Nasal Congestion Due to Allergic RhinitisPhase 3NCT04534452
Study to Find Out Whether Participants With a History of Stuffy Nose Due to Allergic Reactions in the Nose Would Intend to Buy Drug Phenylephrine Hydrochloride Extended Release Tablets After Receiving it Once in This Study
A Phase 3 study testing Phenylephrine HCl (Sinus Comfort, BAY112476) in people with Nasal Congestion Due to Allergic Rhinitis, run by Bayer at 1 site in United States.
Trial summary
The researchers in this study want to find out whether participants with a history of stuffy nose due to allergic reactions in the nose would intend to buy drug Phenylephrine Hydrochloride (Phenylephrine HCl) extended release tablet (a pill is formulated so that the drug is released slowly over time) after receiving… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Nasal Congestion Due to Allergic Rhinitis
- What is being tested?
- Phenylephrine HCl (Sinus Comfort, BAY112476)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 347 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2012to 6 Jun 2012
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy male or female volunteers must be 18 to 60 years old.
- Subjects must currently use or have previously used oral decongestant products.
- Subjects must have a documented and/or self-reported history (of at least 2 years) of allergic rhinitis with nasal congestion.
- Subjects must be willing to stop use of current decongestant and allergy medications during the study, and for the number of wash-out days required for their medication prior to the run-in period.
- Subjects must have nasal congestion due to allergic rhinitis of at least mild severity (sign/symptom clearly present, but minimal awareness; easily tolerated) at Visits 1 and 2.
- Subjects must have a mean seated (after 5 minutes of rest) systolic/diastolic blood pressure ≤ 138/88 mmHg.
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- Subjects must have normal or clinically acceptable physical exam.
- Subjects must agree not to take monoamine oxidase inhibitor (MAOI) for 14 days before study participation and 14 days after the end of the study.
- Subjects must be willing to give written informed consent (prior to any study related procedures being performed) and able to adhere to restrictions and examination schedules.
- Female subjects of childbearing potential (a non-menopausal female who has not had a hysterectomy, bilateral oophorectomy, or medically documented ovarian failure, including a young woman who has not yet started menstruating) must be using medically acceptable (documented failure rate of less than 1%) birth control measures. Examples of medically acceptable contraception include hormonal contraceptives, intrauterine device (IUD), double-barrier method (any combination of male or female condom, diaphragm, spermicidal gel, sponge) or sterilization.
Who cannot join
- Subjects must not have any significant medical condition which, in the judgment of the investigator, is a contraindication to the use of phenylephrine HCl, might interfere with the study or requires treatment expected to affect the blood pressure. These may include thyroid disease (e.g. hyperthyroidism, hypothyroidism), uncontrolled diabetes mellitus, coronary heart disease, ischemic heart disease, elevated intraocular pressure, prostatic hypertrophy, etc.
- Subjects that have received allergen immunotherapy (if less than 3 months of stable dosing prior to screening) or Xolair (omalizumab) therapy within the past two years.
- Subjects who have a history of any clinically significant local or systemic infectious disease within four weeks prior to treatment administration.
- Subjects who have participated in a clinical trial of an investigational treatment within 30 days prior to the start of the study.
- Subjects who are, appear to be, or are known to be, current or former addicts or alcoholics.
- Subjects who have a known allergy or intolerance to phenylephrine HCl or any other decongestant, or any antihistamine.
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- Females who are pregnant, nursing or unwilling to use/practice medically acceptable contraception (documented failure rate of less than 1%).
- Subjects who have used a nasal decongestant or phenylephrine-containing product other than study medication after the start of the study and during the washout period.
- Subjects with a history of asthma, rhinitis medicamentosa, or presenting with acute or chronic sinusitis.
- Subjects that have used inhaled, oral, rectal, topical (intranasal corticosteroids for allergic rhinitis are permitted), intramuscular, and/or intravenous chronic or intermittent corticosteroids (up to 1% topical hydrocortisone is permitted).
- Subject who have family or who currently or previously have been employed in the pharmaceutical industry.
Trial locations and contacts
1 site in 1 country.
United States1 site
Allergy & Asthma Specialists, PC
Blue Bell, Pennsylvania, 19422
About this study
Official title: A Multicenter, Consumer Product Evaluation of a Single Dose of Phenylephrine Hydrochloride 30 mg Extended Release Tablets (Sinus Comfort™)
The researchers in this study want to find out whether participants with a history of stuffy nose due to allergic reactions in the nose would intend to buy drug Phenylephrine Hydrochloride (Phenylephrine HCl) extended release tablet (a pill is formulated so that the drug is released slowly over time) after receiving it once in this study. Phenylephrine HCl is an over-the-counter (OTC) drug (a medicine that can be bought without a prescription) used to provide temporary relief of stuffy nose caused by cold or allergies in mouth, nose and throat. Phenylephrine HCl immediate-release tablet (a pill with drug released rapidly without special rate controlling) was already approved to be used for adults and children and the recommended dose for adults and children 12 years or older is 10mg every 4 hours. Phenylephrine HCl 30mg extended release tablet used in this study is not yet approved but under development with a goal to relieve stuffy nose for every 8 hours. Researchers also want to find out if participants have any medical problems during the trial.
Participants in this study will be asked to record their stuffy nose symptoms in a diary before and after drug intake. At 8 hours after drug intake, participants need to assess whether they intends to buy the drug or not and their overall satisfaction of the stuffy nose relief. At the end the participants will complete a questionnaire about their job, learning background, income and medical history of stuffy nose.
