Seasonal Allergic RhinitisPhase 2NCT06126952
Azelastine Allergen Chamber - Onset of Action Study
A Phase 2 study testing Treatment A: Azelastine hydrochloride 0.15% nasal spray (Azelair) in people with Seasonal Allergic Rhinitis, run by MEDA Pharma GmbH & Co. KG at 1 site in Canada.
Trial summary
This study is to assess the Onset of Action and Efficacy of azelastine hydrochloride 0.15% in treating the nasal symptoms of seasonal allergic rhinitis (SAR) induced by an allergen challenge in an Environmental Exposure Unit (EEU) followed by a single dose and a 3-day treatment at home. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Treatment A: Azelastine hydrochloride 0.15% nasal spray (Azelair)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteCanada
- Study dates
- 30 Oct 2023to 18 Mar 2024
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Main Inclusion Criteria:
- Male or female subjects (childbearing and non-childbearing potential, non-childbearing potential defined as females with no menstruation for at least 1 year at screening and documented FSH > 35 IU/L) aged 18 to 55 years (inclusive) at screening.
- History of SAR to ragweed pollen for at least the previous 2 ragweed pollen seasons.
- Positive skin prick test (SPT) response to ragweed pollen (allergen induced wheal diameter at least 3 mm larger than the negative control). A test performed at Cliantha Research in the previous 12 months may be used to qualify the subject.
Main Exclusion Criteria:
Safety Concerns:
- History of allergic reaction to azelastine hydrochloride, olopatadine hydrochloride, mometasone furoate, or one of the excipients / components of the study treatments
- History of anaphylaxis, cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, metabolic, psychiatric, neurological, or other disease at screening that may affect subject safety during the study or evaluation of the study endpoints at the discretion of the Investigator and/or designee.
- Subjects with a current diagnosis of asthma or subjects with measured forced expiratory volume in 1 second (FEV1) <75% of the predicted value using Global Lung Function Initiative set from 2012 for references.
- Pregnant, breast-feeding, or planning a pregnancy during the study and women of childbearing potential not using adequate contraception.
Lack of suitability for the study:
- Use of prohibited therapies as specified in the respective table of the protocol.
- Acute or chronic sinusitis or non-allergic rhinitis, at the discretion of the Investigator and/or designee.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Cross-over Clinical Trial to Assess Onset of Action and Efficacy of Azelastine Hydrochloride 0.15% Nasal Spray in the Treatment of Allergen-Induced Allergic Rhinitis Symptoms in an Environmental Exposure Unit in Comparison to Placebo and Mometasone Furoate/Olopatadine Hydrochloride Nasal Spray
This study is to assess the Onset of Action and Efficacy of azelastine hydrochloride 0.15% in treating the nasal symptoms of seasonal allergic rhinitis (SAR) induced by an allergen challenge in an Environmental Exposure Unit (EEU) followed by a single dose and a 3-day treatment at home.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Treatment A: Azelastine hydrochloride 0.15% nasal spray (Azelair), Treatment B: Placebo (Azelastine 0.15% vehicle) nasal spray, Treatment C: Ryaltris (Active Control) - mometasone furoate monohydrate and olopatadine hydrochloride nasal spray
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment A: Azelastine hydrochloride 0.15% nasal spray (Azelair)Drug
2 sprays per nostril of Azelastine 0.15% twice daily.
Total dose of active drug:
1644 mcg azelastine hydrochloride per day
Treatment B: Placebo (Azelastine 0.15% vehicle) nasal sprayDrug
2 sprays per nostril of Placebo twice daily.
Treatment C: Ryaltris (Active Control) - mometasone furoate monohydrate and olopatadine hydrochloride nasal sprayDrug
2 sprays per nostril of Ryaltris twice daily.
