Allergic RhinitisPhase 3NCT04264637
Study to Find Out How Long it Takes Azelastine Hydrochloride 0.15% Nasal Spray to Relieve Symptoms in Patients Suffering From Allergic Rhinitis
A Phase 3 study testing Azelastine hydrochloride (BAYR9258) in people with Allergic Rhinitis, run by Bayer at 1 site in Canada.
Trial summary
In this study researchers want to learn how quickly patients suffering from allergic rhinitis (also known as hay fever) can expect symptom relief after using Azelastine Hydrochloride 0.15% Nasal Spray. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Azelastine hydrochloride (BAYR9258)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteCanada
- Study dates
- 3 Feb 2020to 17 Mar 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, ambulatory, male or female volunteers 18 to 65 years of age with selfreported allergic rhinitis to ragweed pollen for at least 2 years prior.
- Documented positive skin prick test response to common ragweed (ambrosia artemisiifolia) pollen; prick with wheal ≥3 mm larger than the diluent response at screening or within the previous 12 months done at the research site.
- Subject is willing to abstain use of any decongestant and/or allergy medications (prescription and over-the-counter), smoking, wearing perfume and alcohol 24 hours prior to the Qualification and Treatment Phases as instructed.
- Subject is willing to stop use of current decongestant and allergy medications at the start of the washout period prior to qualification and during the trial as instructed.
- At the discretion of the investigator, subjects may be considered with self-reported mild intermittent asthma (using ≤2 doses of SABA (short-acting beta agonists) per week) or exercise-induced asthma.
- Female subjects of childbearing potential must: a) be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives); b) abstain from sexual intercourse for at least 1 month prior to screening; or c) participate exclusively in a same sex relationship for at least 1 month prior to screening. In addition, female subjects of childbearing potential must have a negative pregnancy test at Screening and prior to entering the Environmental Exposure Chamber (EEC). Female subjects of non-childbearing potential must be amenorrheic for at least two years or have undergone surgical sterilization (i.e. tubal ligation/occlusion, hysterectomy and/or bilateral oophorectomy).
- At the end of the 4 hour Qualification Phase, the subject's Total Nasal Symptom Score (TNSS) via Electronic Patient Data Acquisition Tablet (ePDAT) must be ≥6 out of a possible of 12 at least twice, with at least one occurring during the last 2 time points to qualify to receive study intervention.
- During Treatment Phases Treatment 1 (T1) and Treatment 2 (T2), subjects are exposed to pollen in EEC for a two hour induction phase. At the end of the two hour symptom induction phase during T1 and T2, subjects meet a minimum threshold total nasal symptom score (TNSS) response of ≥6 out of a possible of 12 at least twice, with at least one occurring during the last 2 time points to qualify to receive study intervention.
Who cannot join
- Any significant medical condition which, in the judgment of the investigator, is a contraindication to the use of intranasal azelastine hydrochloride (HCl), or might interfere with the trial.
- Subjects with a pre-EEC TNSS ˃3 at T1.
- Subjects with a known allergy to azelastine HCl or any of its inactive ingredients, or with a known contraindication to the use of epinephrine.
- Subjects with a known history of non-allergic rhinitis.
- Subjects with a suspected or known history of anaphylaxis to ragweed allergen.
- Subjects with a suspected or known history of rhinitis medicamentosa.
Show all 12Show fewer
- In the judgment of the investigator, any respiratory illness or active local infection (e.g., sinusitis) prior to the Qualification Phase that can interfere with the conduct of the study.
- Subjects with a known history of coronary heart disease, ischemic heart disease , high blood pressure, symptomatic prostatic hypertrophy, hepatic insufficienHas a history of immunological disease or malignancy within the past 5 years, with the exception of non-melanoma skin cancer or renal disease.
- Evidence or history of clinically significant (in the judgment of the investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular (including hypertension), hepatic, psychiatric, neurologic diseases, or malignancies within the last 5 years.
- Self-reported medical history of tuberculosis, hepatitis or human immunodeficiency virus (HIV).
- Alcoholism or drug abuse within 2 years prior to the Screening Visit or routine consumption of 3 or more alcohol containing beverages per day; Alcohol containing beverages are defined as one beer (5%), one glass of wine (11%) and one shot (40%) hard liquor.
