Seasonal Allergic RhinitisPhase 4NCT04652245
Dymista Allergen Chamber - Onset of Action Study
A Phase 4 study testing Treatment A (Dymista): Fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray at Visit 3 and Treatment A (Dymista): Fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray at Visit 5 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 of fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray (Dymista) in treating the nasal symptoms of seasonal allergic rhinitis (SAR) induced by an allergen challenge in an Environmental Exposure Unit (EEU). 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 (Dymista): Fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray at Visit 3 and Treatment A (Dymista): Fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray at Visit 5
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 1 siteCanada
- Study dates
- 14 Dec 2020to 13 Dec 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Provide written informed consent.
- 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 Follicle-Stimulating Hormone (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.
- Willingness to complete all study visits.
- To be eligible for Visit 2 EEU, a subject must additionally comply with the following criteria:
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- Asymptomatic or with mild symptoms during the baseline recording of symptoms prior to start of the screening EEU (Visit 2):
- Total Nasal Symptom Score (TNSS) ≤ 3/12 with the score for each symptom being less than 2.
- To be eligible for Visit 3, a subject must additionally comply with the following criteria during Visit 2 EEU:
- Demonstrate adequate symptomology:
- TNSS ≥ 6/12 on at least two Electronic Patient Data Acquisition Tablet (ePDAT TM) time point assessments during hours 0-2 in the EEU (Visit 2), with at least one occurring during the last two time points. Additionally, subjects will be required to meet a score of at least 2/3 for runny nose at least twice during hours 0-2 in the EEU, with at least one occurring during the last two time points.
- To be eligible for randomization (Visit 3), a subject must additionally comply with the following criteria:
- Demonstrate adequate symptomology:
- TNSS ≥ 6/12 on at least two ePDATTM time point assessments during hours 0-2 in the EEU (Visit 3), with at least one occurring during the last two time points. Additionally, subjects will be required to meet a score of at least 2/3 for runny nose at least twice during hours 0-2 in the EEU, with at least one occurring during the last two time points.
- No evidence of complete nasal blockage on either one or both sides on anterior rhinoscopy within 30 minutes prior to dosing.
Who cannot join
- Safety concerns:
- History of allergic reaction to azelastine hydrochloride or fluticasone propionate or one of the excipients of the study treatments (e.g. benzalkonium chloride, phenylethyl alcohol, microcrystalline cellulose) or a component of the container.
- History of anaphylaxis, cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, 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. Women of childbearing potential not abstinent or using a highly effective method of birth control defined as those which result in a low failure rate (i.e. <1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal Intrauterine Devices (IUDs), barrier methods, or tubal ligation started at least 4 weeks prior to screening.
- Lack of suitability for the study:
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- Previous and concomitant treatments: use of prohibited therapies (Antihistaminic agents, all presentations; Theophylline, all presentations; Cromolyn sodium, all forms; Nedocromil sodium; Salbutamol, all presentations; Leukotriene modifiers, all presentations; Corticosteroids (inhaled, oral, intravenous); Topical corticosteroids (ocular, intranasal); Corticosteroids (intramuscular or intra-articular); Decongestants, all forms; Immunotherapy; Systemic antibiotics; Tricyclic antidepressants and Monoamine Oxidase (MAO) inhibitors; Any cytochrome P450 3A4 inhibiting or inducing drug (e.g. ritonavir, cobicistat, ketoconazole, itraconazole, erythromycin, cimetidine, rifampicin, St. John's wort (Hypericum perforatum) etc.) not allowed within specific time frames prior to Screening and/or not allowed/allowed only with restrictions during the study, as specified in the study protocol; use of any medication considered to have an influence on the outcome of the study during the EEU session, at the discretion of the Investigator and/or designee.
- Subjects with (expected) clinically relevant symptoms at the timing of the scheduled EEU assessments due to concomitant allergies, i.e. history of allergic response to the causative allergen, at the discretion of the Investigator. Subjects with a positive SPT for cats and/or dogs are acceptable if the subject avoids cats and/or dogs for the duration of the study.
- Concomitant diseases: abnormalities during the screening visit (Visit 1) or Visit 2 that might interfere with study results as determined by the Investigator and/or designee.
- Presence of a severely deviated septum, septal perforation, structural nasal defect or large nasal polyps causing obstruction as determined by the Investigator.
- Acute conditions: any acute illness within 7 days prior to the screening visit (Visit 1) or Visit 2, including acute conjunctivitis or any other ocular infection, at the discretion of the Investigator and/or designee.
- History of increased ocular pressure, glaucoma, cataracts, and/or central serous chorioretinopathy (CSCR).
- Presence of or ongoing tuberculosis, untreated local or systemic fungal or bacterial infections, systemic viral or parasitic infections or ocular herpes simplex.
- Recent nasal ulcers, mucosal erosion, nasal surgery, or nasal trauma, that might interfere with study results as determined by the Investigator and/or designee.
- Exposure to chickenpox or measles within 4 weeks prior to the screening visit or during the study.