Total dose of active drug:
200 mcg mometasone furoate and 4800 mcg olopatadine per day
| Study group | Role | What they receive |
|---|---|---|
| Treatment A (Azelair)+Treatment B (Placebo)+Treatment C (Ryaltris), min. 14 days wash-out period | Experimental | Cross-over design Receives: Drug: Treatment A: Azelastine hydrochloride 0.15% nasal spray (Azelair); Drug: Treatment B: Placebo (Azelastine 0.15% vehicle) nasal spray; Drug: Treatment C: Ryaltris (Active Control) - mometasone furoate monohydrate and olopatadine hydrochloride nasal spray |
| Treatment B (Placebo)+Treatment C (Ryaltris)+Treatment A (Azelair), min. 14 days of wash-out period | Experimental | Cross-over design Receives: Drug: Treatment A: Azelastine hydrochloride 0.15% nasal spray (Azelair); Drug: Treatment B: Placebo (Azelastine 0.15% vehicle) nasal spray; Drug: Treatment C: Ryaltris (Active Control) - mometasone furoate monohydrate and olopatadine hydrochloride nasal spray |
| Treatment C (Ryaltris)+Treatment A (Azelair)+Treatment B (Placebo), min. 14 days of wash-out period | Experimental | Cross-over design Receives: Drug: Treatment A: Azelastine hydrochloride 0.15% nasal spray (Azelair); Drug: Treatment B: Placebo (Azelastine 0.15% vehicle) nasal spray; Drug: Treatment C: Ryaltris (Active Control) - mometasone furoate monohydrate and olopatadine hydrochloride nasal spray |
| Treatment A (Azelair)+Treatment C (Ryaltris)+Treatment B (Placebo), min. 14 days of wash-out period | Experimental | Cross-over design Receives: Drug: Treatment A: Azelastine hydrochloride 0.15% nasal spray (Azelair); Drug: Treatment B: Placebo (Azelastine 0.15% vehicle) nasal spray; Drug: Treatment C: Ryaltris (Active Control) - mometasone furoate monohydrate and olopatadine hydrochloride nasal spray |
| Treatment B (Placebo)+Treatment A (Azelair)+Treatment C (Ryaltris), min.14 days of wash-out period | Experimental | Cross-over design Receives: Drug: Treatment A: Azelastine hydrochloride 0.15% nasal spray (Azelair); Drug: Treatment B: Placebo (Azelastine 0.15% vehicle) nasal spray; Drug: Treatment C: Ryaltris (Active Control) - mometasone furoate monohydrate and olopatadine hydrochloride nasal spray |
| Treatment C (Ryaltris)+Treatment B (Placebo)+Treatment A (Azelair), min. 14 days of wash-out period | Experimental | Cross-over design Receives: Drug: Treatment A: Azelastine hydrochloride 0.15% nasal spray (Azelair); Drug: Treatment B: Placebo (Azelastine 0.15% vehicle) nasal spray; Drug: Treatment C: Ryaltris (Active Control) - mometasone furoate monohydrate and olopatadine hydrochloride nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in TNSS at each post-dose assessment time point (0 to 4 hours after a single dose).
Onset of action of azelastine hydrochloride 0.15% nasal spray (Azelastine 0.15%) in treating the nasal symptoms of seasonal allergic rhinitis (SAR) induced by an allergen challenge in an Environmental Exposure Unit (EEU), measured by a difference from placebo in the change from baseline in patient -assessed instantaneous Total nasal symptom score (TNSS).
FDA guideline defines onset of action as the first time point after initiation of treatment when the product demonstrated a greater change from baseline compared to placebo which proved durable.
The TNSS is comprised of 4 symptoms from the nose, each scored on a scale of 0 to 3 (0 = none and 3 = severe). The sum of the TNSS contributes to a score ranging from 0 - 12.
Measured: 0 to 4 hours post application
Secondary outcomes (12)
Changes from baseline in TNSS at each post-dose assessment time point (0 to 4 hours after a single dose) at Visits 3, 6, and 9.
