Trial Outcomes & Findings for Study To Evaluate Patient Preference, Satisfaction And Efficacy Of a Nasal Aerosol Versus an Aqueous Nasal Spray (NCT NCT01401465)

NCT ID: NCT01401465

Last Updated: 2013-04-30

Results Overview

For the 17 individual items, patients were forced to choose their preference between ciclesonide and mometasone (item choices: 1 = prefer ciclesonide; 0 = prefer mometasone). The items for the Total Preference Score assessed 16 treatment attributes and one overall treatment preference: Ease of use, Convenience, Flexibility in daily activities, Taste, Use in public, Smell, Less "run out" of nose, Longer relief, Less "run down" of throat, Symptom relief, If both were the same price, Better appearance, Less nasal irritation, Faster relief, Number of sprays per dose, Makes nose feel, and Overall - the one preferred. The score is based on the proportion of items (x 100) preferred for ciclesonide and a score of 50 indicates no preference and scores over 50 indicate preference for ciclesonide. This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 327 participants
• Primary outcome timeframe: End of Study - Day 43
• Results posted on: 2013-04-30

Participant Flow

Participant milestones

Measure	CIC / MOM Sequence CIC/MOM: Treatment Period 1 = ciclesonide nasal aerosol 74 mcg once daily for two weeks; followed by a 2-week washout phase between treatments; next Treatment Period 2 = mometasone nasal inhalation 200 mcg once daily for two weeks	MOM / CIC Sequence MOM/CIC: Treatment Period 1 = mometasone nasal inhalation 200 mcg once daily for two weeks; followed by a 2-week washout phase between treatments; next Treatment Period 2 = ciclesonide Nasal aerosol 74 mcg once daily for two weeks
Treatment Period 1 STARTED	165	162
Treatment Period 1 COMPLETED	150	146
Treatment Period 1 NOT COMPLETED	15	16
Washout STARTED	150	146
Washout COMPLETED	150	146
Washout NOT COMPLETED	0	0
Treatment Period 2 STARTED	150	146
Treatment Period 2 COMPLETED	150	144
Treatment Period 2 NOT COMPLETED	0	2

Reasons for withdrawal

Measure	CIC / MOM Sequence CIC/MOM: Treatment Period 1 = ciclesonide nasal aerosol 74 mcg once daily for two weeks; followed by a 2-week washout phase between treatments; next Treatment Period 2 = mometasone nasal inhalation 200 mcg once daily for two weeks	MOM / CIC Sequence MOM/CIC: Treatment Period 1 = mometasone nasal inhalation 200 mcg once daily for two weeks; followed by a 2-week washout phase between treatments; next Treatment Period 2 = ciclesonide Nasal aerosol 74 mcg once daily for two weeks
Treatment Period 1 Adverse Event	4	1
Treatment Period 1 Pregnancy	0	1
Treatment Period 1 Protocol Violation	5	0
Treatment Period 1 Withdrawal by Subject	1	4
Treatment Period 1 Non-Compliance to Study Drug	1	0
Treatment Period 1 Inability to Meet Continuation Criteria	3	9
Treatment Period 1 Scheduling Difficulties	1	1
Treatment Period 2 Lost to Follow-up	0	1
Treatment Period 2 Withdrawal by Subject	0	1

Baseline Characteristics

Study To Evaluate Patient Preference, Satisfaction And Efficacy Of a Nasal Aerosol Versus an Aqueous Nasal Spray

Baseline characteristics by cohort

Measure	Sequence CIC / MOM n=165 Participants Sequence CIC/MOM: Treatment Period 1 = ciclesonide nasal aerosol 74 mcg once daily for two weeks; followed by a 2-week washout phase between treatments; next Treatment Period 2 = mometasone nasal inhalation 200 mcg once daily for two weeks	Sequence MOM / CIC n=162 Participants Sequence MOM/CIC: Treatment Period 1 = mometasone nasal inhalation 200 mcg once daily for two weeks; followed by a 2-week washout phase between treatments; next Treatment Period 2 = ciclesonide Nasal aerosol 74 mcg once daily for two weeks	Total n=327 Participants Total of all reporting groups
Age, Categorical <=18 years	18 Participants n=5 Participants	24 Participants n=7 Participants	42 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	143 Participants n=5 Participants	134 Participants n=7 Participants	277 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Age Continuous	37.5 years STANDARD_DEVIATION 14.78 • n=5 Participants	35.7 years STANDARD_DEVIATION 14.72 • n=7 Participants	36.6 years STANDARD_DEVIATION 14.76 • n=5 Participants
Sex: Female, Male Female	102 Participants n=5 Participants	99 Participants n=7 Participants	201 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants	63 Participants n=7 Participants	126 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	30 Participants n=5 Participants	38 Participants n=7 Participants	68 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	135 Participants n=5 Participants	124 Participants n=7 Participants	259 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	9 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) White	134 Participants n=5 Participants	144 Participants n=7 Participants	278 Participants n=5 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	165 participants n=5 Participants	162 participants n=7 Participants	327 participants n=5 Participants

