Seasonal Allergic RhinitisPhase 3NCT05311475
Prospective, Randomized, Multinational, Multicenter, Double-blind, Placebo and Active Controlled Trial in 4 Parallel-groups of Patients Suffering From Seasonal Allergic Rhinitis
A Phase 3 study testing Mometasone and Azelastine in people with Seasonal Allergic Rhinitis, run by Sandoz at 28 sites in 4 countries.
Trial summary
The trial will be conducted as a prospective, randomized, multinational, multicenter, double-blind, placebo and active controlled trial in 4 parallel-groups of patients suffering from seasonal allergic rhinitis. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Mometasone and Azelastine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 669 participants
- Where
- 28 sitesin 4 countries
- Study dates
- 4 Apr 2022to 20 Jun 2023
- 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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Only patients fulfilling all of the following criteria at screening Visit 1 should be included in the present trial:
- Male or non-pregnant, non-lactating female patient aged between 12 and 65 years (valid for Poland) OR between 18 and 65 years (valid for Bulgaria, Moldova and Germany) inclusive on the date of consent.
- Female patient of childbearing potential abstaining from sexual intercourse or using a reliable method of contraception (e.g., condom with spermicide, intra uterine device, oral, injected, transdermal or implanted hormonal contraceptives, or had in the past a female sterilization e.g. tubal ligation, hysterectomy, oophorectomy, salpingectomy) for 30 days before enrolment and agree to continue its use during the trial.
- A minimum of two seasons of previous history of at least moderate seasonal allergic rhinitis (SAR) to the pollen/allergens in season at the time the trial is being conducted.
- Patient must have the following SAR symptoms: (i) nasal congestion, and at least one of the following; (ii) rhinorrhea; (iii) nasal itching; or (iv) sneezing. Nasal congestion plus one other nasal symptom score both rated by the patient as at least moderate in severity (≥2 on a 0-3 scale) and Total Nasal Symptom Score (TNSS) ≥6.0 over the last 24 hours.
- Negative SARS-CoV-2 Rapid Antigen Test result at screening visit.
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- For adults (≥18 years): Informed consent to participate in the trial provided in written form; For adolescents (≥12 - <18 years): own patient informed consent/ assent to participate in the trial and the informed consent from all parent(s)/ legal guardian(s) provided in written form.
- Inclusion criteria at Visit 2 (selection for randomization):
- Only patients fulfilling at Visit 2 the following inclusion criteria will be randomized in the trial:
- Pollen-specific immunoglobulin E (sIgE) test ≥EAST class 3 (at least 3.5 kU/l).
- Negative serum (hCG) pregnancy test (for female patient only).
- Patient selected for randomization must have the following SAR symptoms over 3 days during the 3- to 5-day baseline period: (i) nasal congestion, and 1 or more of the following; (ii) rhinorrhea; (iii) nasal itching; or (iv) sneezing.
- The mean TNSS must be ≥6.0 over 3 days out of the last 3-5 days of the Placebo run-in period; additionally, the mean nasal congestion score and mean of 1 other nasal symptom score both must be ≥2 (on a 0-3 scale) over 3 days out of the last 3-5 days of the Placebo run-in period.
Who cannot join
- Patients presenting any of the following criteria will NOT be included in the trial:
- Simultaneous participation in other clinical trials.
- Use of any investigational drug within 30 days prior to enrolment (Visit 1).
- Clinically significant medical condition (such as cardiovascular, hepatic, neurological, hematological, renal, gastrointestinal, endocrine or other major systemic disease) that, in the judgement of the investigator, would interfere with the trial, require treatment, or make implementation of the protocol or interpretation of the trial results difficult.
- Any known hypersensitivity to azelastine or other antihistamines, mometasone or other steroids, or any of the components of the trial nasal sprays.
- Structural nasal abnormalities symptomatic enough to cause nasal obstruction, as judged by the investigator, or any recent nasal surgery or trauma that is not completely healed.
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- Any other nasal conditions, including infectious rhinitis, sinusitis, rhinitis medicamentosa, atrophic rhinitis, and perennial rhinitis (PAR) (coexisting PAR will be allowed if SAR shows clear exacerbations).
- History of upper respiratory tract or sinus infection that required antibiotic therapy with the last dose within 14 days prior to screening.