Onset of action, measured by the differences of both active treatments versus placebo in the change from baseline in patient-assessed instantaneous total symptom scores following treatment.
FDA guideline defines onset of action as the first time point after initiation of treatment when the product demonstrated a greater change from baseline compared to placebo which proved durable.
The TNSS is comprised of 4 symptoms from the nose, each scored on a scale of 0 to 3 (0 = none and 3 = severe). The sum of the TNSS contributes to a score ranging from 0 - 12.
Measured: 0 to 4 hours post application
Changes from baseline in TOSS at each post-dose assessment time point (0 to 4 hours after a single dose) at Visits 3, 6, and 9.
Onset of action, measured by the differences of both active treatments versus placebo in the change from baseline in patient-assessed instantaneous total symptom scores following treatment.
FDA guideline defines onset of action as the first time point after initiation of treatment when the product demonstrated a greater change from baseline compared to placebo which proved durable.
The TOSS is comprised of 3 symptoms from the eyes, each scored on a scale of 0 to 3 (0 = none and 3 = severe). The sum of the TOSS contributes to a score ranging from 0 - 9.
Measured: 0 to 4 hours post application
Changes from baseline in T7SS at each post-dose assessment time point (0 to 4 hours after a single dose) at Visits 3, 6, and 9.
Onset of action, measured by the differences of both active treatments versus placebo in the change from baseline in patient-assessed instantaneous total symptom scores following treatment.
FDA guideline defines onset of action as the first time point after initiation of treatment when the product demonstrated a greater change from baseline compared to placebo which proved durable.
The total 7 symptoms score (T7SS) will be the combination of the TNSS and TOSS, for a combined maximum score of 21.
Measured: 0 to 4 hours post application
Change from baseline in individual symptom scores at each post-dose assessment time point (0 to 4 hours after a single dose) at Visits 3, 6, and 9.
Onset of action, measured by change from baseline in individual symptom scores at each post-dose assessment time point (0 to 4 hours after a single dose) at Visits 3, 6, and 9.
Each individual symptom is scored on a scale of 0 to 3 (0 = none and 3 = severe).
Secondary endpoint include pairwise treatment comparisons of both active treatments versus placebo.
Measured: 0 to 4 hours post application
Changes from baseline in TNSS for all assessment time-points together.
Overall Efficacy, measured by changes from baseline in TNSS for all assessments during 0-4 hours and for visits 3, 6 and 9 together.
The TNSS is comprised of 4 symptoms from the nose, each scored on a scale of 0 to 3 (0 = none and 3 = severe). The sum of the TNSS contributes to a score ranging from 0 - 12.
Measured: 0 to 4 hours post application
Changes from baseline in TOSS for all assessment time-points together.
Overall Efficacy, measured by changes from baseline in TOSS for all assessments during 0-4 hours and for visits 3, 6 and 9 together.
The TOSS is comprised of 3 symptoms from the eyes, each scored on a scale of 0 to 3 (0 = none and 3 = severe). The sum of the TOSS contributes to a score ranging from 0 - 9.
Measured: 0 to 4 hours post application
Changes from baseline in T7SS for all assessment time-points together.
Overall Efficacy, measured by changes from baseline in T7SS for all assessments during 0-4 hours and for visits 3, 6 and 9 together.
The total 7 symptoms score (T7SS) will be the combination of the TNSS and TOSS, for a combined maximum score of 21.
Measured: 0 to 4 hours post application
Change from baseline in individual symptom scores for all assessment time-points together.
Overall Efficacy, measured by change from baseline in individual symptom scores for all assessments during 0-4 hours and for visits 3, 6 and 9 together.
Each individual symptom is scored on a scale of 0 to 3 (0 = none and 3 = severe).
Measured: 0 to 4 hours post application
Changes from baseline in TNSS for all assessment time-points together.
Overall Efficacy, measured by changes from baseline in TNSS for all assessments during 0-4 hours and for visits 4, 7 and 10 together after 3-day treatment.