- Acute or chronic sinusitis or non-allergic rhinitis, at the discretion of the Investigator and/or designee.
- Exposure to another investigational product within the last 30 days prior to screening.
- History of malignancy within the past five years, except for basal cell skin carcinomas that have been treated with no recurrence for at least 3 months.
- Neurological or psychiatric disease or drug or alcohol abuse which would interfere with the subject's proper completion of the protocol assignment. Subjects with a positive urine drug screen will be excluded.
- Subjects undergoing surgical procedures with general anaesthesia within 90 days prior to screening or who plan to undergo surgery/hospitalization during the study.
- Administrative reasons:
- Vulnerable subjects (such as persons who are institutionalized).
- Positive alcohol or drug test during screening visit (Visit 1)
- Public health emergency (e.g. COVID-19): subjects not complying to Public health guidelines (e.g. self isolation etc.), at the discretion of the Investigator's and/or designee, or subjects with a positive COVID-test at Visit 2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial to Assess Onset of Action of Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray Delivered in a Single Spray (Dymista) in the Treatment of Allergen-Induced Allergic Rhinitis Symptoms in Comparison to Placebo in an Environmental Exposure Unit (EEU)
This study is to assess the onset of action of fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray (Dymista) in treating the nasal symptoms of seasonal allergic rhinitis (SAR) induced by an allergen challenge in an Environmental Exposure Unit (EEU).
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Treatment A (Dymista): Fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray at Visit 3, Treatment B (Placebo): Nasal spray with no active dose (Dymista vehicle) at Visit 5, Treatment A (Dymista): Fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray at Visit 5, Treatment B (Placebo): Nasal spray with no active dose (Dymista vehicle) at Visit 3
- 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 (Dymista): Fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray at Visit 3Drug
Single dose, one spray in each nostril of Dymista nasal spray, approximately 137 μg of azelastine hydrochloride and 50 μg of fluticasone propionate per actuation, at Visit 3
Treatment B (Placebo): Nasal spray with no active dose (Dymista vehicle) at Visit 5Drug
Single dose, one spray in each nostril of Placebo nasal spray at Visit 5
Treatment A (Dymista): Fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray at Visit 5Drug
Single dose, one spray in each nostril of Dymista nasal spray, approximately 137 μg of azelastine hydrochloride and 50 μg of fluticasone propionate per actuation, at Visit 5
Treatment B (Placebo): Nasal spray with no active dose (Dymista vehicle) at Visit 3Drug
Single dose, one spray in each nostril of Placebo nasal spray, at Visit 3
| Study group | Role | What they receive |
|---|---|---|
| Treatment A (Dymista) and Treatment B (Placebo), separated by at least 14 days of wash-out period | Experimental | Fixed drug combination of Azelastine hydrochloride 137 μg / Fluticasone propionate 50 μg nasal spray and Placebo nasal spray Receives: Drug: Treatment A (Dymista): Fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray at Visit 3; Drug: Treatment B (Placebo): Nasal spray with no active dose (Dymista vehicle) at Visit 5 |
| Treatment B (Placebo) and Treatment A (Dymista), separated by at least 14 days of wash-out period | Experimental | Placebo nasal spray and Fixed drug combination of Azelastine hydrochloride 137 μg / Fluticasone propionate 50 μg nasal spray Receives: Drug: Treatment A (Dymista): Fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray at Visit 5; Drug: Treatment B (Placebo): Nasal spray with no active dose (Dymista vehicle) at Visit 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient-assessed Instantaneous Total Nasal Symptom Score (TNSS) From Baseline Compared to Placebo
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.
In this study, the first significant difference to placebo of TNSS was observed at 5 minutes time point (= onset of action).
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 (1)
Change in Patient-assessed Instantaneous Total Ocular Symptom Score (TOSS) From Baseline Compared to Placebo
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.
In this study, the first significant difference to placebo of TOSS was observed at 10 minutes time point (= onset of action).
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start14 Dec 2020
- Primary completion4 Dec 2021
- Study completion13 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study will be a single-center, randomized, placebo-controlled, double-blind, and two-period cross-over trial.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- MEDA Pharma GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Couroux, Dr., Principal investigator, Cliantha Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652245
- Sponsor's protocol ID
- AZFL-AES-4-001
- Other IDs
- C1D00571
- Status last verified
- Feb 2023
- First submitted
- 20 Nov 2020
- Last updated
- 23 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Assess Onset of Action of Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray Delivered in a Single Spray (Dymista) in the Treatment of Allergen-Induced Allergic Rhinitis Symptoms in Comparison to Placebo in an Environmental Exposure Unit (EEU)
- ClinicalTrials.gov ID
- NCT04652245
- Acronym / sponsor ID
- AZFL-AES-4-001
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- MEDA Pharma GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 4 Dec 2021 (actual)
- Study completion
- 13 Dec 2021 (actual)
- First posted
- 3 Dec 2020 (actual)
- Results
- Posted 23 Mar 2023
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 of fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray (Dymista) in treating the nasal symptoms of seasonal allergic rhinitis (SAR) induced by an allergen challenge in an Environmental Exposure Unit (EEU).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The study will be a single-center, randomized, placebo-controlled, double-blind, and two-period cross-over trial.
