Rhinitis, AllergicPhase 4NCT03443843
A Study to Evaluate Changes in Nasal Airflow of Loratadine/Pseudoephedrine Tablet and Fluticasone Propionate Nasal Spray in Subjects Following Allergen Exposure
A Phase 4 study testing loratadine + pseudoephedrine sulfate (BAY818725/Claritin-D) and Fluticasone Propionate in people with Rhinitis, Allergic, run by Bayer at 1 site in Canada.
Trial summary
The purpose of the study is to evaluate changes in nasal airflow caused by loratadine 5 mg/pseudoephedrine sulfate 120 mg (Claritin D) tablet and fluticasone propionate 50 mcg per spray nasal spray (Flonase) in subjects suffering from nasal congestion and other allergy symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rhinitis, Allergic
- What is being tested?
- loratadine + pseudoephedrine sulfate (BAY818725/Claritin-D) and Fluticasone Propionate
- 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
- 21 Feb 2018to 11 May 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy, ambulatory male and female subjects between 18 to 65 years of age
- Self-reported seasonal allergic rhinitis to ragweed pollen for at least 2 years prior to screening
- Documented positive skin prick test response to common ragweed (ambrosia artemisiifolia) pollen at screening or within the previous 12 months conducted at research site (prick with wheal diameter >= 5 mm larger than the diluent response)
- In order to qualify to continue to treatment phase, at the end of priming phase (which is 3 hours), Total Symptom Score (TSS) has to be ≥ 7, with nasal congestion score alone ≥ 2 and change in peak nasal inspiratory flow (PNIF) has to be ≥ 15% from pre-prime baseline;
- Subject is willing to stop use of current decongestant and allergy medications at the start of the washout period prior to priming and during the trial
- At the discretion of the investigators, 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
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- Subject is free of any clinically significant disease that required a physician´s care and/or would interfere with trial evaluations, procedures or participation
- Subject is able to repeatedly and reliably perform PNIF measurements and must achieve PNIF value of >=60L/min at screening
- Subject must be capable of reading English and willing to participate in all aspects of the study
Who cannot join
- Any significant medical condition which, in the judgment of the investigator, is a contraindication to the use of loratadine, pseudoephedrine and fluticasone propionate, or might interfere with the trial. These may include subjects with injury or surgery to the nose that is not fully healed, fungal infections, immunocompromised conditions (HIV, tuberculosis), severe nosebleeds, narrow-angle glaucoma, chickenpox measles..., severe facial pain or thick nasal discharge, sinusitis, constant whistling sound from the nose, structured abnormality of the nose, uncontrolled thyroid disease (e.g., hyperthyroidism, hypothyroidism), uncontrolled diabetes mellitus, coronary heart disease ischemic heart disease, uncontrolled high blood pressure, symptomatic prostatic hypertrophy, bladder neck obstruction, hepatic insufficiency, renal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind Placebo-Controlled Crossover Study to Evaluate Objective Changes in Nasal Airflow of Loratadine/Pseudoephedrine Tablet and Fluticasone Propionate Nasal Spray in Subjects Following Allergen Exposure in an Environmental Exposure Unit
The purpose of the study is to evaluate changes in nasal airflow caused by loratadine 5 mg/pseudoephedrine sulfate 120 mg (Claritin D) tablet and fluticasone propionate 50 mcg per spray nasal spray (Flonase) in subjects suffering from nasal congestion and other allergy symptoms.