- Treatment for oral candidiasis within 30 days of starting the trial.
- Presence of untreated fungal, bacterial or viral systemic infection, or infection of the ear, nose, and throat or oral cavity of any character.
- Presence of ocular herpes simplex or cataracts, or a history of glaucoma.
- Vaccination within 14 days prior to screening visit.
- History of habitual abuse of nasal decongestants (rhinitis medicamentosa).
- History of non-response to intranasal steroids.
- History of non-response to antihistamines.
- Recent exposure or being at risk to chicken pox or measles exposure.
- The patient is receiving immunotherapy or has received immunotherapy in the last 24 months.
- Use of anti-immunoglobulin E antibodies within 6 months prior to screening visit.
- Use of any of the following drugs:
- Systemic corticosteroid therapy within 60 days prior to screening visit.
- Topical (intranasal, inhaled, ocular) corticosteroid therapy within 30 days prior to screening visit.
- Immunosuppressive drugs and immunomodulating drugs (e.g., omalizumab, mepolizumab or dupilumab) within 30 days prior to screening visit.
- Cromolyn sodium or nedocromil within 14 days prior to screening visit.
- Tricyclic antidepressants within 14 days prior to screening visit.
- Histamine H1 antagonists (any generation of antihistamines) i.e., loratadine, cetirizine, desloratadine, levocetirizine, fexofenadine, hydroxyzine, etc. within 14 days prior to screening visit.
- Leukotriene modifiers within 7 days prior to screening visit.
- Nasal or oral decongestants (including anticholinergic agents, oxymetazoline, ephedrine or pseudoephedrine, and other vasoconstrictors) and mucolytics (like guaifenesin), or other medications that could mask the symptoms of rhinitis, e.g., major tranquilizers, anti-epileptic agents, within 3 days prior to screening visit. This includes over-the-counter preparations for common cold or eye drops containing any of the above-mentioned agents.
- Nasal sprays or washes with any medication, including saline, within 24 hours prior to screening visit.
- Planned to travel outside of the geographical region (as judged by the investigator according to regional pollination calendar) for >3 consecutive days during the trial.
- Member of the investigational trial staff or a member of the family of the investigational trial staff.
- History of alcohol or drug abuse within the last 5 years.
- History of non-compliance with medication regimens or treatment protocols in previous clinical studies.
- Legal incapacity (for adults only) and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the trial.
- Patients who are known or suspected to be in custody or submitted to an institution due to a judicial order.
Trial locations and contacts
28 sites in 4 countries.
28 sites in 4 countries
Germany10 sites
Sandoz Investigative Site
Aachen
Sandoz Investigative Site
Dreieich
Sandoz Investigative Site
Dresden
Sandoz Investigative Site
Duisburg
Sandoz Investigative Site
Hamburg
Sandoz Investigative Site
Heidelberg
Sandoz Investigative Site
Neuenhagen
Sandoz Investigative Site
Röthenbach
Sandoz Investigative Site
Schorndorf
Sandoz Investigative Site
Viernheim
Poland10 sites
Sandoz Investigative Site
Brzeg Dolny
Sandoz Investigative Site
Chodzież
Sandoz Investigative Site
Inowrocław
Sandoz Investigative Site
Jaksice
Sandoz Investigative Site
Lodz
Sandoz Investigative Site
Lublin
Sandoz Investigative Site
Ostrowiec
Sandoz Investigative Site
Poznan
Sandoz Investigative Site
Warsaw
Sandoz Investigative Site
Wroclaw
Bulgaria7 sites
Sandoz Investigative Site
Burgas
Sandoz Investigative Site
Gabrovo
Sandoz Investigative Site
Plovdiv
Sandoz Investigative Site
Sliven
Sandoz Investigative Site
Sofia, 1606
Sandoz Investigative Site
Sofia
Sandoz Investigative Site
Varna
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo and Active Controlled Parallel-group Trial to Assess the Efficacy and Safety of the Fixed Combination Medicinal Product Mometasone Furoate + Azelastine Hydrochloride Nasal Spray (50 + 140 mcg) in the Treatment of Seasonal Allergic Rhinitis
The trial will be conducted as a prospective, randomized, multinational, multicenter, double-blind, placebo and active controlled trial in 4 parallel-groups of patients suffering from seasonal allergic rhinitis.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Mometasone, Azelastine, Placebo
- 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.
