RhinitisPhase 2NCT01330017
Effects of Phenylephrine on Nasal Congestion in Participants With Seasonal Allergic Rhinitis (P08156 AM2)(Completed)
A Phase 2 study testing Phenylephrine HCl and Loratadine in people with Rhinitis and Seasonal Rhinitis, run by Bayer.
Trial summary
The trial will evaluate the nasal congestion symptom relief of the approved 10 mg phenylephrine (PE) dose and the higher 20 mg, 30 mg, and 40 mg PE doses compared with placebo in participants with histories of seasonal allergic rhinitis, using loratadine as background medication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhinitis, Seasonal Rhinitis
- What is being tested?
- Phenylephrine HCl and Loratadine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 539 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Jun 2011
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female participants of reproductive potential must have a negative pregnancy test and agree to use acceptable methods of birth control throughout the study.
- Participant is willing to stop use of current decongestant and allergy medications during the trial.
- Participant has a documented or self-reported history of seasonal allergy.
- Participant has documented positive skin testing to spring pollen allergens.
- Participant has nasal congestion of at least moderate severity.
- Participant has mean seated (after 5 minutes of rest) systolic/diastolic blood pressure ≤138/88 mmHg.
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- Participant has clinically acceptable physical exam and 12-lead electrocardiogram (ECG).
- Participant is without clinically significant disease.
- Participant must agree not to take monoamine oxidase inhibitor (MAOI) from 14 days before trial participation until 14 days after the end of the trial.
- Participant must sign an informed consent form
Who cannot join
- Participants must not have any significant medical condition that is a contraindication to the use of phenylephrine HCl or loratadine, such as thyroid disease, uncontrolled diabetes mellitus, coronary heart disease, ischemic heart disease, elevated intraocular pressure, or prostatic hypertrophy.
- Participants with a history or presence of hypertension.
- Participants who have started allergen immunotherapy within a month preceding enrollment or starting allergen immunotherapy or anticipating immunotherapy dose change during the trial. Xolair (omalizumab) may not be used within 4 years prior to trial participation.
- Participants who have a known allergy or intolerance to phenylephrine HCl, any other decongestant, loratadine, desloratadine, or any other antihistamine.
- Participants with persistent asthma, rhinitis medicamentosa, or acute or chronic sinusitis, or a history of significant sinusitis within one month of enrollment.
- Participant with a history of intermittent asthma may be considered for enrollment provided they have no asthma symptoms at the time of enrollment and use only a short acting beta2-agonist less than twice weekly.
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- Participants who have used systemic (oral, rectal, injectable), topical, or nasal corticosteroids in the last 30 days (up to 1% topical hydrocortisone is permitted).
- Participants using a leukotriene receptor antagonist for maintenance treatment of asthma.
- Participant with a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
- Participant with a history of immunological disease or malignancy within the past 5 years, with the exception of non-melanoma skin cancer.
- Participant with positive drug screen (participants on prescribed medication resulting in a positive drug screen result may still be enrolled at the discretion of the investigator).
- Participant has had major surgery or participated in another investigational study within 4 weeks prior to the Screening Visit.
- Participants taking any herbal supplements during trial conduct.
About this study
Official title: A Randomized, Dose-ranging, Placebo-controlled Trial to Evaluate the Effects of Phenylephrine HCl Immediate Release Tablets on Nasal Congestion in Subjects With Seasonal Allergic Rhinitis
The trial will evaluate the nasal congestion symptom relief of the approved 10 mg phenylephrine (PE) dose and the higher 20 mg, 30 mg, and 40 mg PE doses compared with placebo in participants with histories of seasonal allergic rhinitis, using loratadine as background medication.
- Conditions
- Rhinitis, Seasonal Rhinitis
- Being tested
- Phenylephrine HCl, Placebo, Loratadine
- Keywords
- Seasonal allergies
- Medical subject headings
- Rhinitis, Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phenylephrine HClDrug
Also called SCH 002063
10-mg immediate-release tablets, orally, up to 4 tablets per dose every 4 hours, for 7 days
PlaceboDrug
Placebo tablets, orally, up to five tablets per dose every 4 hours, for 7 days
LoratadineDrug
Also called Claritin®
10-mg tablets, orally, once per day at a dose not to exceed 10 mg in a 24-hour period.