- Conditions
- Rhinitis, Allergic
- Being tested
- loratadine + pseudoephedrine sulfate (BAY818725/Claritin-D), Placebo tablet, Fluticasone Propionate, Placebo spray
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
loratadine + pseudoephedrine sulfate (BAY818725/Claritin-D)Drug
Single dose of Loratadine/pseudoephedrine in tablet 5 mg/120 mg orally
Placebo tabletDrug
Placebo tablet orally
Fluticasone PropionateDrug
Fluticasone Propionate Nasal Spray 50mcg per spray, 2 sprays per nostril
Placebo sprayDrug
Placebo Nasal Spray, 2 sprays per nostril
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Treatment phase will consist of four treatment visits separated by 14 (+/- 1) days between visits. Each treatment sequence consists of a single dose of each of the 4 treatments. Receives: Drug: loratadine + pseudoephedrine sulfate (BAY818725/Claritin-D); Drug: Placebo tablet; Drug: Fluticasone Propionate; Drug: Placebo spray |
| Sequence 2 | Experimental | Treatment phase will consist of four treatment visits separated by 14 (+/- 1) days between visits. Each treatment sequence consists of a single dose of each of the 4 treatments. Receives: Drug: loratadine + pseudoephedrine sulfate (BAY818725/Claritin-D); Drug: Placebo tablet; Drug: Fluticasone Propionate; Drug: Placebo spray |
| Sequence 3 | Experimental | Treatment phase will consist of four treatment visits separated by 14 (+/- 1) days between visits. Each treatment sequence consists of a single dose of treatment each of the 4 treatments. Receives: Drug: loratadine + pseudoephedrine sulfate (BAY818725/Claritin-D); Drug: Placebo tablet; Drug: Fluticasone Propionate; Drug: Placebo spray |
| Sequence 4 | Experimental | Treatment phase will consist of four treatment visits separated by 14 (+/- 1) days between visits. Each treatment sequence consists of a single dose of treatment each of the 4 treatments. Receives: Drug: loratadine + pseudoephedrine sulfate (BAY818725/Claritin-D); Drug: Placebo tablet; Drug: Fluticasone Propionate; Drug: Placebo spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average percent change in PNIF (Peak Nasal Inspiratory Flow) from 0 to 4 hours after dosing
Measured: 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 posted23 Feb 2018
- Study start21 Feb 2018
- Primary completion11 May 2018
- Study completion11 May 2018
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 Rhinitis, AllergicStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443843
- Sponsor's protocol ID
- 19880
- Status last verified
- Dec 2019
- First submitted
- 20 Feb 2018
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ng CC, Romaikin D, Steacy LM, Stevens DA, Walker TJ, Adams DE, Ellis AK. Comparative nasal airflow with loratadine-pseudoephedrine and fluticasone nasal spray for allergic rhinitis. Ann Allergy Asthma Immunol. 2021 Sep;127(3):342-348.e2. doi: 10.1016/j.anai.2021.05.001. Epub 2021 May 14.
PubMed 34000435
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Placebo-Controlled Crossover Study to Evaluate Objective Changes in Nasal Airflow of Loratadine/Pseudoephedrine Tablet and Fluticasone Propionate Nasal Spray in Subjects Following Allergen Exposure in an Environmental Exposure Unit
- ClinicalTrials.gov ID
- NCT03443843
- Acronym / sponsor ID
- 19880
- Conditions
- Rhinitis, Allergic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2018 (actual)
- Primary completion
- 11 May 2018 (actual)
- Study completion
- 11 May 2018 (actual)
- First posted
- 23 Feb 2018 (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 purpose of the study is to evaluate changes in nasal airflow caused by loratadine 5 mg/pseudoephedrine sulfate 120 mg (Claritin D) tablet and fluticasone propionate 50 mcg per spray nasal spray (Flonase) in subjects suffering from nasal congestion and other allergy symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: loratadine + pseudoephedrine sulfate (BAY818725/Claritin-D), Drug: Placebo tablet, Drug: Fluticasone Propionate, Drug: Placebo sprayTreatment phase will consist of four treatment visits separated by 14 (+/- 1) days between visits. Each treatment sequence consists of a single dose of each of the 4 treatments. |
| Sequence 2 | Experimental | Drug: loratadine + pseudoephedrine sulfate (BAY818725/Claritin-D), Drug: Placebo tablet, Drug: Fluticasone Propionate, Drug: Placebo sprayTreatment phase will consist of four treatment visits separated by 14 (+/- 1) days between visits. Each treatment sequence consists of a single dose of each of the 4 treatments. |