PRIMARY outcome

Timeframe: End of Study - Day 43

Population: Intent to Treat (ITT)- All randomized subjects who received at least one dose of study medication

For the 17 individual items, patients were forced to choose their preference between ciclesonide and mometasone (item choices: 1 = prefer ciclesonide; 0 = prefer mometasone). The items for the Total Preference Score assessed 16 treatment attributes and one overall treatment preference: Ease of use, Convenience, Flexibility in daily activities, Taste, Use in public, Smell, Less "run out" of nose, Longer relief, Less "run down" of throat, Symptom relief, If both were the same price, Better appearance, Less nasal irritation, Faster relief, Number of sprays per dose, Makes nose feel, and Overall - the one preferred. The score is based on the proportion of items (x 100) preferred for ciclesonide and a score of 50 indicates no preference and scores over 50 indicate preference for ciclesonide. This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide.

Outcome measures

Measure	Ciclesonide Versus Mometasone n=295 Participants This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide	Mometasone Mometasone AQ 200 mcg
Total Preference Composite Score Assessed at the End of the Study. The Total Preference Score is the Standardized Sum of 17 Individual Preference Items	68.3 scores on a scale Standard Deviation 35.2	—

PRIMARY outcome

Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42

Population: ITT Population

The Regimen Attributes Composite Score is a composite of the Sensory Impact and Regimen Management Scales of the Allergic Rhinitis Treatment Satisfaction and Preference Scales. The Regimen Management Scale assess patient satisfaction with issues relating to dosing, ability to remember to use the spray, the ease/difficulty of the spray, and convenience of the treatment. The Sensory Impact Scale assess patient satisfaction with issues relating to sensory attributes, including medication running out of the nose, medication running down the throat, impact on smell/taste, etc. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).

Outcome measures

Measure	Ciclesonide Versus Mometasone n=312 Participants This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide	Mometasone n=311 Participants Mometasone AQ 200 mcg
Change From Baseline in Regimen Attributes Composite Score	13.90 scores on a scale Standard Error 1.36	4.88 scores on a scale Standard Error 1.36

SECONDARY outcome

Timeframe: End of Study - Day 43

Population: ITT

The Treatment Process Composite Preference Score is a standardized sum of 9 individual preference items (Ease of use, Convenience, Flexibility Daily Activity, Taste, Use in public, Smell. Less "Run out" of nose, Less "Run down" of throat, Number Sprays Dose). For each of these 9 individual items, patients were forced to choose their preference between ciclesonide nasal aerosol 74 mcg and mometasone AQ 200 mcg. Larger values greater than 50 indicated greater preference for ciclesonide, while smaller values less than 50 indicated greater preference for mometasone.

Outcome measures

Measure	Ciclesonide Versus Mometasone n=295 Participants This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide	Mometasone Mometasone AQ 200 mcg
Treatment Process Composite Preference Score	74.087 scores on a scale Standard Deviation 33.743	—

SECONDARY outcome

Timeframe: Averages over each two week treatment period

Population: Per Protocol (PP) Population

The reflective Total Nasal Symptom Score (rTNSS) is the sum of 4 Nasal Symptoms: Runny Nose, Sneezing, Itchy Nose, and Nasal Congestion. These symptoms were assessed each morning and evening, and their totals averaged to obtain a daily average rTNSS. These daily averages were averaged over the 6 days prior to treatment to obtain the baseline value, and over the 14 days of each two-week period to obtain the on-treatment averages. The baseline values were then subtracted from the on-treatment averages to obtain the change from baseline scores. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent, 1 = mild ,2 = moderate ,3 = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval.

