Seasonal Allergic RhinitisPhase 4NCT03004131
MP-AzeFlu Allergen Chamber - Onset of Action Study
A Phase 4 study testing Azelastine hydrochloride + fluticasone propionate nasal spray and fluticasone propionate nasal spray + loratadine 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 (MP-AzeFlu) in treating the nasal symptoms of seasonal allergic rhinitis (SAR) induced by an allergen challenge in an Environmental Exposure Chamber (EEC). 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?
- Azelastine hydrochloride + fluticasone propionate nasal spray and fluticasone propionate nasal spray + loratadine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteCanada
- Study dates
- 7 Jan 2017to 29 Mar 2017
- Phase
- Phase 4
- 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
Who may be able to join
- Provide written informed consent.
- Male or female subjects (childbearing and non-childbearing potential, defined as females with no menstruation for a minimum of 12 months prior to screening) 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 in the previous 12 months may be used to qualify the subject.
- To be eligible for Visit 2 EEC, a subject must additionally comply with the following criteria:
- Asymptomatic or with mild symptoms during the baseline recording of symptoms prior to start of the screening EEC (Visit 2):
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- 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 EEC:
- Demonstrate adequate symptomology:
- TNSS ≥ 6/12 on at least two ePDAT™ time point assessments during hours 0-2 in the EEC (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 EEC, with at least one occurring during the last two time points.
- To be eligible for randomisation (Visit 3), a subject must additionally comply with the following criteria:
- Demonstrate adequate symptomology:
- TNSS ≥ 6/12 on at least two ePDAT™ time point assessments during hours 0-2 in the EEC (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 EEC, 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 fluticasone propionate, azelastine hydrochloride, loratadine, 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 FEV1 <75% of the predicted value.
- 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 IUDs, tubal ligation or vasectomised partner 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,Theophylline, Cromolyn sodium, Corticosteroids, Decongestants, Immunotherapy, Systemic antibiotics, any cytochrome P450 3A4 inhibiting or inducing drug [e.g. ritonavir, ketoconazole, itraconazole, erythromycin, cimetidine, rifampicin, St. John's wort (Hypericum perforatum) etc.], Tricyclic antidepressants and MAO inhibitors ); and use of any medication considered to have an influence on the outcome of the study during the EEC session, at the discretion of the Investigator and/or designee.
- Subjects with (expected) clinically relevant symptoms at the timing of the scheduled EEC assessments due to concomitant sensitization, i.e., positive SPT (mean wheal diameter at least 3 mm larger than the negative control) and a 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 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, including acute conjunctivitis or any other ocular infection.
- History of increased ocular pressure, glaucoma and/or cataracts.
- 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, as judged by the Investigator.
- Exposure to chickenpox or measles within 4 weeks prior to the screening visit or during the study.
- History of chronic sinusitis or history of non-allergic rhinitis.
- 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 kept in detention).
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 (MP-AzeFlu) in the Treatment of Allergen-Induced Allergic Rhinitis Symptoms in Comparison to Placebo and Free Combination of Fluticasone Propionate Nasal Spray and Oral Loratadine
This study is to assess the onset of action of fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray (MP-AzeFlu) in treating the nasal symptoms of seasonal allergic rhinitis (SAR) induced by an allergen challenge in an Environmental Exposure Chamber (EEC).
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Azelastine hydrochloride + fluticasone propionate nasal spray, Placebos, fluticasone propionate nasal spray + loratadine
- 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.