MometasoneDrug
Mometasone furoate nasal spray (50 mcg per actuation)
AzelastineDrug
Azelastine hydrochloride nasal spray (140 mcg per actuation)
PlaceboDrug
Placebo nasal spray
| Study group | Role | What they receive |
|---|---|---|
| Mometasone + Azelastine | Experimental | Mometasone + Azelastine (50 + 140 mcg per actuation) Receives: Drug: Mometasone; Drug: Azelastine |
| Mometasone | Active comparator | Mometasone furoate nasal spray (50 mcg per actuation) Receives: Drug: Mometasone |
| Azelastine | Active comparator | Azelastine hydrochloride nasal spray (140 mcg per actuation) Receives: Drug: Azelastine |
| Placebo | Placebo comparator | Placebo nasal spray Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the daily Total Nasal Symptom Score (TNSS)
The benefit of the treatment with the fixed combination medicinal product Momeatsone+Azelastine nasal spray (test product) in comparison to the treatment with the individual medicinal products Mometasone nasal spray and Azelastine nasal spray (comparator products) will be assessed by comparing the change from baseline in the daily Total Nasal Symptom Score (TNSS) during the first seven days of treatment. Total Nasal Symptom Score (TNSS) of 4 symptoms (rhinorrhea, sneezing, nasal itching, and nasal congestion) will be assessed by the patient in a patient's diary. Each symptom will be scored on a 4-point scale where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms, such that the maximum TNSS is 12.
Measured: Baseline, Day 7
Secondary outcomes (11)
Change from baseline in the daily Total Nasal Symptom Score (TNSS)
Total Nasal Symptom Score (TNSS) of 4 symptoms (rhinorrhea, sneezing, nasal itching, and nasal congestion) will be assessed by the patient in a patient's diary starting at Visit 1 for the baseline run-in period (3 to 5 days). The mean of the symptom scores during the last 3 days prior to Visit 2 will be used to calculate baseline symptoms. Following randomization at Visit 2, the patient will document the TNSS in the evening retrospectively for each day of treatment until treatment day 14. Each symptom will be scored on a 4-point scale where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms, such that the maximum TNSS is 12.
Measured: Baseline, Day 14
Change from baseline in individual daily nasal symptoms
Change from baseline in individual daily nasal symptoms (nasal congestion, rhinorrhea, nasal itching and sneezing) during 7 and 14 days of treatment for all four arms will be assessed.
Measured: Baseline, Day 7 and Day 14
Change from baseline in individual daily ocular symptoms
Ocular itching and Redness and Ocular tearing will be scored on a 4-point scale where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The symptoms will be assessed by the patient in a patient's diary starting at Visit 1. The patient will document the ocular symptoms in the evening retrospectively for each day of treatment until treatment day 14.
Measured: Baseline, Day 7 and Day 14
Baseline-adjusted differences in nasal obstruction assessed by peak nasal inspiratory flow measurements (PNIF)
The PNIF will be performed by means of portable In-Check Nasal flow meter using a face mask which the patient applies over the nose (without touching it) with the mouth closed. The In-Check Nasal is a portable inspiratory flow meter, measuring inspiratory flow between 30-370 L/min.
Measured: Baseline, Day 7 and Day 14
Change from baseline in Rhinoscopy score
Rhinoscopy score: during the nasal examination the investigator will evaluate the symptoms rhinorrhea, redness and edema using a 4-point scale as follows: absent = 0, mild = 1, moderate = 2, and severe = 3.
Measured: Baseline, Day 7 and Day 14
Intra-group changes in health-related Quality of Life (RQLQ)
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) has 28 questions in 7 domains (activity limitation, sleep problems, nose symptoms, eye symptoms, non-nose/eye symptoms, practical problems and emotional function). There are 3 'patient-specific' questions in the activity domain which allow patients to select 3 activities in which they are most limited by their rhinoconjunctivitis. Patients recall how bothered they have been by their rhinoconjunctivitis during the previous week and to respond to each question on a 7-point scale (0 = not impaired at all - 6 = severely impaired). The overall RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains.