Outcome measures

Measure	Ciclesonide Versus Mometasone n=283 Participants This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide	Mometasone n=283 Participants Mometasone AQ 200 mcg
Change From Baseline in Subject-reported AM and PM rTNSS Averaged Over Each 2-week Treatment Period.	-2.4 units on a scale Standard Error 0.12	-2.3 units on a scale Standard Error 0.12

SECONDARY outcome

Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42

Population: ITT Population

A combination of the Interference Scale, the Role Limitation Scale, and the Burden Scale. The composite score and the subscales all range from 0 (lower satisfaction) to 100 (higher satisfaction). This is an unweighted average of the combined scales.

Outcome measures

Measure	Ciclesonide Versus Mometasone n=312 Participants This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide	Mometasone n=311 Participants Mometasone AQ 200 mcg
Change From Baseline in the Treatment Functional Impact Composite Score	12.36 scores on scale Standard Error 14.7	9.70 scores on scale Standard Error 1.48

SECONDARY outcome

Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42

Population: ITT Population

A combination of the Perceived Relief Scale and the Regimen Adaptation Scale. The composite score and all subscales range from 0 (lower satisfaction) to 100 (higher satisfaction). This is an unweighted average of the combined scales.

Outcome measures

Measure	Ciclesonide Versus Mometasone n=312 Participants This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide	Mometasone n=311 Participants Mometasone AQ 200 mcg
Change From Baseline in the Regimen Acceptance Composite Score	7.34 scores on a scale Standard Error 2.79	2.99 scores on a scale Standard Error 2.79

SECONDARY outcome

Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42

Population: ITT Population

This subscale evaluates the patient's assessment of the degree to which allergy symptoms or side effects of the nasal spray interfered with daily routine, meals, recreation, family life, sleep schedules, energy levels, making plans, traveling, having fun and overall quality of life. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).

Outcome measures

Measure	Ciclesonide Versus Mometasone n=312 Participants This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide	Mometasone n=311 Participants Mometasone AQ 200 mcg
Change From Baseline in the Treatment Satisfaction Rating Scale: Interference	17.31 units on a scale Standard Error 2.18	14.36 units on a scale Standard Error 2.18

SECONDARY outcome

Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42

Population: ITT Population

This subscale evaluates the patient's assessment of the convenience of the treatment, whether the treatment was one the subject would recommend to other persons with the same condition, and the level of satisfaction with the current treatment. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).

Outcome measures

Measure	Ciclesonide Versus Mometasone n=312 Participants This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide	Mometasone n=311 Participants Mometasone AQ 200 mcg
Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Adaptation	6.65 units on a scale Standard Error 2.69	2.19 units on a scale Standard Error 2.70

SECONDARY outcome

Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42

Population: ITT Population

This subscale evaluates the patient's assessment of the degree of interference with social interactions with family, friends, travel, having fun, problems in performing work or social roles and how flexible the treatment was with scheduling life activities. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).

Outcome measures

Measure	Ciclesonide Versus Mometasone n=312 Participants This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide	Mometasone n=311 Participants Mometasone AQ 200 mcg
Change From Baseline in the Treatment Satisfaction Rating Scale: Role Limitation	9.35 units on a scale Standard Error 1.38	6.62 units on a scale Standard Error 1.38

SECONDARY outcome

Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42

Population: ITT Population

This subscale evaluates the patient's degree of pain, discomfort and side effects perceived to be associated with treatment, and the extent to which pain and discomfort were bothersome. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).

Outcome measures

Measure	Ciclesonide Versus Mometasone n=312 Participants This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide	Mometasone n=311 Participants Mometasone AQ 200 mcg
Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Difficulties	-7.58 units on a scale Standard Error 2.34	-0.13 units on a scale Standard Error 2.35

SECONDARY outcome

Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42

Population: ITT Population

This subscale evaluates the patient's assessment of the sensory attributes including medication running out of the nose, medication running down the throat, and impact on smell and taste. Issues regarding skipping the medication because of the way the nose feels and wanting to try other medications to find a better one are also included. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).

