Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 781 IIa |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a single-centre, randomised, double-blind, four-period, incomplete block, crossover study, with 8 days repeat dosing of intranasal Fluticasone Propionate (25, 50, 100, 200ug) and/or placebo in the Vienna Challenge Chamber in subjects with allergic rhinitis.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Fluticasone propionate 25ug | Experimental |
| |
| Fluticason propionate 50ug | Experimental |
| |
| Fluticasone propionate 100ug | Experimental |
| |
| Flutciasone propionate 200ug | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone propionate | Drug | Corticosteriod, with anti-inflammatory effects |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weighted Mean Total Nasal Symptom Score (TNSS) at 2-5 Hours Post-dose (1-4 Hours Post-start of Challenge [PSC]) in the Vienna Challenge Chamber (VCC) | The TNSS (score of 0-12), defined as the sum of the symptom scores for nasal obstruction, rhinorrhea, nasal itch, and sneeze (each scored on 0-3 scale [0=none, 1=mild, 2=moderate, 3=severe]) was measured at pre-challenge, and then every 15 minutes from 0.25 to 4 hours PSC. In the VCC, aerosolized allergen is administered in a sealed chamber to evaluate the efficacy of antihistamines/other treatments. Weighted mean TNSS was calculated by dividing the value of the area under the response time curve between 1 and 4 hours (calculated by trapezoidal rule) by the time interval of available data. | Day 8 of each study period (Periods 1-4); up to Day 158 |
| Measure | Description | Time Frame |
|---|---|---|
| Weighted Mean Nasal Airflow at 2-5 Hours Post-dose (1-4 Hours Post-start of Challenge) | Allergic rhinitis decreases the passage of air through the nose (nasal airflow) by increasing the nasal airway resistance. Rhinomanometry is used as an objective measurement of airway resistance. Nasal airflow was measured using active anterior rhinomanometry at pre-challenge, and then every 30 minutes from 0.5 to 4 hours post start of VCC. Weighted mean nasal airflow was calculated by dividing the value of the area under the response time curve between 1 and 4 hours (calculated by trapezoidal rule) by the time interval of available data. |
Not provided
Inclusion Criteria:
A female is eligible to enter and participate in the study if she is of:
Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who is post menopausal. For the purposes of this study, post menopausal is defined as 1 year without menses (FSH/LH will be also tested to confirm menopausal status); or
Child bearing potential, has a negative pregnancy test (urine) at entry, and agrees to one of the following acceptable contraceptive methods when used consistently and correctly (i.e., in accordance with the approved product label and the instructions of a physician for the duration of the study - screening visit to follow-up contact):
Pack years = Number of cigarettes per day x Number of years smoked 20
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Vienna | A-1150 | Austria |
Participants (par.) were randomized to receive treatment in one of five sequences in four study periods: ABCD, EABC, DEAB, CDEA, BCDE (A, Placebo; B, fluticasone propionate [FP] 25 micrograms [µg]: C, FP 50 µg; D, FP 100 µg; E, FP 200 µg). One par. randomized to ABCD withdrew due to an adverse event; one par. randomized to EABC withdrew consent.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo/FP 25, 50, 100, 200 µg | Participants received placebo/fluticasone propionate (FP) in a dose of 25, 50, 100, and 200 micrograms (µg) once daily as 1 nasal spray into each nostril from 2 separate devices for 8 days each, in a crossover design. Treatment was given in one of five sequences in Periods 1, 2, 3, and 4 (with a minimum of a 14-day washout period between treatments): ABCD, EABC, DEAB, CDEA, and BCDE (A, Placebo; B, FP 25 µg: C, FP 50 µg; D, FP 100 µg; E, FP 200 µg). On Day 8 of each treatment period (1 hour post-dose), participants entered the Vienna Challenge Chamber (VCC) for a 4-hour period, and the assessments were conducted 2-5 hours post-dose. All participants attended a follow-up visit within 2 to 4 weeks after their final dose, and the overall duration for participation in the study (screening to follow-up) did not exceed 158 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo comparator |
|
| Day 8 of each study period (Periods 1-4); up to Day 158 |
| Weighted Mean Nasal Secretion at 2-5 Hours Post-dose (1-4 Hours Post-start of Challenge) | Nasal secretion was measured by weighing tissues used by participants. Wet tissue weight assessments were made pre-challenge, and then every 30 minutes from 0.5 to 4 hours post start of challenge chamber throughout the study. Weighted mean nasal secretion was calculated by dividing the value of the area under the response time curve between 1 and 4 hours (calculated by trapezoidal rule) by the time interval of available data. | Day 8 of each study period (Periods 1-4); up to Day 158 |
