Rhinitis, Allergic, SeasonalPhase 3NCT00276016
The Effects of Phenylephrine Compared With Those of Placebo and Pseudoephedrine on Nasal Congestion in Subjects With Seasonal Allergic Rhinitis (SAR)(P04579)
A Phase 3 study testing phenylephrine and pseudoephedrine in people with Rhinitis, Allergic, Seasonal, run by Organon and Co.
Trial summary
This is a Phase 3, single-dose, investigator-blind, randomized, placebo-controlled, crossover study, conducted at a single site in Austria, outside of the normal grass pollen season. An allergic reaction will be induced by exposing subjects to grass pollen in the Vienna Challenge Chamber (VCC). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Rhinitis, Allergic, Seasonal
- What is being tested?
- phenylephrine and pseudoephedrine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Feb 2006
- Phase
- Phase 3
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Skin test positive for the grass pollen allergen used in the chamber at Screening or within the prior 12 months.
- A negative urine pregnancy test at Screening and at monthly intervals for female subjects of childbearing potential.
- The following minimum scores at an evaluation time point during each of the 120-minute screening period challenge sessions:
- Nasal Congestion Score of at least 2 (moderate);
- Total Nasal Symptoms Score of at least 6;
- Total Non-nasal Symptoms Score of at least 2.
- Freedom from any clinically significant disease, other than SAR, that would interfere with the study evaluations.
Who cannot join
- An upper or lower respiratory tract infection within 4 weeks before Screening.
- Dependence upon nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids, in the opinion of the investigator.
- A known potential for hypersensitivity, allergy, or idiosyncratic reaction to the study drug or excipients.
About this study
Official title: Crossover Study of the Decongestant Effect of Phenylephrine Compared With Placebo and Pseudoephedrine as Active Control in SAR Subjects Exposed to Pollen in the Vienna Challenge Chamber
This is a Phase 3, single-dose, investigator-blind, randomized, placebo-controlled, crossover study, conducted at a single site in Austria, outside of the normal grass pollen season. An allergic reaction will be induced by exposing subjects to grass pollen in the Vienna Challenge Chamber (VCC). Subjects will receive a single dose of each of the following treatments according to a randomization sequence: Phenylephrine 12 mg immediate-release capsule, pseudoephedrine 60 mg immediate-release tablet, and placebo capsule. There will be a minimum of a 5-day washout period between each treatment. Subjects will complete symptom evaluations throughout the study. The nasal decongestant effects of phenylephrine will be compared to those of placebo using the subjective symptom evaluations. The safety profile (adverse events and vital signs) of the treatments will also be evaluated.
- Conditions
- Rhinitis, Allergic, Seasonal
- Being tested
- phenylephrine, pseudoephedrine, placebo
- 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.
phenylephrineDrug
immediate-release 12 mg capsules for oral administration
pseudoephedrineDrug
60 mg immediate-release tablets for oral administration
placeboDrug
placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| Phenylephrine, Pseudoephedrine, Placebo | Experimental | Phenylephrine: Immediate-release 12 mg capsules for oral administration.
Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
Placebo: Placebo capsules. Receives: Drug: phenylephrine; Drug: pseudoephedrine; Drug: placebo |
| Pseudoephedrine, Placebo, Phenylephrine | Experimental | Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
Placebo: Placebo capsules.
Phenylephrine: Immediate-release 12 mg capsules for oral administration. Receives: Drug: phenylephrine; Drug: pseudoephedrine; Drug: placebo |
| Placebo, Phenylephrine, Pseudoephedrine | Experimental | Placebo: Placebo capsules.
Phenylephrine: Immediate-release 12 mg capsules for oral administration.
Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Receives: Drug: phenylephrine; Drug: pseudoephedrine; Drug: placebo |
| Phenylephrine, Placebo, Pseudoephedrine | Experimental | Phenylephrine: Immediate-release 12 mg capsules for oral administration.
Placebo: Placebo capsules.
Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Receives: Drug: phenylephrine; Drug: pseudoephedrine; Drug: placebo |
| Pseudoephedrine, Phenylephrine, Placebo | Experimental | Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
Phenylephrine: Immediate-release 12 mg capsules for oral administration.
Placebo: Placebo capsules. Receives: Drug: phenylephrine; Drug: pseudoephedrine; Drug: placebo |
| Placebo, Pseudoephedrine, Phenylephrine | Experimental | Placebo: Placebo capsules.
Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
Phenylephrine: Immediate-release 12 mg capsules for oral administration. Receives: Drug: phenylephrine; Drug: pseudoephedrine; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Phenylephrine Compared With Placebo
To evaluate the effect of phenylephrine 12-mg immediate-release capsule on nasal congestion in subjects with seasonal allergic rhinitis (SAR) who have been exposed to pollen for 6 hours in the Vienna Challenge Chamber (VCC). The average change from the Baseline was evaluated immediately before treatment start, over the first 6 hour post-dosing.
The values for the scale are 0,1,2,3 for measure of symptoms, defined as 0-none, 1-mild, 2-moderate, 3-severe. They are subject-evaluated results.
Measured: Baseline to endpoint (6 hour period)
Secondary outcomes (1)
The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Pseudoephedrine and Placebo.
To estimate the effect of a pseudoephedrine (PSE) 60 mg immediate release tablet on nasal congestion over a 6-hour observation period relative to placebo
The values for the nasal congestion score scale are 0,1,2,3 for measure of symptoms, defined as 0-none, 1-mild, 2-moderate, 3-severe. They are subject-evaluated results.
Measured: Baseline to endpoint (6 hour period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2006 (estimated)
- Study startJan 2006
- Primary completionFeb 2006
- Study completionFeb 2006
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 Rhinitis, Allergic, SeasonalStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00276016
- Sponsor's protocol ID
- P04579
- Status last verified
- Feb 2022
- First submitted
- 11 Jan 2006
- Last updated
- 9 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Horak F, Zieglmayer P, Zieglmayer R, Lemell P, Yao R, Staudinger H, Danzig M. A placebo-controlled study of the nasal decongestant effect of phenylephrine and pseudoephedrine in the Vienna Challenge Chamber. Ann Allergy Asthma Immunol. 2009 Feb;102(2):116-20. doi: 10.1016/S1081-1206(10)60240-2.
PubMed 19230461
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crossover Study of the Decongestant Effect of Phenylephrine Compared With Placebo and Pseudoephedrine as Active Control in SAR Subjects Exposed to Pollen in the Vienna Challenge Chamber
- ClinicalTrials.gov ID
- NCT00276016
- Acronym / sponsor ID
- P04579
- Conditions
- Rhinitis, Allergic, Seasonal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 12 Jan 2006 (estimated)
- Results
- Posted 29 Jul 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 3, single-dose, investigator-blind, randomized, placebo-controlled, crossover study, conducted at a single site in Austria, outside of the normal grass pollen season. An allergic reaction will be induced by exposing subjects to grass pollen in the Vienna Challenge Chamber (VCC). Subjects will receive a single dose of each of the following treatments according to a randomization sequence: Phenylephrine 12 mg immediate-release capsule, pseudoephedrine 60 mg immediate-release tablet, and placebo capsule. There will be a minimum of a 5-day washout period between each treatment. Subjects will complete symptom evaluations throughout the study. The nasal decongestant effects of phenylephrine will be compared to those of placebo using the subjective symptom evaluations. The safety profile (adverse events and vital signs) of the treatments will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Phenylephrine, Pseudoephedrine, Placebo | Experimental | Drug: phenylephrine, Drug: pseudoephedrine, Drug: placeboPhenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules. |
| Pseudoephedrine, Placebo, Phenylephrine | Experimental | Drug: phenylephrine, Drug: pseudoephedrine, Drug: placeboPseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration. |
| Placebo, Phenylephrine, Pseudoephedrine | Experimental | Drug: phenylephrine, Drug: pseudoephedrine, Drug: placeboPlacebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. |
| Phenylephrine, Placebo, Pseudoephedrine | Experimental | Drug: phenylephrine, Drug: pseudoephedrine, Drug: placeboPhenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. |
| Pseudoephedrine, Phenylephrine, Placebo | Experimental | Drug: phenylephrine, Drug: pseudoephedrine, Drug: placeboPseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules. |
| Placebo, Pseudoephedrine, Phenylephrine | Experimental | Drug: phenylephrine, Drug: pseudoephedrine, Drug: placeboPlacebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Skin test positive for the grass pollen allergen used in the chamber at Screening or within the prior 12 months.