Measured: Baseline, Day 7 and Day 14
Number of responders with an improvement of ≥ 0.5 points in the assessment of overall RQLQ
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) has 28 questions in 7 domains (activity limitation, sleep problems, nose symptoms, eye symptoms, non-nose/eye symptoms, practical problems and emotional function). There are 3 'patient-specific' questions in the activity domain which allow patients to select 3 activities in which they are most limited by their rhinoconjunctivitis. Patients recall how bothered they have been by their rhinoconjunctivitis during the previous week and to respond to each question on a 7-point scale (0 = not impaired at all - 6 = severely impaired). The overall RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains.
Measured: Baseline, Day 7 and Day 14
Intra-group changes in the Rhinitis Control Assessment Test (RCAT) score
Rhinitis Control Assessment Test (RCAT) questionnaire has 6 items that include nasal congestion, sneezing, watery eyes, sleep problems caused by rhinitis, activity avoidance, and nasal or other allergy symptoms control. Responses are measured on a 5-point scales. RCAT scores range from 6 to 30, with higher scores indicating better rhinitis control.
Measured: Baseline, Day 7 and Day 14
Number of responders with a RCAT score ≥22
Rhinitis Control Assessment Test (RCAT) questionnaire has 6 items that include nasal congestion, sneezing, watery eyes, sleep problems caused by rhinitis, activity avoidance, and nasal or other allergy symptoms control. Responses are measured on a 5-point scales. RCAT scores range from 6 to 30, with higher scores indicating better rhinitis control.
Measured: Baseline, Day 7 and Day 14
Onset of action: Instantaneous TNSS
Instantaneous Total Nasal Symptom Score (TNSS) of 4 symptoms (rhinorrhea, sneezing, nasal itching, and nasal congestion) will be assessed by the patient in a patient's diary.
Measured: On Day 2 (first day of treatment) from 0 to 8 hours (at 5 minutes, 15 minutes, 30 minutes, 1 h, 2 h, 4 h, 8 h) after the first dose administration
Onset of action: instantaneous ocular symptoms
Instantaneous Ocular itching and Redness and Ocular tearing will be scored on a 4-point scale where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms.
Measured: On Day 2 (first day of treatment) from 0 to 8 hours (at 5 minutes, 15 minutes, 30 minutes, 1 h, 2 h, 4 h, 8 h) after the first dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start4 Apr 2022
- Primary completion20 Jun 2023
- Study completion20 Jun 2023
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 669 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandoz, Study director, Sandoz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311475
- Sponsor's protocol ID
- CLK21001/SAN-0677
- Other IDs
- 2021-004050-31
- Status last verified
- Jul 2023
- First submitted
- 25 Mar 2022
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo and Active Controlled Parallel-group Trial to Assess the Efficacy and Safety of the Fixed Combination Medicinal Product Mometasone Furoate + Azelastine Hydrochloride Nasal Spray (50 + 140 mcg) in the Treatment of Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT05311475
- Acronym / sponsor ID
- CLK21001/SAN-0677
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 669 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 5 Apr 2022 (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.
The trial will be conducted as a prospective, randomized, multinational, multicenter, double-blind, placebo and active controlled trial in 4 parallel-groups of patients suffering from seasonal allergic rhinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mometasone + Azelastine | Experimental | Drug: Mometasone, Drug: AzelastineMometasone + Azelastine (50 + 140 mcg per actuation) |
| Mometasone | Active comparator | Drug: MometasoneMometasone furoate nasal spray (50 mcg per actuation) |
| Azelastine | Active comparator | Drug: AzelastineAzelastine hydrochloride nasal spray (140 mcg per actuation) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo nasal spray |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Only patients fulfilling all of the following criteria at screening Visit 1 should be included in the present trial:
- Male or non-pregnant, non-lactating female patient aged between 12 and 65 years (valid for Poland) OR between 18 and 65 years (valid for Bulgaria, Moldova and Germany) inclusive on the date of consent.
- Female patient of childbearing potential abstaining from sexual intercourse or using a reliable method of contraception (e.g., condom with spermicide, intra uterine device, oral, injected, transdermal or implanted hormonal contraceptives, or had in the past a female sterilization e.g. tubal ligation, hysterectomy, oophorectomy, salpingectomy) for 30 days before enrolment and agree to continue its use during the trial.
- A minimum of two seasons of previous history of at least moderate seasonal allergic rhinitis (SAR) to the pollen/allergens in season at the time the trial is being conducted.