Outcome measures

Measure	Ciclesonide Versus Mometasone n=312 Participants This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide	Mometasone n=311 Participants Mometasone AQ 200 mcg
Change From Baseline in the Treatment Satisfaction Rating Scale: Sensory Impact	21.37 units on a scale Standard Error 1.90	4.41 units on a scale Standard Error 1.90

SECONDARY outcome

Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42

Population: ITT Population

This subscale focuses specifically on the patient's assessment of the amount of bother and hassle of the treatment regimen, including coordinating activities, dosing, carrying supplies, rubbing nose or eyes, blowing nose repeatedly, or facial puffiness. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction). Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).

Outcome measures

Measure	Ciclesonide Versus Mometasone n=312 Participants This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide	Mometasone n=311 Participants Mometasone AQ 200 mcg
Change From Baseline in the Treatment Satisfaction Rating Scale: Hassle	24.7 units on a scale Standard Error 2.82	17.4 units on a scale Standard Error 2.82

SECONDARY outcome

Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42

Population: ITT Population

This subscale evaluates the patient's assessment of the level of degree of burden that treatment for allergic rhinitis imposes on a number of areas, including adherence to the treatment regimen, exercise, performing daily activities, social activities, and enjoying life. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).

Outcome measures

Measure	Ciclesonide Versus Mometasone n=312 Participants This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide	Mometasone n=311 Participants Mometasone AQ 200 mcg
Change From Baseline in the Treatment Satisfaction Rating Scale: Burden	10.45 units on a scale Standard Error 1.68	8.23 units on a scale Standard Error 1.68

SECONDARY outcome

Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42

Population: ITT Population

This subscale evaluates the patient's assessment of issues relating to dosing (number of times and the time required to dose), ability to remember to use the spray, the ease/difficulty of the spray and several questions further pertaining to the convenience of the treatment. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).

Outcome measures

Measure	Ciclesonide Versus Mometasone n=312 Participants This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide	Mometasone n=311 Participants Mometasone AQ 200 mcg
Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Management	6.41 units on a scale Standard Error 1.32	5.38 units on a scale Standard Error 1.32

SECONDARY outcome

Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42

Population: ITT Population

The patient's perceived level of relief along with the degree of satisfaction associated with that amount of relief was evaluated within this scale. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).

Outcome measures

Measure	Ciclesonide Versus Mometasone n=312 Participants This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide	Mometasone n=311 Participants Mometasone AQ 200 mcg
The Change From Baseline in the Treatment Satisfaction Rating Scale: Perceived Relief	8.05 units on a scale Standard Error 3.08	3.77 units on a scale Standard Error 3.08

SECONDARY outcome

Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42

Population: ITT

Mean of all items in the Mental and Emotional Health and General Health Perceptions scales. Scores range from 100 (lower satisfaction) to 500 (higher satisfaction)

Outcome measures

Measure	Ciclesonide Versus Mometasone n=311 Participants This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide	Mometasone n=311 Participants Mometasone AQ 200 mcg
The Change From Baseline in Overall Quality of Life Composite Score	6.64 scores on a scale Standard Error 4.80	6.31 scores on a scale Standard Error 4.80

SECONDARY outcome

Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42

Population: ITT Population

The mean of 5 questions: Feeling past month 1) overall or in general, 2) physically, 3) emotionally, 4) personal life and 5) about job or work. Scores range from 100 (lower satisfaction) to 500 (higher satisfaction)

Outcome measures

Measure	Ciclesonide Versus Mometasone n=311 Participants This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide	Mometasone n=311 Participants Mometasone AQ 200 mcg
The Change From Baseline in Health-Related Quality of Life: Perceived Health (Global Analogue Scale)	0.82 units on a scale Standard Error 0.16	0.73 units on a scale Standard Error 0.16

SECONDARY outcome

Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42

Population: ITT Population

The mean of 7 questions concerning interference with life activities due to the symptoms of allergic-rhinitis (nasal congestion, runny nose, itchy throat or sneezing) interfered with your ability to perform life activities. The life activities included: 1) work, 2) social events, 3) recreational activities, 4) exercise and physical activities, 5) work effectiveness, 6) enjoying life and 7) "feeling your best". Scores range from 1 (lower satisfaction) to 6 (higher satisfaction)

Outcome measures

Measure	Ciclesonide Versus Mometasone n=311 Participants This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide	Mometasone n=311 Participants Mometasone AQ 200 mcg
The Change From Baseline in Health-Related Quality of Life: Allergic-Rhinitis Specific Symptom Interference Scale	0.76 units on a scale Standard Error 0.10	0.71 units on a scale Standard Error 0.10