- A negative urine pregnancy test at Screening and at monthly intervals for female subjects of childbearing potential.
- The following minimum scores at an evaluation time point during each of the 120-minute screening period challenge sessions:
- Freedom from any clinically significant disease, other than SAR, that would interfere with the study evaluations.
Key exclusion criteria (3 listed)
- An upper or lower respiratory tract infection within 4 weeks before Screening.
- Dependence upon nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids, in the opinion of the investigator.
- A known potential for hypersensitivity, allergy, or idiosyncratic reaction to the study drug or excipients.
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 |
|---|---|---|
| phenylephrineimmediate-release 12 mg capsules for oral administration | Drug | Phenylephrine, Placebo, Pseudoephedrine, Phenylephrine, Pseudoephedrine, Placebo, Placebo, Phenylephrine, Pseudoephedrine, Placebo, Pseudoephedrine, Phenylephrine, Pseudoephedrine, Phenylephrine, Placebo, Pseudoephedrine, Placebo, Phenylephrine |
| pseudoephedrine60 mg immediate-release tablets for oral administration | Drug | Phenylephrine, Placebo, Pseudoephedrine, Phenylephrine, Pseudoephedrine, Placebo, Placebo, Phenylephrine, Pseudoephedrine, Placebo, Pseudoephedrine, Phenylephrine, Pseudoephedrine, Phenylephrine, Placebo, Pseudoephedrine, Placebo, Phenylephrine |
| placeboplacebo capsules | Drug | Phenylephrine, Placebo, Pseudoephedrine, Phenylephrine, Pseudoephedrine, Placebo, Placebo, Phenylephrine, Pseudoephedrine, Placebo, Pseudoephedrine, Phenylephrine, Pseudoephedrine, Phenylephrine, Placebo, Pseudoephedrine, Placebo, Phenylephrine |
Primary outcome
The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Phenylephrine Compared With Placebo
Time frame: Baseline to endpoint (6 hour period)
To evaluate the effect of phenylephrine 12-mg immediate-release capsule on nasal congestion in subjects with seasonal allergic rhinitis (SAR) who have been exposed to pollen for 6 hours in the Vienna Challenge Chamber (VCC). The average change from the Baseline was evaluated immediately before treatment start, over the first 6 hour post-dosing. The values for the scale are 0,1,2,3 for measure of symptoms, defined as 0-none, 1-mild, 2-moderate, 3-severe. They are subject-evaluated results.
1 secondary outcome
The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Pseudoephedrine and Placebo.
Time frame: Baseline to endpoint (6 hour period)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 19230461Horak F, Zieglmayer P, Zieglmayer R, Lemell P, Yao R, Staudinger H, Danzig M. A placebo-controlled study of the nasal decongestant effect of phenylephrine and pseudoephedrine in the Vienna Challenge Chamber. Ann Allergy Asthma Immunol. 2009 Feb;102(2):116-20. doi: 10.1016/S1081-1206(10)60240-2.
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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 3 study testing phenylephrine and pseudoephedrine in people with Rhinitis, Allergic, Seasonal, run by Organon and Co.
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 7 inclusion and 3 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 9 Feb 2022. 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. 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?
Yes. Results are posted in the registry (first posted 29 Jul 2010). 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?
The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Phenylephrine Compared With Placebo (time frame: Baseline to endpoint (6 hour period)). 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 NCT00276016, 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 9 Feb 2022.