
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 17 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 5 Mar 2008. 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 Sweden. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Taste perversion scores (time frame: 7 days). The study lists 2 primary outcomes in all. 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 5 Mar 2008.