Rhinitis, Allergic, Seasonal
Conditions
Brief 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). 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.
Interventions
DRUGphenylephrine
immediate-release 12 mg capsules for oral administration
DRUGpseudoephedrine
60 mg immediate-release tablets for oral administration
DRUGplacebo
placebo capsules
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* 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: 1. Nasal Congestion Score of at least 2 (moderate); 2. Total Nasal Symptoms Score of at least 6; 3. 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.
Exclusion criteria
: * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Phenylephrine Compared With Placebo | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Pseudoephedrine and Placebo. | Baseline to endpoint (6 hour period) | 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. |
Participant flow
Pre-assignment details
1 subject discontinued for reasons unrelated to treatment with study drug after the first dose (Intervention 1) of study drug Pseudoephedrine(PSE)
Participants by arm
| Arm | Count |
|---|---|
| Phenylephrine, Pseudoephedrine, Placebo Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules | 7 |
| Pseudoephedrine, Placebo, Phenylephrine Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration. | 7 |
| Placebo, Phenylephrine, Pseudoephedrine Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. | 7 |
| Phenylephrine, Placebo, Pseudoephedrine Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. | 6 |
| Pseudoephedrine, Phenylephrine, Placebo Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release
12 mg capsules for oral administration. Placebo: Placebo capsules. | 6 |
| Placebo, Pseudoephedrine, Phenylephrine Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration | 6 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Intervention 1 | Withdrawal by Subject | 0 | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Phenylephrine, Pseudoephedrine, Placebo | Pseudoephedrine, Placebo, Phenylephrine | Placebo, Phenylephrine, Pseudoephedrine | Phenylephrine, Placebo, Pseudoephedrine | Pseudoephedrine, Phenylephrine, Placebo | Placebo, Pseudoephedrine, Phenylephrine | Total |
|---|---|---|---|---|---|---|---|
| Age, Customized | 27.9 years STANDARD_DEVIATION 9 | 27.9 years STANDARD_DEVIATION 3.3 | 24.9 years STANDARD_DEVIATION 3.5 | 26.3 years STANDARD_DEVIATION 1.6 | 28.0 years STANDARD_DEVIATION 7.1 | 27.3 years STANDARD_DEVIATION 3.3 | 27.0 years STANDARD_DEVIATION 5.1 |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 4 Participants | 1 Participants | 3 Participants | 5 Participants | 23 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 3 Participants | 5 Participants | 3 Participants | 1 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 39 | 0 / 39 | 0 / 39 |
| serious Total, serious adverse events | 0 / 39 | 0 / 39 | 0 / 39 |
Outcome results
Primary
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.
Time frame: Baseline to endpoint (6 hour period)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Phenylephrine Compared With Placebo | Baseline score | 2.20 Units on a scale | Standard Deviation 0.36 |
| Placebo | The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Phenylephrine Compared With Placebo | Change from Baseline to Endpoint Score | -0.12 Units on a scale | Standard Deviation 0.44 |
| Phenylephrine | The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Phenylephrine Compared With Placebo | Baseline score | 2.20 Units on a scale | Standard Deviation 0.36 |
| Phenylephrine | The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Phenylephrine Compared With Placebo | Change from Baseline to Endpoint Score | -0.18 Units on a scale | Standard Deviation 0.44 |
Comparison: For endpointp-value: 0.561ANOVA
Secondary
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.
Time frame: Baseline to endpoint (6 hour period)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Pseudoephedrine and Placebo. | Baseline | 2.26 Units on a scale | Standard Deviation 0.36 |
| Placebo | The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Pseudoephedrine and Placebo. | Endpoint | -0.47 Units on a scale | Standard Deviation 0.44 |
| Phenylephrine | The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Pseudoephedrine and Placebo. | Endpoint | -0.12 Units on a scale | Standard Deviation 0.44 |
| Phenylephrine | The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Pseudoephedrine and Placebo. | Baseline | 2.20 Units on a scale | Standard Deviation 0.36 |
Comparison: For endpointp-value: <0.001ANOVA