| Study group | Role | What they receive |
|---|---|---|
| PE 10 mg | Experimental | Not described Receives: Drug: Phenylephrine HCl; Drug: Placebo; Drug: Loratadine |
| PE 20 mg | Experimental | Not described Receives: Drug: Phenylephrine HCl; Drug: Placebo; Drug: Loratadine |
| PE 30 mg | Experimental | Not described Receives: Drug: Phenylephrine HCl; Drug: Placebo; Drug: Loratadine |
| PE 40 mg | Experimental | Not described Receives: Drug: Phenylephrine HCl; Drug: Placebo; Drug: Loratadine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo; Drug: Loratadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline Over the Entire Treatment Period in the Daily Reflective Nasal Congestion Score
The reflective nasal congestion score was captured in participant diaries just before the 8:00 a.m. dose and 12 hours later just before the 8:00 p.m. dose. Participants rated congestion on a 4-point scale of severity from 0 (best) to 3 (worst), with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The daily reflective nasal congestion symptom score was defined as the average of the morning and evening reflective nasal congestion score for the entire treatment period. Baseline was defined as the average of the daily scores over the 4 consecutive 24-hour periods before randomization.
Measured: Baseline, Day 7
Secondary outcomes (7)
Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period
The morning reflective nasal congestion score was captured in participant diaries just before the 8:00 am dose. It is a composite score including four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and it is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms.
Measured: Baseline and Days 2, 3, 4, 5, 6, and 7
Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period
The evening reflective nasal congestion score was captured in participant diaries just before the 8;00 p.m. dose. It is a composite score including four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms.
Measured: Baseline and Days 1, 2, 3, 4, 5, 6, and 7
Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period
Instantaneous assessment of nasal symptoms was performed once daily before the
morning dose. The instantaneous assessment was a composite score of four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms.
Measured: Baseline and Day 2, 3, 4, 5, 6, and 7
Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period
The reflective nasal congestion score was captured in participant diaries just before the 8:00 a.m. dose and 12 hours later just before the 8:00 p.m. dose. It is a composite score including four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The daily reflective nasal congestion symptom score was defined as the average of the morning and evening reflective nasal congestion score for the entire treatment period.
Measured: Baseline and Days 1, 2, 3, 4, 5, 6, and 7
Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period
Instantaneous assessment of nasal symptoms was performed once daily before the
morning dose. The instantaneous assessment was a composite score of four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms.
Measured: Baseline and Days 1, 2, 3, 4, 5, 6, and 7
Time to Maximal Effect
Time to maximal effect is defined as the earliest time that the nasal congestion symptom score demonstrates the greatest numerical difference from the placebo in change from baseline. The mean change from baseline scores for a treatment arm and for the placebo arm at each day and timepoint of the treatment period (Day 1 morn, Day 1 eve, etc) were calculated. Then the difference between the placebo and treatment arm means at each day/timepoint of the treatment period was calculated and recorded the day/timepoint that the difference between the treatment arm and the placebo was highest.
Measured: Baseline up to Day 7
Change From Baseline for the Instantaneous Nasal Symptom Assessment Score at Day 7
The magnitude of effect was measured as the change from baseline for the instantaneous nasal symptom assessment score at Day 7. Instantaneous assessment of nasal symptoms was performed once daily before the morning dose. The instantaneous assessment was a composite score of four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms.
Measured: Baseline, Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2011
- Study completionJun 2011
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 539 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330017
- Sponsor's protocol ID
- 18123
- Other IDs
- CL2010-06, P08156
- Status last verified
- Feb 2015
- First submitted
- 4 Apr 2011
- Last updated
- 11 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Meltzer EO, Ratner PH, McGraw T. Oral Phenylephrine HCl for Nasal Congestion in Seasonal Allergic Rhinitis: A Randomized, Open-label, Placebo-controlled Study. J Allergy Clin Immunol Pract. 2015 Sep-Oct;3(5):702-8. doi: 10.1016/j.jaip.2015.05.007. Epub 2015 Jul 2.