The TNSS is comprised of 4 symptoms from the nose, each scored on a scale of 0 to 3 (0 = none and 3 = severe). The sum of the TNSS contributes to a score ranging from 0 - 12.
Measured: 0-4 hours after 3-day treatment
Changes from baseline in TOSS for all assessment time-points together.
Overall Efficacy, measured by changes from baseline in TOSS for all assessments during 0-4 hours and for visits 4, 7 and 10 together after 3-day treatment.
The TOSS is comprised of 3 symptoms from the eyes, each scored on a scale of 0 to 3 (0 = none and 3 = severe). The sum of the TOSS contributes to a score ranging from 0 - 9.
Measured: 0-4 hours after 3-day treatment
Changes from baseline in T7SS for all assessment time-points together.
Overall Efficacy, measured by changes from baseline in T7SS for all assessments during 0-4 hours and for visits 4, 7 and 10 together after 3-day treatment.
The total 7 symptoms score (T7SS) will be the combination of the TNSS and TOSS, for a combined maximum score of 21.
Measured: 0-4 hours after 3-day treatment
Change from baseline in individual symptom scores for all assessment time-points together.
Overall Efficacy, measured by change from baseline in individual symptom scores for all assessments during 0-4 hours and for visits 4, 7 and 10 together after 3-day treatment.
Each individual symptom is scored on a scale of 0 to 3 (0 = none and 3 = severe).
Measured: 0-4 hours after 3-day treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start30 Oct 2023
- Primary completion23 Feb 2024
- Study completion18 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal 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
- Model description
- The study will be a single-center, randomized, placebo-controlled, double-blind trial with three periods and six sequences (cross-over design).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- MEDA Pharma GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patricia Couroux, Dr., Principal investigator, Cliantha Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126952
- Sponsor's protocol ID
- AZEL-NS-2001
- Other IDs
- C2D03217
- Status last verified
- Mar 2024
- First submitted
- 27 Oct 2023
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Cross-over Clinical Trial to Assess Onset of Action and Efficacy of Azelastine Hydrochloride 0.15% Nasal Spray in the Treatment of Allergen-Induced Allergic Rhinitis Symptoms in an Environmental Exposure Unit in Comparison to Placebo and Mometasone Furoate/Olopatadine Hydrochloride Nasal Spray
- ClinicalTrials.gov ID
- NCT06126952
- Acronym / sponsor ID
- AZEL-NS-2001
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- MEDA Pharma GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 18 Mar 2024 (actual)
- First posted
- 13 Nov 2023 (actual)
- 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 study is to assess the Onset of Action and Efficacy of azelastine hydrochloride 0.15% in treating the nasal symptoms of seasonal allergic rhinitis (SAR) induced by an allergen challenge in an Environmental Exposure Unit (EEU) followed by a single dose and a 3-day treatment at home.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- The study will be a single-center, randomized, placebo-controlled, double-blind trial with three periods and six sequences (cross-over design).
