Trial Outcomes & Findings for Efficacy and Safety of Ciclesonide Nasal Spray in Participants With Seasonal Allergic Rhinitis (SAR) in Russia (NCT NCT02155881)
NCT ID: NCT02155881
Last Updated: 2017-02-02
Results Overview
The reflective TNSS is defined as the sum of the participant-rated reflective symptom scores for the 4 nasal symptoms of runny nose, itchy nose, sneezing, and nasal congestion over the past 12 hours. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). TNSS score ranges from 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.
COMPLETED
PHASE3
80 participants
Baseline and Week 1 up to Week 2 (entire treatment period)
2017-02-02
Participant Flow
Participants took part in the study at 6 investigative sites in Russia from 12 August 2014 to 14 November 2014.
Participants with a historical diagnosis of seasonal allergic rhinitis (SAR) were enrolled in 1 of 2 treatment groups as follows: Ciclesonide 200 microgram (mcg) and Placebo.
Participant milestones
| Measure |
Ciclesonide 200 mcg
Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
|
Placebo
Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
38
|
36
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
Ciclesonide 200 mcg
Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
|
Placebo
Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Inappropriately randomized
|
2
|
2
|
Baseline Characteristics
Efficacy and Safety of Ciclesonide Nasal Spray in Participants With Seasonal Allergic Rhinitis (SAR) in Russia
Baseline characteristics by cohort
| Measure |
Ciclesonide 200 mcg
n=40 Participants
Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
|
Placebo
n=40 Participants
Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.98 years
STANDARD_DEVIATION 13.16 • n=5 Participants
|
38.55 years
STANDARD_DEVIATION 11.94 • n=7 Participants
|
39.76 years
STANDARD_DEVIATION 12.55 • n=5 Participants
|
|
Gender
Female
|
28 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Gender
Male
|
12 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
80 participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
80 participants
n=5 Participants
|
|
Smoking Status
Current Smoker
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Smoking Status
Ex-Smoker
|
1 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Smoking Status
Had Never Smoked
|
37 participants
n=5 Participants
|
34 participants
n=7 Participants
|
71 participants
n=5 Participants
|
|
Weight
|
70.03 kilogram (kg)
STANDARD_DEVIATION 16.69 • n=5 Participants
|
72.51 kilogram (kg)
STANDARD_DEVIATION 16.81 • n=7 Participants
|
71.27 kilogram (kg)
STANDARD_DEVIATION 16.75 • n=5 Participants
|
|
Height
|
166.45 centimeter (cm)
STANDARD_DEVIATION 10.87 • n=5 Participants
|
171.45 centimeter (cm)
STANDARD_DEVIATION 7.45 • n=7 Participants
|
168.95 centimeter (cm)
STANDARD_DEVIATION 9.16 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 1 up to Week 2 (entire treatment period)Population: FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using Last Observation Carried Forward (LOCF).
The reflective TNSS is defined as the sum of the participant-rated reflective symptom scores for the 4 nasal symptoms of runny nose, itchy nose, sneezing, and nasal congestion over the past 12 hours. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). TNSS score ranges from 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.
Outcome measures
| Measure |
Ciclesonide 200 mcg
n=40 Participants
Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
|
Placebo
n=40 Participants
Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
|
|---|---|---|
|
Change From Baseline Over 2 Weeks in Participant-Reported Morning and Evening Reflective Total Nasal Symptom Scores (TNSS)
Baseline
|
7.81 scores on a scale
Standard Deviation 1.83
|
7.71 scores on a scale
Standard Deviation 1.63
|
|
Change From Baseline Over 2 Weeks in Participant-Reported Morning and Evening Reflective Total Nasal Symptom Scores (TNSS)
Change Over 2 Weeks
|
-2.85 scores on a scale
Standard Deviation 2.47
|
-2.68 scores on a scale
Standard Deviation 2.11
|
SECONDARY outcome
Timeframe: Baseline and Week 1 up to Week 2 (entire treatment period)Population: FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.
The instantaneous TNSS is defined as the sum of the participant-rated instantaneous symptom scores for the 4 nasal symptoms of runny nose, itchy nose, sneezing, and nasal congestion at the time of evaluation. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). TNSS score ranges from 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.
