Trial · NCT01401465
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 31
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Preference Composite Score Assessed at the End of the Study. The Total Preference Score is the Standardized Sum of 17 Individual Preference Items | End of Study - Day 43 | 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. |
| Primary | Change From Baseline in Regimen Attributes Composite Score | 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 | 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). |
| Secondary | Treatment Process Composite Preference Score | End of Study - Day 43 | 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. |
| Secondary | Change From Baseline in Subject-reported AM and PM rTNSS Averaged Over Each 2-week Treatment Period. | Averages over each two week treatment period | 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. |
| Secondary | Change From Baseline in the Treatment Functional Impact Composite Score | 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 | 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. |
| Secondary | Change From Baseline in the Regimen Acceptance Composite Score | 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 | 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. |
| Secondary | Change From Baseline in the Treatment Satisfaction Rating Scale: Interference | 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 | 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). |
| Secondary | Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Adaptation | 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 | 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). |
| Secondary | Change From Baseline in the Treatment Satisfaction Rating Scale: Role Limitation | 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 | 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). |
| Secondary | Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Difficulties | 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 | 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). |
| Secondary | Change From Baseline in the Treatment Satisfaction Rating Scale: Sensory Impact | 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 | 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). |
| Secondary | Change From Baseline in the Treatment Satisfaction Rating Scale: Hassle | 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 | 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). |
| Secondary | Change From Baseline in the Treatment Satisfaction Rating Scale: Burden | 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 | 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). |
| Secondary | Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Management | 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 | 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). |
| Secondary | The Change From Baseline in the Treatment Satisfaction Rating Scale: Perceived Relief | 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 | 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). |
| Secondary | The Change From Baseline in Overall Quality of Life Composite Score | 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 | 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) |
| Secondary | The Change From Baseline in Health-Related Quality of Life: Perceived Health (Global Analogue Scale) | 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 | 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) |
| Secondary | The Change From Baseline in Health-Related Quality of Life: Allergic-Rhinitis Specific Symptom Interference Scale | 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 | 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) |
| Secondary | The Change From Baseline in Health-Related Quality of Life: General Symptom Interference Scale | 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 | 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) |
| Secondary | The Change From Baseline in Health-Related Quality of Life: Symptoms and Side-Effects Distress Scale | 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 | 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). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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