- Self-reported current heavy smokers (>1 pack/25 cigarettes per day).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled, Crossover Study to Evaluate the Onset of Efficacy of Azelastine Hydrochloride 0.15% Nasal Spray in Allergic Rhinitis Sufferers Following Pollen Exposure in an Environmental Exposure Chamber
In this study researchers want to learn how quickly patients suffering from allergic rhinitis (also known as hay fever) can expect symptom relief after using Azelastine Hydrochloride 0.15% Nasal Spray.
This study plans to enrol about 80 male or female participants in the age of 18 to 65 years suffering from an allergic rhinitis to ragweed pollen for at least 2 years. In a first phase participants will be exposed to ragweed pollen in a special study room to ensure they will be adequately symptomatic when they progress into the treatment phase of the study. In a second phase study participants will be divided in 2 groups. After exposure to ragweed pollen one group will receive Azelastine Hydrochloride 0.15% Nasal Spray and the other group will receive placebo (a nasal spray which does not contain any active drug substance). In the third phase of study the treatment will be switched: participants who received in the previous study Azelastine Hydrochloride 0.15% Nasal Spray will receive the nasal spray without any active drug substance and the other group will receive Azelastine Hydrochloride 0.15% Nasal Spray. During the second and third study phase the researchers will examine thoroughly over 4 hours the change of nasal symptoms such as runny nose, itchy nose, sneezing and nasal congestion after participants received the nasal spray.
- Conditions
- Allergic Rhinitis
- Being tested
- Azelastine hydrochloride (BAYR9258), Placebo
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azelastine hydrochloride (BAYR9258)Drug
Single dose, metered-spray solution, 2 sprays per nostril, 205.5 mcg/spray, intranasal administration.
PlaceboDrug
Single dose of Azelastine hydrochloride-matched placebo, metered-spray solution, 2 sprays per nostril, intranasal administration.
| Study group | Role | What they receive |
|---|---|---|
| Azelastine hydrochloride 0.15% + Placebo | Experimental | Each participant will receive a single dose (two sprays per nostril) of study intervention Azelastine hydrochloride 0.15% and Placebo at treatment period 1 and 2 respectively. Receives: Drug: Azelastine hydrochloride (BAYR9258); Drug: Placebo |
| Placebo + Azelastine hydrochloride 0.15% | Experimental | Each participant will receive a single dose (two sprays per nostril) of study intervention Placebo and Azelastine hydrochloride 0.15% at treatment period 1 and 2 respectively. Receives: Drug: Azelastine hydrochloride (BAYR9258); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total nasal symptom score (TNSS)
Evaluated by rating the following symptoms (sneezing, runny nose, itchy nose, and nasal congestion) on a scale from 0-3 (0 = None, 1= Mild symptoms, 2 = Moderate symptoms, 3 = Severe symptoms)
Measured: 4 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start3 Feb 2020
- Primary completion17 Mar 2021
- Study completion17 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264637
- Sponsor's protocol ID
- 20877
- Status last verified
- Mar 2022
- First submitted
- 10 Feb 2020
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Publications
Hsu SN, Sajjad F, Brigham E, Centofanti R, An R, Couroux P, Ng C. Onset of efficacy of azelastine hydrochloride 0.15% nasal spray for allergic rhinitis in an environmental exposure chamber. Ann Allergy Asthma Immunol. 2024 Dec;133(6):675-681. doi: 10.1016/j.anai.2024.07.020. Epub 2024 Jul 26.
PubMed 39067509
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled, Crossover Study to Evaluate the Onset of Efficacy of Azelastine Hydrochloride 0.15% Nasal Spray in Allergic Rhinitis Sufferers Following Pollen Exposure in an Environmental Exposure Chamber
- ClinicalTrials.gov ID
- NCT04264637
- Acronym / sponsor ID
- 20877
- Conditions
- Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 17 Mar 2021 (actual)
- Study completion
- 17 Mar 2021 (actual)
- First posted
- 11 Feb 2020 (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.
In this study researchers want to learn how quickly patients suffering from allergic rhinitis (also known as hay fever) can expect symptom relief after using Azelastine Hydrochloride 0.15% Nasal Spray.