PubMed 26143019
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Dose-ranging, Placebo-controlled Trial to Evaluate the Effects of Phenylephrine HCl Immediate Release Tablets on Nasal Congestion in Subjects With Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT01330017
- Acronym / sponsor ID
- 18123
- Conditions
- Rhinitis, Seasonal Rhinitis
- Keywords
- Seasonal allergies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 539 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 6 Apr 2011 (estimated)
- Results
- Posted 7 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trial will evaluate the nasal congestion symptom relief of the approved 10 mg phenylephrine (PE) dose and the higher 20 mg, 30 mg, and 40 mg PE doses compared with placebo in participants with histories of seasonal allergic rhinitis, using loratadine as background medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| PE 10 mg | Experimental | Drug: Phenylephrine HCl, Drug: Placebo, Drug: Loratadine |
| PE 20 mg | Experimental | Drug: Phenylephrine HCl, Drug: Placebo, Drug: Loratadine |
| PE 30 mg | Experimental | Drug: Phenylephrine HCl, Drug: Placebo, Drug: Loratadine |
| PE 40 mg | Experimental | Drug: Phenylephrine HCl, Drug: Placebo, Drug: Loratadine |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Loratadine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Female participants of reproductive potential must have a negative pregnancy test and agree to use acceptable methods of birth control throughout the study.
- Participant is willing to stop use of current decongestant and allergy medications during the trial.
- Participant has a documented or self-reported history of seasonal allergy.
- Participant has documented positive skin testing to spring pollen allergens.
- Participant has nasal congestion of at least moderate severity.
Key exclusion criteria (13 listed)
- Participants must not have any significant medical condition that is a contraindication to the use of phenylephrine HCl or loratadine, such as thyroid disease, uncontrolled diabetes mellitus, coronary heart disease, ischemic heart disease, elevated intraocular pressure, or prostatic hypertrophy.
- Participants with a history or presence of hypertension.
- Participants who have started allergen immunotherapy within a month preceding enrollment or starting allergen immunotherapy or anticipating immunotherapy dose change during the trial. Xolair (omalizumab) may not be used within 4 years prior to trial participation.
- Participants who have a known allergy or intolerance to phenylephrine HCl, any other decongestant, loratadine, desloratadine, or any other antihistamine.
- Participants with persistent asthma, rhinitis medicamentosa, or acute or chronic sinusitis, or a history of significant sinusitis within one month of enrollment.
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 HClAlso: SCH 00206310-mg immediate-release tablets, orally, up to 4 tablets per dose every 4 hours, for 7 days | Drug | PE 10 mg, PE 20 mg, PE 30 mg, PE 40 mg |
| PlaceboPlacebo tablets, orally, up to five tablets per dose every 4 hours, for 7 days | Drug | PE 10 mg, PE 20 mg, PE 30 mg, PE 40 mg, Placebo |
| LoratadineAlso: Claritin®10-mg tablets, orally, once per day at a dose not to exceed 10 mg in a 24-hour period. | Drug | PE 10 mg, PE 20 mg, PE 30 mg, PE 40 mg, Placebo |
Primary outcome
Mean Change From Baseline Over the Entire Treatment Period in the Daily Reflective Nasal Congestion Score
Time frame: Baseline, Day 7
The reflective nasal congestion score was captured in participant diaries just before the 8:00 a.m. dose and 12 hours later just before the 8:00 p.m. dose. Participants rated congestion on a 4-point scale of severity from 0 (best) to 3 (worst), with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The daily reflective nasal congestion symptom score was defined as the average of the morning and evening reflective nasal congestion score for the entire treatment period. Baseline was defined as the average of the daily scores over the 4 consecutive 24-hour periods before randomization.
7 secondary outcomes
Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period
Time frame: Baseline and Days 2, 3, 4, 5, 6, and 7
Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period
Time frame: Baseline and Days 1, 2, 3, 4, 5, 6, and 7
Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period
Time frame: Baseline and Day 2, 3, 4, 5, 6, and 7
Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period
Time frame: Baseline and Days 1, 2, 3, 4, 5, 6, and 7
Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period
Time frame: Baseline and Days 1, 2, 3, 4, 5, 6, and 7
Time to Maximal Effect
Time frame: Baseline up to Day 7
Change From Baseline for the Instantaneous Nasal Symptom Assessment Score at Day 7
Time frame: Baseline, Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26143019Meltzer EO, Ratner PH, McGraw T. Oral Phenylephrine HCl for Nasal Congestion in Seasonal Allergic Rhinitis: A Randomized, Open-label, Placebo-controlled Study. J Allergy Clin Immunol Pract. 2015 Sep-Oct;3(5):702-8. doi: 10.1016/j.jaip.2015.05.007. Epub 2015 Jul 2.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Phenylephrine HCl and Loratadine in people with Rhinitis and Seasonal Rhinitis, run by Bayer.
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 13 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 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 7 Nov 2012). 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?
Mean Change From Baseline Over the Entire Treatment Period in the Daily Reflective Nasal Congestion Score (time frame: Baseline, Day 7). 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 NCT01330017, 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 11 Mar 2015.