Outcome measures
| Measure |
Ciclesonide 200 mcg
n=40 Participants
Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
|
Placebo
n=40 Participants
Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
|
|---|---|---|
|
Change From Baseline Over 2 Weeks in Participant-Reported Morning and Evening Instantaneous Total Nasal Symptom Scores
Baseline
|
7.81 scores on a scale
Standard Deviation 1.85
|
7.64 scores on a scale
Standard Deviation 1.90
|
|
Change From Baseline Over 2 Weeks in Participant-Reported Morning and Evening Instantaneous Total Nasal Symptom Scores
Change Over 2 Weeks
|
-2.76 scores on a scale
Standard Deviation 2.34
|
-2.62 scores on a scale
Standard Deviation 2.10
|
SECONDARY outcome
Timeframe: Baseline and Week 1 up to Week 2 (entire treatment period)Population: FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.
The reflective TOSS is defined as the sum of the participant-rated reflective symptom scores for 3 ocular symptoms of itching/burning eyes, tearing/watering eyes, and redness of eyes over the past 12 hours. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). Reflective TOSS score ranges from 0-9 with 0 representing an absence of symptoms and 9 representing severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.
Outcome measures
| Measure |
Ciclesonide 200 mcg
n=40 Participants
Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
|
Placebo
n=40 Participants
Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
|
|---|---|---|
|
Change From Baseline Over 2 Weeks in Participant-Reported Morning and Evening Reflective Total Ocular Symptom Scores (TOSS)
Baseline
|
4.78 scores on a scale
Standard Deviation 1.20
|
4.75 scores on a scale
Standard Deviation 1.32
|
|
Change From Baseline Over 2 Weeks in Participant-Reported Morning and Evening Reflective Total Ocular Symptom Scores (TOSS)
Change Over 2 Weeks
|
-1.68 scores on a scale
Standard Deviation 1.66
|
-1.68 scores on a scale
Standard Deviation 1.66
|
SECONDARY outcome
Timeframe: Baseline and Week 1 up to Week 2 (entire treatment period)Population: FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.
The instantaneous TOSS is defined as the sum of the participant-rated instantaneous symptom scores for 3 ocular symptoms of itching/burning eyes, tearing/watering eyes, and redness of eyes at the time of evaluation. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). Instantaneous TOSS score ranges from 0-9 with 0 representing an absence of symptoms and 9 representing severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.
Outcome measures
| Measure |
Ciclesonide 200 mcg
n=40 Participants
Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
|
Placebo
n=40 Participants
Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
|
|---|---|---|
|
Change From Baseline Over 2 Weeks in Participant-Reported Morning and Evening Instantaneous Total Ocular Symptom Scores
Baseline
|
4.74 scores on a scale
Standard Deviation 1.25
|
4.69 scores on a scale
Standard Deviation 1.53
|
|
Change From Baseline Over 2 Weeks in Participant-Reported Morning and Evening Instantaneous Total Ocular Symptom Scores
Change Over 2 Weeks
|
-1.56 scores on a scale
Standard Deviation 1.67
|
-1.61 scores on a scale
Standard Deviation 1.73
|
SECONDARY outcome
Timeframe: Baseline and Week 1 up to Week 2 (entire treatment period)Population: FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.
The reflective TNSS is defined as the sum of the participant-rated reflective symptom scores for the 4 nasal symptoms of runny nose, itchy nose, sneezing, and nasal congestion over the past 12 hours. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). TNSS score ranges from 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.
Outcome measures
| Measure |
Ciclesonide 200 mcg
n=40 Participants
Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
|
Placebo
n=40 Participants
Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
|
|---|---|---|
|
Change From Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Nasal Symptom Score
Nasal Congestion: Baseline
|
2.19 scores on a scale
Standard Deviation 0.50
|
2.22 scores on a scale
Standard Deviation 0.38
|
|
Change From Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Nasal Symptom Score
Nasal Congestion: Change Over 2 Weeks
|
-0.70 scores on a scale
Standard Deviation 0.64
|
-0.62 scores on a scale
Standard Deviation 0.63
|
|
Change From Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Nasal Symptom Score
Runny nose: Baseline
|
2.04 scores on a scale
Standard Deviation 0.61
|
2.01 scores on a scale
Standard Deviation 0.64
|
|
Change From Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Nasal Symptom Score
Runny nose: Change Over 2 Weeks
|
-0.79 scores on a scale
Standard Deviation 0.71
|
-0.77 scores on a scale
Standard Deviation 0.64
|
|
Change From Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Nasal Symptom Score
Itchy Nose: Baseline
|
1.77 scores on a scale
Standard Deviation 0.65
|
1.76 scores on a scale
Standard Deviation 0.43
|
|
Change From Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Nasal Symptom Score
Itchy Nose: Change Over 2 Weeks
|
-0.64 scores on a scale
Standard Deviation 0.66
|
-0.64 scores on a scale
Standard Deviation 0.58
|
|
Change From Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Nasal Symptom Score
Sneezing: Baseline
|
1.80 scores on a scale
Standard Deviation 0.58
|
1.73 scores on a scale
Standard Deviation 0.56
|
|
Change From Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Nasal Symptom Score
Sneezing: Change Over 2 Weeks
|
-0.71 scores on a scale
Standard Deviation 0.76
|
-0.64 scores on a scale
Standard Deviation 0.69
|
SECONDARY outcome
Timeframe: Baseline and Week 1 up to Week 2 (entire treatment period)Population: FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.