Azelastine hydrochloride + fluticasone propionate nasal sprayDrug
PlacebosDrug
fluticasone propionate nasal spray + loratadineDrug
| Study group | Role | What they receive |
|---|---|---|
| fixed drug combination | Experimental | MP29-02 or MP-AzuFlu as fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray (Dymista) plus Placebo tablet Receives: Drug: Azelastine hydrochloride + fluticasone propionate nasal spray |
| Placebo | Placebo comparator | Nasal spray with no active dose plus Placebo tablet Receives: Drug: Placebos |
| active control | Active comparator | fluticasone propionate nasal spray (Flonase) plus loratadine 10 mg tablets (Claritin) Receives: Drug: fluticasone propionate nasal spray + loratadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Nasal Symptom Score (TNSS); change from baseline over the last 4 hours of exposure in an Environmental Exposure Chamber (EEC)
Measured: Onset of action (first significant difference to placebo) up to 4 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study start7 Jan 2017
- Primary completion29 Mar 2017
- Study completion29 Mar 2017
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- MEDA Pharma GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christine Kolb, Study director, MEDA Pharma GmbH & Co. KG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004131
- Sponsor's protocol ID
- X-03065-3311
- Status last verified
- May 2017
- First submitted
- 16 Dec 2016
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. 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 (MP-AzeFlu) in the Treatment of Allergen-Induced Allergic Rhinitis Symptoms in Comparison to Placebo and Free Combination of Fluticasone Propionate Nasal Spray and Oral Loratadine
- ClinicalTrials.gov ID
- NCT03004131
- Acronym / sponsor ID
- X-03065-3311
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- MEDA Pharma GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2017 (actual)
- Primary completion
- 29 Mar 2017 (actual)
- Study completion
- 29 Mar 2017 (actual)
- First posted
- 28 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to assess the onset of action of fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray (MP-AzeFlu) in treating the nasal symptoms of seasonal allergic rhinitis (SAR) induced by an allergen challenge in an Environmental Exposure Chamber (EEC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| fixed drug combination | Experimental | Drug: Azelastine hydrochloride + fluticasone propionate nasal sprayMP29-02 or MP-AzuFlu as fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray (Dymista) plus Placebo tablet |
| Placebo | Placebo comparator | Drug: PlacebosNasal spray with no active dose plus Placebo tablet |
| active control | Active comparator | Drug: fluticasone propionate nasal spray + loratadinefluticasone propionate nasal spray (Flonase) plus loratadine 10 mg tablets (Claritin) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Provide written informed consent.
- Male or female subjects (childbearing and non-childbearing potential, defined as females with no menstruation for a minimum of 12 months prior to screening) 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 in the previous 12 months may be used to qualify the subject.
- To be eligible for Visit 2 EEC, a subject must additionally comply with the following criteria:
Key exclusion criteria (22 listed)
- History of allergic reaction to fluticasone propionate, azelastine hydrochloride, loratadine, 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 FEV1 <75% of the predicted value.
- 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 IUDs, tubal ligation or vasectomised partner started at least 4 weeks prior to screening.
- Previous and concomitant treatments: use of prohibited therapies (Antihistaminic agents,Theophylline, Cromolyn sodium, Corticosteroids, Decongestants, Immunotherapy, Systemic antibiotics, any cytochrome P450 3A4 inhibiting or inducing drug [e.g. ritonavir, ketoconazole, itraconazole, erythromycin, cimetidine, rifampicin, St. John's wort (Hypericum perforatum) etc.], Tricyclic antidepressants and MAO inhibitors ); and use of any medication considered to have an influence on the outcome of the study during the EEC 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 |
|---|---|---|
| Azelastine hydrochloride + fluticasone propionate nasal spray | Drug | fixed drug combination |
| Placebos | Drug | Placebo |
| fluticasone propionate nasal spray + loratadine | Drug | active control |
Primary outcome
Total Nasal Symptom Score (TNSS); change from baseline over the last 4 hours of exposure in an Environmental Exposure Chamber (EEC)
Time frame: Onset of action (first significant difference to placebo) up to 4 hours.
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 22 Feb 2022.
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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.
Christine Kolb study director
MEDA Pharma GmbH & Co. KG
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 Azelastine hydrochloride + fluticasone propionate nasal spray and fluticasone propionate nasal spray + loratadine 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 14 inclusion and 22 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 22 Feb 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. 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 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?
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); change from baseline over the last 4 hours of exposure in an Environmental Exposure Chamber (EEC) (time frame: Onset of action (first significant difference to placebo) up to 4 hours.). 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 22 Feb 2022.