| Weighted Mean Eye Symptom Score at 2-5 Hours Post-dose (1-4 Hours Post-start of Challenge) | The eye symptom score (total score of 0 [none] to 9 [severe]) was calculated as the sum of the symptom scores for watery eyes, itchy eyes, and red eyes, each of which was scored on a categorical scale from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), and was measured at pre-challenge, and then every 15 minutes from 0.25 to 4 hours post-start of challenge chamber. Weighted mean eye symptom score was calculated by dividing the value of the area under the response time curve between 1 and 4 hours (calculated by trapezoidal rule) by the time interval of available data. | Day 8 of each study period (Periods 1-4); up to Day 158 |
| Weighted Mean Global Symptom Score (GSS) at 5 Hours Post-dose (1-4 Hours Post-start of Challenge) | GSS (total score=0-30) is calculated as the sum of sneeze, nasal itch, rhinorrhea, nasal obstruction, cough, itchy throat, itchy ears, watery eyes, itchy eyes, and red eyes SSs, each of which was scored on a categorical scale from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), as was measured at pre-challenge, and then every 15 mins from 0.25 to 4 hours post-start of challenge chamber. Weighted mean global symptom score was evaluated by dividing the value of the area under the response time curve between 1 and 4 hours (calculated by trapezoidal rule) by the time interval of available data. | Day 8 of each study period (Periods 1-4); up to Day 158 |
| Glucocorticoid (GC) Receptor Biomarker Levels in Nasal Epithelial Scraping Samples: CCL2 | AROS Applied Biotechnology (AB) analyzed the nasal epithelial scrapings of participants and generated TaqMan (type of chemistry developed by AB to detect polymerase chain reaction [PCR] products) messenger ribonucleic acid (mRNA) biomarker expression data for CCL2, a steroid-responsive gene. Preliminary analysis of the mRNA abundance data was performed by Discovery Statistics. mRNA abundance data were normalized to the scores of GAPDH and 18S housekeeping genes. B-actin was not used. CCL2 data are presented by period to show the treatment-by-period interaction. ng, nanograms. | Day 1 (pre-dose) and Day 8 of each study period (Periods 1-4); up to Day 158 |
| Glucocorticoid (GC) Receptor Biomarker Levels in Nasal Epithelial Scraping Samples: 18S, B-actin, DUSP_1_T1, FKBP5, GAPDH, GILZ, PLAU, PTGS2, and RGS2 | AROS Applied Biotechnology (AB) analyzed the nasal epithelial scrapings of participants and generated TaqMan (type of chemistry developed by AB to detect polymerase chain reaction [PCR] products) messenger ribonucleic acid (mRNA) biomarker expression data for 7 steroid-responsive genes (DUSP_1_TI, FKBP5, GILZ, PLAU, CCL2, PTGS2, and RGS2) and 3 housekeeping reference genes (GAPDH, 18S, and b-actin). Preliminary analysis of the mRNA abundance data was performed by Discovery Statistics. mRNA abundance data were normalized to the scores of GAPDH and 18S housekeeping genes. B-actin was not used. | Day 1 (pre-dose) and Day 8 of each study period (Periods 1-4); up to Day 158 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo/FP 25, 50, 100, 200 µg | Participants received placebo/fluticasone propionate (FP) in a dose of 25, 50, 100, and 200 micrograms (µg) once daily as 1 nasal spray into each nostril from 2 separate devices for 8 days each, in a crossover design. Treatment was given in one of five sequences in Periods 1, 2, 3, and 4 (with a minimum of a 14-day washout period between treatments): ABCD, EABC, DEAB, CDEA, and BCDE (A, Placebo; B, FP 25 µg: C, FP 50 µg; D, FP 100 µg; E, FP 200 µg). On Day 8 of each treatment period (1 hour post-dose), participants entered the Vienna Challenge Chamber (VCC) for a 4-hour period, and the assessments were conducted 2-5 hours post-dose. All participants attended a follow-up visit within 2 to 4 weeks after their final dose, and the overall duration for participation in the study (screening to follow-up) did not exceed 158 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | Years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Weighted Mean Total Nasal Symptom Score (TNSS) at 2-5 Hours Post-dose (1-4 Hours Post-start of Challenge [PSC]) in the Vienna Challenge Chamber (VCC) | The TNSS (score of 0-12), defined as the sum of the symptom scores for nasal obstruction, rhinorrhea, nasal itch, and sneeze (each scored on 0-3 scale [0=none, 1=mild, 2=moderate, 3=severe]) was measured at pre-challenge, and then every 15 minutes from 0.25 to 