The reflective TOSS is defined as the sum of the participant-rated reflective symptom scores for 3 ocular symptoms of itching/burning eyes, tearing/watering eyes, and redness of eyes over the past 12 hours. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). Reflective TOSS score ranges from 0-9 with 0 representing an absence of symptoms and 9 representing severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.
Outcome measures
| Measure |
Ciclesonide 200 mcg
n=40 Participants
Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
|
Placebo
n=40 Participants
Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
|
|---|---|---|
|
Change From Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Ocular Symptom Score
Itching/Burning Eyes: Baseline
|
1.85 scores on a scale
Standard Deviation 0.54
|
1.79 scores on a scale
Standard Deviation 0.53
|
|
Change From Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Ocular Symptom Score
Itching/Burning Eyes: Change Over 2 Weeks
|
-0.63 scores on a scale
Standard Deviation 0.77
|
-0.73 scores on a scale
Standard Deviation 0.68
|
|
Change From Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Ocular Symptom Score
Redness: Baseline
|
1.57 scores on a scale
Standard Deviation 0.63
|
1.67 scores on a scale
Standard Deviation 0.53
|
|
Change From Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Ocular Symptom Score
Redness: Change Over 2 Weeks
|
-0.59 scores on a scale
Standard Deviation 0.59
|
-0.52 scores on a scale
Standard Deviation 0.64
|
|
Change From Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Ocular Symptom Score
Tearing/Watering Eyes: Baseline
|
1.37 scores on a scale
Standard Deviation 0.53
|
1.29 scores on a scale
Standard Deviation 0.58
|
|
Change From Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Ocular Symptom Score
Tearing/Watering Eyes: Change Over 2 Weeks
|
-0.45 scores on a scale
Standard Deviation 0.56
|
-0.43 scores on a scale
Standard Deviation 0.61
|
SECONDARY outcome
Timeframe: Baseline and Week 1 up to Week 2 (entire treatment period)Population: FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.
The RQLQ is a 28-item, disease-specific quality of life questionnaire that measures the functional (physical, emotional, and social) problems troublesome to adults with allergies. The RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms and emotional). All 28 questions were evaluated by the participant in an assessment diary over 2 weeks of treatment period and was rated on a 7-point severity scale ranging from 0 to 6, where 0 = least severe to 6 = extremely severe. Overall total score was calculated by taking the mean of the response of all individual 28 questions. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.
Outcome measures
| Measure |
Ciclesonide 200 mcg
n=40 Participants
Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
|
Placebo
n=40 Participants
Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
|
|---|---|---|
|
Change From Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score
Baseline
|
3.31 scores on a scale
Standard Deviation 0.83
|
3.24 scores on a scale
Standard Deviation 0.85
|
|
Change From Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score
Change Over 2 Weeks
|
-1.40 scores on a scale
Standard Deviation 1.26
|
-1.09 scores on a scale
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: Baseline and Week 1 up to Week 2 (entire treatment period)Population: FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.
The RQLQ is a 28-item, disease-specific quality of life questionnaire that measures the functional (physical, emotional, and social) problems troublesome to adults with allergies. The RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms and emotional). All 28 questions were evaluated by the participant in an assessment diary over 2 weeks of treatment period and was rated on a 7-point severity scale ranging from 0 to 6, where 0 = least severe to 6 = extremely severe. Overall domain scores were calculated by taking the mean of the response of the relevant questions. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.