| Sequence 3 | Experimental | Drug: loratadine + pseudoephedrine sulfate (BAY818725/Claritin-D), Drug: Placebo tablet, Drug: Fluticasone Propionate, Drug: Placebo sprayTreatment phase will consist of four treatment visits separated by 14 (+/- 1) days between visits. Each treatment sequence consists of a single dose of treatment each of the 4 treatments. |
| Sequence 4 | Experimental | Drug: loratadine + pseudoephedrine sulfate (BAY818725/Claritin-D), Drug: Placebo tablet, Drug: Fluticasone Propionate, Drug: Placebo sprayTreatment phase will consist of four treatment visits separated by 14 (+/- 1) days between visits. Each treatment sequence consists of a single dose of treatment each of the 4 treatments. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy, ambulatory male and female subjects between 18 to 65 years of age
- Self-reported seasonal allergic rhinitis to ragweed pollen for at least 2 years prior to screening
- Documented positive skin prick test response to common ragweed (ambrosia artemisiifolia) pollen at screening or within the previous 12 months conducted at research site (prick with wheal diameter >= 5 mm larger than the diluent response)
- In order to qualify to continue to treatment phase, at the end of priming phase (which is 3 hours), Total Symptom Score (TSS) has to be ≥ 7, with nasal congestion score alone ≥ 2 and change in peak nasal inspiratory flow (PNIF) has to be ≥ 15% from pre-prime baseline;
- Subject is willing to stop use of current decongestant and allergy medications at the start of the washout period prior to priming and during the trial
Key exclusion criteria (1 listed)
- Any significant medical condition which, in the judgment of the investigator, is a contraindication to the use of loratadine, pseudoephedrine and fluticasone propionate, or might interfere with the trial. These may include subjects with injury or surgery to the nose that is not fully healed, fungal infections, immunocompromised conditions (HIV, tuberculosis), severe nosebleeds, narrow-angle glaucoma, chickenpox measles..., severe facial pain or thick nasal discharge, sinusitis, constant whistling sound from the nose, structured abnormality of the nose, uncontrolled thyroid disease (e.g., hyperthyroidism, hypothyroidism), uncontrolled diabetes mellitus, coronary heart disease ischemic heart disease, uncontrolled high blood pressure, symptomatic prostatic hypertrophy, bladder neck obstruction, hepatic insufficiency, renal disease
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 |
|---|---|---|
| loratadine + pseudoephedrine sulfate (BAY818725/Claritin-D)Single dose of Loratadine/pseudoephedrine in tablet 5 mg/120 mg orally | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| Placebo tabletPlacebo tablet orally | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| Fluticasone PropionateFluticasone Propionate Nasal Spray 50mcg per spray, 2 sprays per nostril | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| Placebo sprayPlacebo Nasal Spray, 2 sprays per nostril | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
Primary outcome
Average percent change in PNIF (Peak Nasal Inspiratory Flow) from 0 to 4 hours after dosing
Time frame: 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 20 Dec 2019.
- Derived from this study: PubMed 34000435Ng CC, Romaikin D, Steacy LM, Stevens DA, Walker TJ, Adams DE, Ellis AK. Comparative nasal airflow with loratadine-pseudoephedrine and fluticasone nasal spray for allergic rhinitis. Ann Allergy Asthma Immunol. 2021 Sep;127(3):342-348.e2. doi: 10.1016/j.anai.2021.05.001. Epub 2021 May 14.
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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 4 study testing loratadine + pseudoephedrine sulfate (BAY818725/Claritin-D) and Fluticasone Propionate in people with Rhinitis, Allergic, 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 9 inclusion and 1 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 20 Dec 2019. 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?
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?
Average percent change in PNIF (Peak Nasal Inspiratory Flow) from 0 to 4 hours after dosing (time frame: Up to 4 hours). 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 NCT03443843, 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 20 Dec 2019.