4 hours PSC. In the VCC, aerosolized allergen is administered in a sealed chamber to evaluate the efficacy of antihistamines/other treatments. Weighted mean TNSS was calculated by dividing the value of the area under the response time curve between 1 and 4 hours (calculated by trapezoidal rule) by the time interval of available data. | All Subjects Population: all participants randomized to receive at least one dose of study treatment. Only those participants contributing data at the indicated time points were analyzed. | Posted | Mean | Standard Deviation | scores on a scale | Day 8 of each study period (Periods 1-4); up to Day 158 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Weighted Mean Nasal Airflow at 2-5 Hours Post-dose (1-4 Hours Post-start of Challenge) | Allergic rhinitis decreases the passage of air through the nose (nasal airflow) by increasing the nasal airway resistance. Rhinomanometry is used as an objective measurement of airway resistance. Nasal airflow was measured using active anterior rhinomanometry at pre-challenge, and then every 30 minutes from 0.5 to 4 hours post start of VCC. Weighted mean nasal airflow was calculated by dividing the value of the area under the response time curve between 1 and 4 hours (calculated by trapezoidal rule) by the time interval of available data. | All Subjects Population. Only those participants contributing data at the indicated time points were analyzed. | Posted | Mean | Standard Deviation | Milliliters per second (mL/s) | Day 8 of each study period (Periods 1-4); up to Day 158 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Weighted Mean Nasal Secretion at 2-5 Hours Post-dose (1-4 Hours Post-start of Challenge) | Nasal secretion was measured by weighing tissues used by participants. Wet tissue weight assessments were made pre-challenge, and then every 30 minutes from 0.5 to 4 hours post start of challenge chamber throughout the study. Weighted mean nasal secretion was calculated by dividing the value of the area under the response time curve between 1 and 4 hours (calculated by trapezoidal rule) by the time interval of available data. | All Subjects Population. Only those participants contributing data at the indicated time points were analyzed. | Posted | Mean | Standard Deviation | grams (g) | Day 8 of each study period (Periods 1-4); up to Day 158 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Weighted Mean Eye Symptom Score at 2-5 Hours Post-dose (1-4 Hours Post-start of Challenge) | The eye symptom score (total score of 0 [none] to 9 [severe]) was calculated as the sum of the symptom scores for watery eyes, itchy eyes, and red eyes, each of which was scored on a categorical scale from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), and was measured at pre-challenge, and then every 15 minutes from 0.25 to 4 hours post-start of challenge chamber. Weighted mean eye symptom score was calculated by dividing the value of the area under the response time curve between 1 and 4 hours (calculated by trapezoidal rule) by the time interval of available data. | All Subjects Population. Only those participants contributing data at the indicated time points were analyzed. | Posted | Mean | Standard Deviation | scores on a scale | Day 8 of each study period (Periods 1-4); up to Day 158 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Weighted Mean Global Symptom Score (GSS) at 5 Hours Post-dose (1-4 Hours Post-start of Challenge) | GSS (total score=0-30) is calculated as the sum of sneeze, nasal itch, rhinorrhea, nasal obstruction, cough, itchy throat, itchy ears, watery eyes, itchy eyes, and red eyes SSs, each of which was scored on a categorical scale from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), as was measured at pre-challenge, and then every 15 mins from 0.25 to 4 hours post-start of challenge chamber. Weighted mean global symptom score was evaluated by dividing the value of the area under the response time curve between 1 and 4 hours (calculated by trapezoidal rule) by the time interval of available data. | All Subjects Population. Only those participants contributing data at the indicated time points were analyzed. | Posted | Mean | Standard Deviation | scores on a scale | Day 8 of each study period (Periods 1-4); up to Day 158 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Glucocorticoid (GC) Receptor Biomarker Levels in Nasal Epithelial Scraping Samples: CCL2 | AROS Applied Biotechnology (AB) analyzed the nasal epithelial scrapings of participants and generated TaqMan (type of chemistry developed by AB to detect polymerase chain reaction [PCR] products) messenger ribonucleic acid (mRNA) biomarker expression data for CCL2, a steroid-responsive gene. Preliminary analysis of the mRNA abundance data was performed