- Being tested
- Phenylephrine HCl (Sinus Comfort, BAY112476)
- Keywords
- Allergic Rhinitis with Nasal congestion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phenylephrine HCl (Sinus Comfort, BAY112476)Drug
30 mg Extended Release Tablets, single oral dose
| Study group | Role | What they receive |
|---|---|---|
| Phenylephrine HCl | Experimental | Subjects have a documented and/or self-reported history of allergic rhinitis with nasal congestion for at least 2 years. Receives: Drug: Phenylephrine HCl (Sinus Comfort, BAY112476) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Purchase intent evaluated by using the 5-point scale
- 4 = Very Acceptable
- 3 = Acceptable
- 2 = Somewhat acceptable
- 1 = Somewhat unacceptable
- 0 = Very unacceptable
Measured: At approximately 8 hours postdose
Secondary outcomes (1)
Overall satisfaction for nasal congestion relief evaluated by using the 5-point scale
- 4 = Very Acceptable
- 3 = Acceptable
- 2 = Somewhat acceptable
- 1 = Somewhat unacceptable
- 0 = Very unacceptable
Measured: At approximately 8 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start12 May 2012
- Primary completion6 Jun 2012
- Study completion6 Jun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal Congestion Due to 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04534452
- Sponsor's protocol ID
- 18146
- Status last verified
- Aug 2020
- First submitted
- 27 Aug 2020
- Last updated
- 1 Sep 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Consumer Product Evaluation of a Single Dose of Phenylephrine Hydrochloride 30 mg Extended Release Tablets (Sinus Comfort™)
- ClinicalTrials.gov ID
- NCT04534452
- Acronym / sponsor ID
- 18146
- Keywords
- Allergic Rhinitis with Nasal congestion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 12 May 2012 (actual)
- Primary completion
- 6 Jun 2012 (actual)
- Study completion
- 6 Jun 2012 (actual)
- First posted
- 1 Sep 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.
The researchers in this study want to find out whether participants with a history of stuffy nose due to allergic reactions in the nose would intend to buy drug Phenylephrine Hydrochloride (Phenylephrine HCl) extended release tablet (a pill is formulated so that the drug is released slowly over time) after receiving it once in this study. Phenylephrine HCl is an over-the-counter (OTC) drug (a medicine that can be bought without a prescription) used to provide temporary relief of stuffy nose caused by cold or allergies in mouth, nose and throat. Phenylephrine HCl immediate-release tablet (a pill with drug released rapidly without special rate controlling) was already approved to be used for adults and children and the recommended dose for adults and children 12 years or older is 10mg every 4 hours. Phenylephrine HCl 30mg extended release tablet used in this study is not yet approved but under development with a goal to relieve stuffy nose for every 8 hours. Researchers also want to find out if participants have any medical problems during the trial.
Participants in this study will be asked to record their stuffy nose symptoms in a diary before and after drug intake. At 8 hours after drug intake, participants need to assess whether they intends to buy the drug or not and their overall satisfaction of the stuffy nose relief. At the end the participants will complete a questionnaire about their job, learning background, income and medical history of stuffy nose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phenylephrine HCl | Experimental | Drug: Phenylephrine HCl (Sinus Comfort, BAY112476)Subjects have a documented and/or self-reported history of allergic rhinitis with nasal congestion for at least 2 years. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy male or female volunteers must be 18 to 60 years old.
- Subjects must currently use or have previously used oral decongestant products.
- Subjects must have a documented and/or self-reported history (of at least 2 years) of allergic rhinitis with nasal congestion.
- Subjects must be willing to stop use of current decongestant and allergy medications during the study, and for the number of wash-out days required for their medication prior to the run-in period.
- Subjects must have nasal congestion due to allergic rhinitis of at least mild severity (sign/symptom clearly present, but minimal awareness; easily tolerated) at Visits 1 and 2.
Key exclusion criteria (11 listed)
- Subjects must not have any significant medical condition which, in the judgment of the investigator, is a contraindication to the use of phenylephrine HCl, might interfere with the study or requires treatment expected to affect the blood pressure. These may include thyroid disease (e.g. hyperthyroidism, hypothyroidism), uncontrolled diabetes mellitus, coronary heart disease, ischemic heart disease, elevated intraocular pressure, prostatic hypertrophy, etc.
- Subjects that have received allergen immunotherapy (if less than 3 months of stable dosing prior to screening) or Xolair (omalizumab) therapy within the past two years.
- Subjects who have a history of any clinically significant local or systemic infectious disease within four weeks prior to treatment administration.
- Subjects who have participated in a clinical trial of an investigational treatment within 30 days prior to the start of the study.
- Subjects who are, appear to be, or are known to be, current or former addicts or alcoholics.
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 |
|---|---|---|
| Phenylephrine HCl (Sinus Comfort, BAY112476)30 mg Extended Release Tablets, single oral dose | Drug | Phenylephrine HCl |
Primary outcome
Purchase intent evaluated by using the 5-point scale
Time frame: At approximately 8 hours postdose
* 4 = Very Acceptable * 3 = Acceptable * 2 = Somewhat acceptable * 1 = Somewhat unacceptable * 0 = Very unacceptable
1 secondary outcome
Overall satisfaction for nasal congestion relief evaluated by using the 5-point scale
Time frame: At approximately 8 hours postdose
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 1 Sep 2020.
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.
Bayer Study Director study director
Bayer
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 Phenylephrine HCl (Sinus Comfort, BAY112476) in people with Nasal Congestion Due to Allergic Rhinitis, run by Bayer at 1 site in United States.
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 10 inclusion and 11 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 1 Sep 2020. 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 United States. 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?
Purchase intent evaluated by using the 5-point scale (time frame: At approximately 8 hours postdose). 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 1 Sep 2020.