| Arm | Type | Receives |
|---|---|---|
| Treatment A (Azelair)+Treatment B (Placebo)+Treatment C (Ryaltris), min. 14 days wash-out period | Experimental | Drug: Treatment A: Azelastine hydrochloride 0.15% nasal spray (Azelair), Drug: Treatment B: Placebo (Azelastine 0.15% vehicle) nasal spray, Drug: Treatment C: Ryaltris (Active Control) - mometasone furoate monohydrate and olopatadine hydrochloride nasal sprayCross-over design |
| Treatment B (Placebo)+Treatment C (Ryaltris)+Treatment A (Azelair), min. 14 days of wash-out period | Experimental | Drug: Treatment A: Azelastine hydrochloride 0.15% nasal spray (Azelair), Drug: Treatment B: Placebo (Azelastine 0.15% vehicle) nasal spray, Drug: Treatment C: Ryaltris (Active Control) - mometasone furoate monohydrate and olopatadine hydrochloride nasal sprayCross-over design |
| Treatment C (Ryaltris)+Treatment A (Azelair)+Treatment B (Placebo), min. 14 days of wash-out period | Experimental | Drug: Treatment A: Azelastine hydrochloride 0.15% nasal spray (Azelair), Drug: Treatment B: Placebo (Azelastine 0.15% vehicle) nasal spray, Drug: Treatment C: Ryaltris (Active Control) - mometasone furoate monohydrate and olopatadine hydrochloride nasal sprayCross-over design |
| Treatment A (Azelair)+Treatment C (Ryaltris)+Treatment B (Placebo), min. 14 days of wash-out period | Experimental | Drug: Treatment A: Azelastine hydrochloride 0.15% nasal spray (Azelair), Drug: Treatment B: Placebo (Azelastine 0.15% vehicle) nasal spray, Drug: Treatment C: Ryaltris (Active Control) - mometasone furoate monohydrate and olopatadine hydrochloride nasal sprayCross-over design |
| Treatment B (Placebo)+Treatment A (Azelair)+Treatment C (Ryaltris), min.14 days of wash-out period | Experimental | Drug: Treatment A: Azelastine hydrochloride 0.15% nasal spray (Azelair), Drug: Treatment B: Placebo (Azelastine 0.15% vehicle) nasal spray, Drug: Treatment C: Ryaltris (Active Control) - mometasone furoate monohydrate and olopatadine hydrochloride nasal sprayCross-over design |
| Treatment C (Ryaltris)+Treatment B (Placebo)+Treatment A (Azelair), min. 14 days of wash-out period | Experimental | Drug: Treatment A: Azelastine hydrochloride 0.15% nasal spray (Azelair), Drug: Treatment B: Placebo (Azelastine 0.15% vehicle) nasal spray, Drug: Treatment C: Ryaltris (Active Control) - mometasone furoate monohydrate and olopatadine hydrochloride nasal sprayCross-over design |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| Treatment A: Azelastine hydrochloride 0.15% nasal spray (Azelair)2 sprays per nostril of Azelastine 0.15% twice daily. Total dose of active drug: 1644 mcg azelastine hydrochloride per day | Drug | Treatment A (Azelair)+Treatment B (Placebo)+Treatment C (Ryaltris), min. 14 days wash-out period, Treatment A (Azelair)+Treatment C (Ryaltris)+Treatment B (Placebo), min. 14 days of wash-out period, Treatment B (Placebo)+Treatment A (Azelair)+Treatment C (Ryaltris), min.14 days of wash-out period, Treatment B (Placebo)+Treatment C (Ryaltris)+Treatment A (Azelair), min. 14 days of wash-out period, Treatment C (Ryaltris)+Treatment A (Azelair)+Treatment B (Placebo), min. 14 days of wash-out period, Treatment C (Ryaltris)+Treatment B (Placebo)+Treatment A (Azelair), min. 14 days of wash-out period |
| Treatment B: Placebo (Azelastine 0.15% vehicle) nasal spray2 sprays per nostril of Placebo twice daily. | Drug | Treatment A (Azelair)+Treatment B (Placebo)+Treatment C (Ryaltris), min. 14 days wash-out period, Treatment A (Azelair)+Treatment C (Ryaltris)+Treatment B (Placebo), min. 14 days of wash-out period, Treatment B (Placebo)+Treatment A (Azelair)+Treatment C (Ryaltris), min.14 days of wash-out period, Treatment B (Placebo)+Treatment C (Ryaltris)+Treatment A (Azelair), min. 14 days of wash-out period, Treatment C (Ryaltris)+Treatment A (Azelair)+Treatment B (Placebo), min. 14 days of wash-out period, Treatment C (Ryaltris)+Treatment B (Placebo)+Treatment A (Azelair), min. 14 days of wash-out period |
| Treatment C: Ryaltris (Active Control) - mometasone furoate monohydrate and olopatadine hydrochloride nasal spray2 sprays per nostril of Ryaltris twice daily. Total dose of active drug: 200 mcg mometasone furoate and 4800 mcg olopatadine per day | Drug | Treatment A (Azelair)+Treatment B (Placebo)+Treatment C (Ryaltris), min. 14 days wash-out period, Treatment A (Azelair)+Treatment C (Ryaltris)+Treatment B (Placebo), min. 14 days of wash-out period, Treatment B (Placebo)+Treatment A (Azelair)+Treatment C (Ryaltris), min.14 days of wash-out period, Treatment B (Placebo)+Treatment C (Ryaltris)+Treatment A (Azelair), min. 14 days of wash-out period, Treatment C (Ryaltris)+Treatment A (Azelair)+Treatment B (Placebo), min. 14 days of wash-out period, Treatment C (Ryaltris)+Treatment B (Placebo)+Treatment A (Azelair), min. 14 days of wash-out period |
Primary outcome
Change from baseline in TNSS at each post-dose assessment time point (0 to 4 hours after a single dose).