- Patient must have the following SAR symptoms: (i) nasal congestion, and at least one of the following; (ii) rhinorrhea; (iii) nasal itching; or (iv) sneezing. Nasal congestion plus one other nasal symptom score both rated by the patient as at least moderate in severity (≥2 on a 0-3 scale) and Total Nasal Symptom Score (TNSS) ≥6.0 over the last 24 hours.
Key exclusion criteria (34 listed)
- Simultaneous participation in other clinical trials.
- Use of any investigational drug within 30 days prior to enrolment (Visit 1).
- Clinically significant medical condition (such as cardiovascular, hepatic, neurological, hematological, renal, gastrointestinal, endocrine or other major systemic disease) that, in the judgement of the investigator, would interfere with the trial, require treatment, or make implementation of the protocol or interpretation of the trial results difficult.
- Any known hypersensitivity to azelastine or other antihistamines, mometasone or other steroids, or any of the components of the trial nasal sprays.
- Structural nasal abnormalities symptomatic enough to cause nasal obstruction, as judged by the investigator, or any recent nasal surgery or trauma that is not completely healed.
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 |
|---|---|---|
| MometasoneMometasone furoate nasal spray (50 mcg per actuation) | Drug | Mometasone, Mometasone + Azelastine |
| AzelastineAzelastine hydrochloride nasal spray (140 mcg per actuation) | Drug | Azelastine, Mometasone + Azelastine |
| PlaceboPlacebo nasal spray | Drug | Placebo |
Primary outcome
Change from baseline in the daily Total Nasal Symptom Score (TNSS)
Time frame: Baseline, Day 7
The benefit of the treatment with the fixed combination medicinal product Momeatsone+Azelastine nasal spray (test product) in comparison to the treatment with the individual medicinal products Mometasone nasal spray and Azelastine nasal spray (comparator products) will be assessed by comparing the change from baseline in the daily Total Nasal Symptom Score (TNSS) during the first seven days of treatment. Total Nasal Symptom Score (TNSS) of 4 symptoms (rhinorrhea, sneezing, nasal itching, and nasal congestion) will be assessed by the patient in a patient's diary. Each symptom will be scored on a 4-point scale where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms, such that the maximum TNSS is 12.
11 secondary outcomes
Change from baseline in the daily Total Nasal Symptom Score (TNSS)
Time frame: Baseline, Day 14
Change from baseline in individual daily nasal symptoms
Time frame: Baseline, Day 7 and Day 14
Change from baseline in individual daily ocular symptoms
Time frame: Baseline, Day 7 and Day 14
Baseline-adjusted differences in nasal obstruction assessed by peak nasal inspiratory flow measurements (PNIF)
Time frame: Baseline, Day 7 and Day 14
Change from baseline in Rhinoscopy score
Time frame: Baseline, Day 7 and Day 14
Intra-group changes in health-related Quality of Life (RQLQ)
Time frame: Baseline, Day 7 and Day 14
Number of responders with an improvement of ≥ 0.5 points in the assessment of overall RQLQ
Time frame: Baseline, Day 7 and Day 14
Intra-group changes in the Rhinitis Control Assessment Test (RCAT) score
Time frame: Baseline, Day 7 and Day 14
Number of responders with a RCAT score ≥22
Time frame: Baseline, Day 7 and Day 14
Onset of action: Instantaneous TNSS
Time frame: On Day 2 (first day of treatment) from 0 to 8 hours (at 5 minutes, 15 minutes, 30 minutes, 1 h, 2 h, 4 h, 8 h) after the first dose administration
Onset of action: instantaneous ocular symptoms
Time frame: On Day 2 (first day of treatment) from 0 to 8 hours (at 5 minutes, 15 minutes, 30 minutes, 1 h, 2 h, 4 h, 8 h) after the first dose administration
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 11 Jul 2023.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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.
Sandoz study director
Sandoz
28 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mometasone and Azelastine in people with Seasonal Allergic Rhinitis, run by Sandoz at 28 sites in 4 countries.
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 13 inclusion and 34 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 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Germany, Poland, Bulgaria, Moldova. 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 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 from baseline in the daily Total Nasal Symptom Score (TNSS) (time frame: Baseline, Day 7). 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 11 Jul 2023.