This study plans to enrol about 80 male or female participants in the age of 18 to 65 years suffering from an allergic rhinitis to ragweed pollen for at least 2 years. In a first phase participants will be exposed to ragweed pollen in a special study room to ensure they will be adequately symptomatic when they progress into the treatment phase of the study. In a second phase study participants will be divided in 2 groups. After exposure to ragweed pollen one group will receive Azelastine Hydrochloride 0.15% Nasal Spray and the other group will receive placebo (a nasal spray which does not contain any active drug substance). In the third phase of study the treatment will be switched: participants who received in the previous study Azelastine Hydrochloride 0.15% Nasal Spray will receive the nasal spray without any active drug substance and the other group will receive Azelastine Hydrochloride 0.15% Nasal Spray. During the second and third study phase the researchers will examine thoroughly over 4 hours the change of nasal symptoms such as runny nose, itchy nose, sneezing and nasal congestion after participants received the nasal spray.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azelastine hydrochloride 0.15% + Placebo | Experimental | Drug: Azelastine hydrochloride (BAYR9258), Drug: PlaceboEach participant will receive a single dose (two sprays per nostril) of study intervention Azelastine hydrochloride 0.15% and Placebo at treatment period 1 and 2 respectively. |
| Placebo + Azelastine hydrochloride 0.15% | Experimental | Drug: Azelastine hydrochloride (BAYR9258), Drug: PlaceboEach participant will receive a single dose (two sprays per nostril) of study intervention Placebo and Azelastine hydrochloride 0.15% at treatment period 1 and 2 respectively. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy, ambulatory, male or female volunteers 18 to 65 years of age with selfreported allergic rhinitis to ragweed pollen for at least 2 years prior.
- Documented positive skin prick test response to common ragweed (ambrosia artemisiifolia) pollen; prick with wheal ≥3 mm larger than the diluent response at screening or within the previous 12 months done at the research site.
- Subject is willing to abstain use of any decongestant and/or allergy medications (prescription and over-the-counter), smoking, wearing perfume and alcohol 24 hours prior to the Qualification and Treatment Phases as instructed.
- Subject is willing to stop use of current decongestant and allergy medications at the start of the washout period prior to qualification and during the trial as instructed.
- At the discretion of the investigator, subjects may be considered with self-reported mild intermittent asthma (using ≤2 doses of SABA (short-acting beta agonists) per week) or exercise-induced asthma.
Key exclusion criteria (12 listed)
- Any significant medical condition which, in the judgment of the investigator, is a contraindication to the use of intranasal azelastine hydrochloride (HCl), or might interfere with the trial.
- Subjects with a pre-EEC TNSS ˃3 at T1.
- Subjects with a known allergy to azelastine HCl or any of its inactive ingredients, or with a known contraindication to the use of epinephrine.
- Subjects with a known history of non-allergic rhinitis.
- Subjects with a suspected or known history of anaphylaxis to ragweed allergen.
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 |
|---|---|---|
| Azelastine hydrochloride (BAYR9258)Single dose, metered-spray solution, 2 sprays per nostril, 205.5 mcg/spray, intranasal administration. | Drug | Azelastine hydrochloride 0.15% + Placebo, Placebo + Azelastine hydrochloride 0.15% |
| PlaceboSingle dose of Azelastine hydrochloride-matched placebo, metered-spray solution, 2 sprays per nostril, intranasal administration. | Drug | Azelastine hydrochloride 0.15% + Placebo, Placebo + Azelastine hydrochloride 0.15% |
Primary outcome
Total nasal symptom score (TNSS)
Time frame: 4 hours post dose
Evaluated by rating the following symptoms (sneezing, runny nose, itchy nose, and nasal congestion) on a scale from 0-3 (0 = None, 1= Mild symptoms, 2 = Moderate symptoms, 3 = Severe symptoms)
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 25 Mar 2022.
- Derived from this study: PubMed 39067509Hsu SN, Sajjad F, Brigham E, Centofanti R, An R, Couroux P, Ng C. Onset of efficacy of azelastine hydrochloride 0.15% nasal spray for allergic rhinitis in an environmental exposure chamber. Ann Allergy Asthma Immunol. 2024 Dec;133(6):675-681. doi: 10.1016/j.anai.2024.07.020. Epub 2024 Jul 26.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Azelastine hydrochloride (BAYR9258) in people with Allergic Rhinitis, run by Bayer 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 8 inclusion and 12 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 25 Mar 2022. 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 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?
Total nasal symptom score (TNSS) (time frame: 4 hours post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04264637, which also lists 1 linked publication.
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 25 Mar 2022.