| Arm | Type | Receives |
|---|---|---|
| Treatment A (Dymista) and Treatment B (Placebo), separated by at least 14 days of wash-out period | Experimental | Drug: Treatment A (Dymista): Fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray at Visit 3, Drug: Treatment B (Placebo): Nasal spray with no active dose (Dymista vehicle) at Visit 5Fixed drug combination of Azelastine hydrochloride 137 μg / Fluticasone propionate 50 μg nasal spray and Placebo nasal spray |
| Treatment B (Placebo) and Treatment A (Dymista), separated by at least 14 days of wash-out period | Experimental | Drug: Treatment A (Dymista): Fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray at Visit 5, Drug: Treatment B (Placebo): Nasal spray with no active dose (Dymista vehicle) at Visit 3Placebo nasal spray and Fixed drug combination of Azelastine hydrochloride 137 μg / Fluticasone propionate 50 μg nasal spray |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Provide written informed consent.
- 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 Follicle-Stimulating Hormone (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.
- Willingness to complete all study visits.
Key exclusion criteria (24 listed)
- History of allergic reaction to azelastine hydrochloride or fluticasone propionate or one of the excipients of the study treatments (e.g. benzalkonium chloride, phenylethyl alcohol, microcrystalline cellulose) or a component of the container.
- History of anaphylaxis, cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, 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. Women of childbearing potential not abstinent or using a highly effective method of birth control defined as those which result in a low failure rate (i.e. <1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal Intrauterine Devices (IUDs), barrier methods, or tubal ligation started at least 4 weeks prior to screening.
- Previous and concomitant treatments: use of prohibited therapies (Antihistaminic agents, all presentations; Theophylline, all presentations; Cromolyn sodium, all forms; Nedocromil sodium; Salbutamol, all presentations; Leukotriene modifiers, all presentations; Corticosteroids (inhaled, oral, intravenous); Topical corticosteroids (ocular, intranasal); Corticosteroids (intramuscular or intra-articular); Decongestants, all forms; Immunotherapy; Systemic antibiotics; Tricyclic antidepressants and Monoamine Oxidase (MAO) inhibitors; Any cytochrome P450 3A4 inhibiting or inducing drug (e.g. ritonavir, cobicistat, ketoconazole, itraconazole, erythromycin, cimetidine, rifampicin, St. John's wort (Hypericum perforatum) etc.) not allowed within specific time frames prior to Screening and/or not allowed/allowed only with restrictions during the study, as specified in the study protocol; use of any medication considered to have an influence on the outcome of the study during the EEU session, at the discretion of the Investigator and/or designee.
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 (Dymista): Fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray at Visit 3Single dose, one spray in each nostril of Dymista nasal spray, approximately 137 μg of azelastine hydrochloride and 50 μg of fluticasone propionate per actuation, at Visit 3 | Drug | Treatment A (Dymista) and Treatment B (Placebo), separated by at least 14 days of wash-out period |
| Treatment B (Placebo): Nasal spray with no active dose (Dymista vehicle) at Visit 5Single dose, one spray in each nostril of Placebo nasal spray at Visit 5 | Drug | Treatment A (Dymista) and Treatment B (Placebo), separated by at least 14 days of wash-out period |
| Treatment A (Dymista): Fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray at Visit 5Single dose, one spray in each nostril of Dymista nasal spray, approximately 137 μg of azelastine hydrochloride and 50 μg of fluticasone propionate per actuation, at Visit 5 | Drug | Treatment B (Placebo) and Treatment A (Dymista), separated by at least 14 days of wash-out period |
| Treatment B (Placebo): Nasal spray with no active dose (Dymista vehicle) at Visit 3Single dose, one spray in each nostril of Placebo nasal spray, at Visit 3 | Drug | Treatment B (Placebo) and Treatment A (Dymista), separated by at least 14 days of wash-out period |
Primary outcome
Change in Patient-assessed Instantaneous Total Nasal Symptom Score (TNSS) From Baseline Compared to Placebo
Time frame: 0 to 4 hours post application
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. In this study, the first significant difference to placebo of TNSS was observed at 5 minutes time point (= onset of action). 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.
1 secondary outcome
Change in Patient-assessed Instantaneous Total Ocular Symptom Score (TOSS) From Baseline Compared to Placebo
Time frame: 0 to 4 hours post application
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Peter 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 4 study testing Treatment A (Dymista): Fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray at Visit 3 and Treatment A (Dymista): Fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray at Visit 5 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?
The sponsor lists 15 inclusion and 24 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 23 Mar 2023. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Patient-assessed Instantaneous Total Nasal Symptom Score (TNSS) From Baseline Compared to Placebo (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 23 Mar 2023.