SECONDARY outcome

Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42

Population: ITT Population

The mean of 7 questions concerning life interference due to nonallergic rhinitis specific symptoms ("other symptoms or health problems such as fatigue, pain and depression" with the same life activities: 1) work, 2) social events, 3) recreational activities, 4) exercise and physical activities, 5) work effectiveness, 6) enjoying life and 7) "feeling your best". Scores range from 1 (lower satisfaction) to 10 (higher satisfaction)

Outcome measures

Measure	Ciclesonide Versus Mometasone n=311 Participants This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide	Mometasone n=311 Participants Mometasone AQ 200 mcg
The Change From Baseline in Health-Related Quality of Life: General Symptom Interference Scale	0.44 units on a scale Standard Error 0.10	0.38 units on a scale Standard Error 0.10

SECONDARY outcome

Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42

Population: ITT Population

The mean of 48 questions including allergic-rhinitis and allergic-rhinitis treatment specific and general symptoms measured for prevalence, frequency and distress severity. Scores range from 100 (lower satisfaction) to 600 (higher satisfaction).

Outcome measures

Measure	Ciclesonide Versus Mometasone n=311 Participants This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide	Mometasone n=311 Participants Mometasone AQ 200 mcg
The Change From Baseline in Health-Related Quality of Life: Symptoms and Side-Effects Distress Scale	34.05 units on a scale Standard Error 4.19	26.69 units on a scale Standard Error 4.19

SECONDARY outcome

Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42

Population: ITT Population

The mean of 24 questions encompassing anxiety, depression, and loss of behavioral and emotional control (Psychological Distress), life satisfaction, positive well being and emotional ties (Psychological Well Being).Scores range from 100 (lower satisfaction) to 500 (higher satisfaction)

Outcome measures

Measure	Ciclesonide Versus Mometasone n=311 Participants This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide	Mometasone n=311 Participants Mometasone AQ 200 mcg
The Change From Baseline in Health-Related Quality of Life: Mental and Emotional Health Scale	6.32 units on a scale Standard Error 4.99	6.42 units on a scale Standard Error 4.99

SECONDARY outcome

Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42

Population: ITT Population

The mean of 11 questions on sleep disturbance, vitality and general health status. Scores range from 100 (lower satisfaction) to 500 (higher satisfaction).

Outcome measures

Measure	Ciclesonide Versus Mometasone n=310 Participants This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide	Mometasone n=311 Participants Mometasone AQ 200 mcg
The Change From Baseline in Health-Related Quality of Life: General Health Perceptions Scale	25.00 units on a scale Standard Error 6.63	20.94 units on a scale Standard Error 6.65

SECONDARY outcome

Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42

Population: ITT Population

The mean of 1 question on how many days worked and 12 questions on level of satisfaction with work, ability to do work, problems completing work (physical and emotional); 1 questions on rating of leisure activities. Scores range from 1 (lower satisfaction) to 10 (higher satisfaction).

Outcome measures

Measure	Ciclesonide Versus Mometasone n=310 Participants This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide	Mometasone n=311 Participants Mometasone AQ 200 mcg
The Change From Baseline in Health-Related Quality of Life: Work Well Being Questionnaire Scale	0.12 units on a scale Standard Error 0.06	0.010 units on a scale Standard Error 0.06

SECONDARY outcome

Timeframe: End of Study - Day 43

Population: ITT Population

Reflects preference on items concerned with perceived drug effectiveness (longer relief; symptom relief; prefer if both were the same price; for feeling better about your appearance; for few problems with irritation to nose; faster relief; how it makes your nose feel). The score is based on the proportion of items (x 100) preferred for ciclesonide and a score of 50 indicates an equal number of items preferred in the two groups. Larger values than 50 indicated greater than 50 percent of the subjects indicated preference for ciclesonide, while smaller values than 50 indicated greater than 50 percent preference for mometasone. Data is presented as the mean treatment outcome composite score. This analysis presents the comparison of ciclesonide versus mometasone in relation to preference for ciclesonide.