by Discovery Statistics. mRNA abundance data were normalized to the scores of GAPDH and 18S housekeeping genes. B-actin was not used. CCL2 data are presented by period to show the treatment-by-period interaction. ng, nanograms. | All Subjects Population. The data presented for each period are an average of the data collected on Day 1 and Day 8 of each period. Only those participants contributing data at the indicated time points were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | Copies of RNA detected per 50ng of total | Day 1 (pre-dose) and Day 8 of each study period (Periods 1-4); up to Day 158 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Glucocorticoid (GC) Receptor Biomarker Levels in Nasal Epithelial Scraping Samples: 18S, B-actin, DUSP_1_T1, FKBP5, GAPDH, GILZ, PLAU, PTGS2, and RGS2 | AROS Applied Biotechnology (AB) analyzed the nasal epithelial scrapings of participants and generated TaqMan (type of chemistry developed by AB to detect polymerase chain reaction [PCR] products) messenger ribonucleic acid (mRNA) biomarker expression data for 7 steroid-responsive genes (DUSP_1_TI, FKBP5, GILZ, PLAU, CCL2, PTGS2, and RGS2) and 3 housekeeping reference genes (GAPDH, 18S, and b-actin). Preliminary analysis of the mRNA abundance data was performed by Discovery Statistics. mRNA abundance data were normalized to the scores of GAPDH and 18S housekeeping genes. B-actin was not used. | All Subjects Population. The data presented are an average of the data collected on Day 1 and Day 8 of each treatment period. Only those participants contributing data at the indicated time points were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | RNA copies detected per 50 ng total RNA | Day 1 (pre-dose) and Day 8 of each study period (Periods 1-4); up to Day 158 |
|
Not provided
Serious adverse events (SAEs) and non-serious AEs were collected in the 46 participants who received placebo and FP 25, 50, and 100 µg treatments, and in the 47 participants who received FP 200 µg.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days | 0 | 46 | 4 | 46 | ||
| EG001 | 25 µg FP | Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days | 0 | 46 | 6 | 46 | ||
| EG002 | 50 µg FP | Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days | 0 | 46 | 3 | 46 | ||
| EG003 | 100 µg FP | Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days | 0 | 46 | 2 | 46 | ||
| EG004 | 200 µg FP | Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days | 0 | 47 | 1 | 47 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharygitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis bacterial | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Iron deficiency anemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Mean Difference (Final Values) |
| -1.55 |
| Standard Error of the Mean |
| 0.309 |
| 2-Sided |
| 95 |
| -2.16 |
| -0.93 |
Treatment difference (FP minus placebo) is presented as the difference in the adjusted means for treatment versus placebo. |
| No |
| Superiority or Other |
| Mean Difference (Final Values) | -1.72 | Standard Error of the Mean | 0.305 | 2-Sided | 95 | -2.33 | -1.11 | Treatment difference (FP minus placebo) is presented as the difference in the adjusted means for treatment versus placebo. | No | Superiority or Other |
| Mean Difference (Final Values) | -1.90 | Standard Error of the Mean | 0.351 | 2-Sided | 95 | -2.60 | -1.19 | Treatment difference is presented as the difference in the adjusted means for treatment versus placebo. | No | Superiority or Other |
| OG003 | 100 µg FP | Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days |
| OG004 | 200 µg FP | Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days |
|
|
| OG003 | 100 µg FP | Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days |
| OG004 | 200 µg FP | Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days |
|
|
Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
| OG003 | 100 µg FP | Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days |
| OG004 | 200 µg FP | Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days |
|
|
Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
| OG003 | 100 µg FP | Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days |
| OG004 | 200 µg FP | Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days |
|
|
| OG002 |
| 50 µg FP |
Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days |
| OG003 | 100 µg FP | Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days |
| OG004 | 200 µg FP | Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days |
|
|
| OG002 | 50 µg FP | Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days |
| OG003 | 100 µg FP | Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days |
| OG004 | 200 µg FP | Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days |
|
|