Time frame: 0 to 4 hours post application
Onset of action of azelastine hydrochloride 0.15% nasal spray (Azelastine 0.15%) in treating the nasal symptoms of seasonal allergic rhinitis (SAR) induced by an allergen challenge in an Environmental Exposure Unit (EEU), measured by a difference from placebo in the change from baseline in patient -assessed instantaneous Total nasal symptom score (TNSS). FDA guideline defines onset of action as the first time point after initiation of treatment when the product demonstrated a greater change from baseline compared to placebo which proved durable. The TNSS is comprised of 4 symptoms from the nose, each scored on a scale of 0 to 3 (0 = none and 3 = severe). The sum of the TNSS contributes to a score ranging from 0 - 12.
12 secondary outcomes
Changes from baseline in TNSS at each post-dose assessment time point (0 to 4 hours after a single dose) at Visits 3, 6, and 9.
Time frame: 0 to 4 hours post application
Changes from baseline in TOSS at each post-dose assessment time point (0 to 4 hours after a single dose) at Visits 3, 6, and 9.
Time frame: 0 to 4 hours post application
Changes from baseline in T7SS at each post-dose assessment time point (0 to 4 hours after a single dose) at Visits 3, 6, and 9.
Time frame: 0 to 4 hours post application
Change from baseline in individual symptom scores at each post-dose assessment time point (0 to 4 hours after a single dose) at Visits 3, 6, and 9.
Time frame: 0 to 4 hours post application
Changes from baseline in TNSS for all assessment time-points together.
Time frame: 0 to 4 hours post application
Changes from baseline in TOSS for all assessment time-points together.
Time frame: 0 to 4 hours post application
Changes from baseline in T7SS for all assessment time-points together.
Time frame: 0 to 4 hours post application
Change from baseline in individual symptom scores for all assessment time-points together.
Time frame: 0 to 4 hours post application
Changes from baseline in TNSS for all assessment time-points together.
Time frame: 0-4 hours after 3-day treatment
Changes from baseline in TOSS for all assessment time-points together.
Time frame: 0-4 hours after 3-day treatment
Changes from baseline in T7SS for all assessment time-points together.
Time frame: 0-4 hours after 3-day treatment
Change from baseline in individual symptom scores for all assessment time-points together.
Time frame: 0-4 hours after 3-day treatment
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 20 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Patricia Couroux, Dr. principal investigator
Cliantha Research
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 Treatment A: Azelastine hydrochloride 0.15% nasal spray (Azelair) in people with Seasonal Allergic Rhinitis, run by MEDA Pharma GmbH & Co. KG at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 20 Mar 2024. 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 Canada. 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 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?
Change from baseline in TNSS at each post-dose assessment time point (0 to 4 hours after a single dose). (time frame: 0 to 4 hours post application). 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 20 Mar 2024.