Outcome measures
| Measure |
Ciclesonide 200 mcg
n=40 Participants
Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
|
Placebo
n=40 Participants
Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
|
|---|---|---|
|
Change From Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Individual Domain Score
Activities: Baseline
|
4.07 scores on a scale
Standard Deviation 0.77
|
4.05 scores on a scale
Standard Deviation 1.03
|
|
Change From Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Individual Domain Score
Activities: Change Over 2 Weeks
|
-1.55 scores on a scale
Standard Deviation 1.31
|
-1.24 scores on a scale
Standard Deviation 1.23
|
|
Change From Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Individual Domain Score
Sleep: Baseline
|
3.22 scores on a scale
Standard Deviation 1.41
|
3.15 scores on a scale
Standard Deviation 1.31
|
|
Change From Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Individual Domain Score
Sleep: Change Over 2 Weeks
|
-1.38 scores on a scale
Standard Deviation 1.52
|
-1.02 scores on a scale
Standard Deviation 1.39
|
|
Change From Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Individual Domain Score
Non-Nose/Eye Symptoms: Baseline
|
2.74 scores on a scale
Standard Deviation 1.21
|
2.85 scores on a scale
Standard Deviation 1.00
|
|
Change From Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Individual Domain Score
Non-Nose/Eye Symptoms: Change Over 2 Weeks
|
-1.07 scores on a scale
Standard Deviation 1.23
|
-0.90 scores on a scale
Standard Deviation 1.04
|
|
Change From Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Individual Domain Score
Practical Problems: Baseline
|
4.01 scores on a scale
Standard Deviation 1.07
|
3.50 scores on a scale
Standard Deviation 1.25
|
|
Change From Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Individual Domain Score
Practical Problems: Change Over 2 Weeks
|
-1.76 scores on a scale
Standard Deviation 1.58
|
-1.18 scores on a scale
Standard Deviation 1.26
|
|
Change From Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Individual Domain Score
Nasal Symptoms: Baseline
|
4.05 scores on a scale
Standard Deviation 0.94
|
3.90 scores on a scale
Standard Deviation 1.19
|
|
Change From Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Individual Domain Score
Nasal Symptoms: Change Over 2 Weeks
|
-1.78 scores on a scale
Standard Deviation 1.67
|
-1.44 scores on a scale
Standard Deviation 1.45
|
|
Change From Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Individual Domain Score
Eye Symptoms: Baseline
|
3.01 scores on a scale
Standard Deviation 1.19
|
2.91 scores on a scale
Standard Deviation 1.07
|
|
Change From Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Individual Domain Score
Eye Symptoms: Change Over 2 Weeks
|
-1.28 scores on a scale
Standard Deviation 1.40
|
-1.03 scores on a scale
Standard Deviation 1.14
|
|
Change From Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Individual Domain Score
Emotional: Baseline
|
2.82 scores on a scale
Standard Deviation 1.35
|
2.89 scores on a scale
Standard Deviation 1.18
|
|
Change From Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Individual Domain Score
Emotional: Change Over 2 Weeks
|
-1.39 scores on a scale
Standard Deviation 1.45
|
-1.06 scores on a scale
Standard Deviation 1.44
|
Adverse Events
Ciclesonide 200 mcg
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ciclesonide 200 mcg
n=40 participants at risk
Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
|
Placebo
n=40 participants at risk
Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
|
|---|---|---|
|
Psychiatric disorders
Insomnia
|
0.00%
0/40 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind study drug (Day 29).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.5%
1/40 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind study drug (Day 29).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
10.0%
4/40 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind study drug (Day 29).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.0%
6/40 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind study drug (Day 29).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Migraine
|
0.00%
0/40 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind study drug (Day 29).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.5%
1/40 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind study drug (Day 29).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
2/40 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind study drug (Day 29).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/40 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind study drug (Day 29).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/40 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind study drug (Day 29).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.5%
1/40 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind study drug (Day 29).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
2.5%
1/40 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind study drug (Day 29).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.5%
1/40 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind study drug (Day 29).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.5%
1/40 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind study drug (Day 29).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
2/40 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind study drug (Day 29).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/40 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind study drug (Day 29).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.5%
1/40 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind study drug (Day 29).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Asthenia
|
2.5%
1/40 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind study drug (Day 29).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/40 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind study drug (Day 29).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Chest pain
|
2.5%
1/40 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind study drug (Day 29).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/40 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind study drug (Day 29).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Decreased activity
|
2.5%
1/40 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind study drug (Day 29).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/40 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind study drug (Day 29).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
AstraZeneca Clinical Study Information Center
AstraZeneca
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi-site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER