Trial Outcomes & Findings for A Study of the Effects of Single Dose Corticosteroids on Response to Allergens (NCT NCT00828061)

Last Updated: 2019-04-02

Results Overview

Comparison of the Change in Allergen-induced Interleukin 5 (IL-5) as Measured in Nasal Exudates After a Single Dose of Low or High Dose of Oral Prednisone Relative to Placebo

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

19 participants

Primary outcome timeframe

Baseline and Hour 8 post nasal allergen challenge

Results posted on

2019-04-02

Participant Flow

First Patient Entered: 04-Feb-2009 Last Patient, Last Visit: 21-May-2009 2 sites

Participant milestones

Participant milestones
Measure	Placebo / Prednisone / Prednisone 1 day placebo, 1 day 10 mg prednisone, 1 day 25 mg prednisone	Prednisone / Prednisone / Placebo 1 day 10 mg prednisone, 1 day 25 mg prednisone, 1 day placebo	Prednisone / Placebo / Prednisone 1 day 25 mg prednisone, 1 day placebo, 1 day 10 mg prednisone	Placebo / Prednisone / Prednisone 1 day placebo, 1 day 25 mg prednisone, 1 day 10 mg prednisone	Prednisone / Placebo / Prednisone 1 day 10 mg prednisone, 1 day placebo, 1 day 25 mg prednisone	Prednisone / Prednisone / Placebo 1 day 25 mg prednisone, 1 day 10 mg prednisone, 1 day placebo
Period 1 STARTED	4	3	3	3	3	3
Period 1 COMPLETED	4	3	3	3	3	3
Period 1 NOT COMPLETED	0	0	0	0	0	0
Period 2 STARTED	4	3	3	3	3	3
Period 2 COMPLETED	4	3	3	3	3	3
Period 2 NOT COMPLETED	0	0	0	0	0	0
Period 3 STARTED	4	3	3	3	3	3
Period 3 COMPLETED	4	3	3	3	3	3
Period 3 NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of the Effects of Single Dose Corticosteroids on Response to Allergens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Patients n=19 Participants All patients who completed at least one period are included in the analysis
Age, Continuous	40.4 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Hour 8 post nasal allergen challenge

Population: All Patients as Treated

Comparison of the Change in Allergen-induced Interleukin 5 (IL-5) as Measured in Nasal Exudates After a Single Dose of Low or High Dose of Oral Prednisone Relative to Placebo

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants	10 mg Prednisone n=19 Participants	25 mg Prednisone n=19 Participants
Fold Change From Baseline at Hour 8 in Interleukin 5 (IL-5) Concentration	26.94 Fold Change Interval 7.33 to 99.0	6.70 Fold Change Interval 1.82 to 24.61	1.86 Fold Change Interval 0.51 to 6.83

SECONDARY outcome

Timeframe: Baseline and Hour 8 post nasal allergen challenge

Population: All Patients with Slide Quality ≤ 3 (Slide Quality measured on a 6 point scale with values \> 3 indicating a level of debris that interferes with cell typing and counting).

Comparison of the Change in the Percent of Total Cells That Are Eosinophils Measured in Nasal Lavage After a Single Dose of 10 mg or 25 mg Prednisone Relative to Placebo

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants	10 mg Prednisone n=8 Participants	25 mg Prednisone n=9 Participants
Change From Baseline at Hour 8 in the Percent of Total Cells That Are Eosinophils	2.28 Percentage of cells that are eosinophils Interval -12.33 to 16.79	3.17 Percentage of cells that are eosinophils Interval -9.19 to 15.52	6.02 Percentage of cells that are eosinophils Interval -4.17 to 16.21

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

10 mg Prednisone

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

25 mg Prednisone

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

Results disclosure agreements

Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Other adverse events
Measure	Placebo n=19 participants at risk	10 mg Prednisone n=19 participants at risk	25 mg Prednisone n=19 participants at risk
Gastrointestinal disorders Diarrhoea	0.00% 0/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	0.00% 0/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	5.3% 1/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.
Gastrointestinal disorders Toothache	5.3% 1/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	0.00% 0/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	0.00% 0/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.
Infections and infestations Nasopharyngitis	0.00% 0/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	0.00% 0/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	5.3% 1/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.
Infections and infestations Oral Herpes	5.3% 1/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	10.5% 2/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	0.00% 0/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.
Infections and infestations Tonsillitis	0.00% 0/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	0.00% 0/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	5.3% 1/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.
Infections and infestations Vulvovaginal Candidiasis	5.3% 1/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	0.00% 0/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	0.00% 0/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.
Investigations Culture Urine Positive	5.3% 1/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	0.00% 0/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	0.00% 0/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	0.00% 0/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	5.3% 1/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.
Nervous system disorders Dizziness	5.3% 1/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	5.3% 1/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	5.3% 1/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.
Nervous system disorders Headache	10.5% 2/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	0.00% 0/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	10.5% 2/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	5.3% 1/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	5.3% 1/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.
Respiratory, thoracic and mediastinal disorders Dry Throat	0.00% 0/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	5.3% 1/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	0.00% 0/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.
Respiratory, thoracic and mediastinal disorders Epistaxis	31.6% 6/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	10.5% 2/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	5.3% 1/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.
Respiratory, thoracic and mediastinal disorders Nasal Discomfort	0.00% 0/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	5.3% 1/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	0.00% 0/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.
Respiratory, thoracic and mediastinal disorders Nasal Mucosal Disorder	0.00% 0/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	0.00% 0/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	5.3% 1/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	5.3% 1/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	10.5% 2/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	0.00% 0/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.
Respiratory, thoracic and mediastinal disorders Rhinitis Seasonal	0.00% 0/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	5.3% 1/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	0.00% 0/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	5.3% 1/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	5.3% 1/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	0.00% 0/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.
Respiratory, thoracic and mediastinal disorders Sneezing	5.3% 1/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	5.3% 1/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	5.3% 1/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.
Respiratory, thoracic and mediastinal disorders Throat Irritation	0.00% 0/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	5.3% 1/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	5.3% 1/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.
Respiratory, thoracic and mediastinal disorders Upper Airway Obstruction	5.3% 1/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	5.3% 1/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	0.00% 0/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.
Skin and subcutaneous tissue disorders Skin Irritation	0.00% 0/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	5.3% 1/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.	0.00% 0/19 • Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed. AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.