Outcome measures

Measure	Ciclesonide Versus Mometasone n=295 Participants This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide	Mometasone Mometasone AQ 200 mcg
Treatment Outcome Composite Score Assessed at the End of the Study	61.598 Scores on a scale Standard Deviation 40.776	—

SECONDARY outcome

Timeframe: Period 1 (days 0-14), Period 2 (days 29-43)

Population: ITT Population

Assessed at the end of each two-week treatment period

Outcome measures

Measure	Ciclesonide Versus Mometasone n=315 Participants This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide	Mometasone n=319 Participants Mometasone AQ 200 mcg
Work/Disability Days: Bed Days Period 1	0.018 Incidence Rate (#events/person-days)	0.013 Incidence Rate (#events/person-days)
Work/Disability Days: Bed Days Period 2	0.009 Incidence Rate (#events/person-days)	0.018 Incidence Rate (#events/person-days)

SECONDARY outcome

Timeframe: Period 1 (days 0-14), Period 2 (days 29-43)

Population: ITT Population

Assessed at the end of each two-week treatment period

Outcome measures

Measure	Ciclesonide Versus Mometasone n=226 Participants This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide	Mometasone n=223 Participants Mometasone AQ 200 mcg
Work/Disability Days: Missed Work Period 1	0.002 Incidence Rate (#events/person-days)	0.005 Incidence Rate (#events/person-days)
Work/Disability Days: Missed Work Period 2	0.004 Incidence Rate (#events/person-days)	0.004 Incidence Rate (#events/person-days)

SECONDARY outcome

Timeframe: Period 1 (days 0-14), Period 2 (days 29-43)

Population: IIT

Assessed at the end of each two-week treatment period

Outcome measures

Measure	Ciclesonide Versus Mometasone n=315 Participants This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide	Mometasone n=319 Participants Mometasone AQ 200 mcg
Work/Disability Days: Reduced Activity Days Period 1	0.039 Incidence Rate (#events/person-days)	0.067 Incidence Rate (#events/person-days)
Work/Disability Days: Reduced Activity Days Period 2	0.017 Incidence Rate (#events/person-days)	0.039 Incidence Rate (#events/person-days)

SECONDARY outcome

Timeframe: Over both two-week treatment periods combined

Population: ITT

Outcome measures

Measure	Ciclesonide Versus Mometasone n=311 Participants This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide	Mometasone n=312 Participants Mometasone AQ 200 mcg
The Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation	6 participants	4 participants

SECONDARY outcome

Timeframe: Over both two-week treatment periods combined

Population: ITT

Outcome measures

Measure	Ciclesonide Versus Mometasone n=311 Participants This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide	Mometasone n=312 Participants Mometasone AQ 200 mcg
The Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation	1.9 percentage of participants	1.3 percentage of participants

SECONDARY outcome

Timeframe: Over both two-week treatment periods combined

Population: ITT

Outcome measures

Measure	Ciclesonide Versus Mometasone n=311 Participants This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide	Mometasone n=312 Participants Mometasone AQ 200 mcg
The Number of Subjects Experiencing AEs	90 participants	67 participants

SECONDARY outcome

Timeframe: Over both two-week treatment periods combined

Population: ITT

Outcome measures

Measure	Ciclesonide Versus Mometasone n=311 Participants This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide	Mometasone n=312 Participants Mometasone AQ 200 mcg
The Percentage of Subjects Experiencing AEs	28.9 percentage of participants	21.5 percentage of participants

Adverse Events

Ciclesonide

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Mometasone

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ciclesonide n=311 participants at risk Ciclesonide nasal aerosol 74 mcg	Mometasone n=312 participants at risk Mometasone AQ 200 mcg
General disorders Chest Pain	0.00% 0/311	0.32% 1/312 • Number of events 1
Psychiatric disorders Completed Suicide	0.00% 0/311	0.32% 1/312 • Number of events 1

Other adverse events

Measure	Ciclesonide n=311 participants at risk Ciclesonide nasal aerosol 74 mcg	Mometasone n=312 participants at risk Mometasone AQ 200 mcg
General disorders Application site pain	6.1% 19/311 • Number of events 19	0.96% 3/312 • Number of events 3
Nervous system disorders Headache	2.3% 7/311 • Number of events 8	3.8% 12/312 • Number of events 15
Respiratory, thoracic and mediastinal disorders Epistaxis	2.3% 7/311 • Number of events 11	1.3% 4/312 • Number of events 4

Additional Information

Respiratory Medical Director

Sunovion

Phone: 1-866-503-6351

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER