NCT01401465已完成3 期
A Randomized Two Period Two-Way Crossover Study To Evaluate Patient Preference, Satisfaction And Efficacy Of A Nasal Aerosol Versus An Aqueous Nasal Spray Used For The Treatment Of Allergic Rhinitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 327
- 试验地点
- 15
- 主要终点
- Total Preference Composite Score Assessed at the End of the Study. The Total Preference Score is the Standardized Sum of 17 Individual Preference Items
研究概览
简要总结
This is a randomized, multicenter, 2-way crossover study in subjects 12 years or older with perennial allergic rhinitis (PAR) to evaluate patient preference, satisfaction and efficacy of ciclesonide nasal aerosol versus mometasone aqueous nasal spray. A novel patient-administered assessment, developed and validated to measure patient satisfaction with and preference of intranasal corticosteroids (INCS) for the treatment of allergic rhinitis (AR), is utilized in this study.
详细描述
This is a randomized, multicenter, 2-way crossover study in subjects 12 years or older with perennial allergic rhinitis (PAR) to evaluate patient preference, satisfaction and efficacy of ciclesonide nasal aerosol versus mometasone aqueous nasal spray. A novel patient-administered assessment, developed and validated to measure patient satisfaction with and preference of intranasal corticosteroids (INCS) for the treatment of allergic rhinitis (AR), is utilized in this study.
Subjects will be randomized to 1 of 2 treatment sequences:
Sequence 1: Treatment Period 1 = ciclesonide nasal aerosol 74 mcg once daily for two weeks; Treatment Period 2 = mometasone nasal inhalation 200 mcg once daily for two weeks Sequence 2: Treatment Period 1 = mometasone nasal inhalation 200 mcg once daily for two weeks; Treatment Period 2 = ciclesonide Nasal aerosol 74 mcg once daily for two weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Give written informed consent and/or assent (as appropriate), including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation.
- •Male or female 12 years and older prior to screening
- •Subject must be in general good health (defined as the absence of any clinically relevant abnormalities as determined by the investigator) based on screening physical examination, clinical laboratory results, and medical history.
- •A documented history of PAR to a relevant perennial allergen (house dust mites, cockroach, molds, animal dander) for a minimum of two years immediately preceding screening. The PAR must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past, and require treatment with an INCS throughout the entire study period.
- •At least one treatment for PAR during the 6 months prior to expected randomization, 14 days, with a nasal spray.
- •A demonstrated sensitivity to at least 1 allergen known to induce PAR (house dust mites, animal dander, cockroach, and molds) based on a documented result with a standard skin-prick test either within 90 days prior to screening or performed at screening. A positive test is defined as a wheal diameter at least 3 mm larger than the negative control wheal for the skin-prick test. The subject's positive test for the allergen must be consistent with the medical history of PAR and the allergen must be present in the subject's environment throughout the study.
- •Based upon subject's medical history, in the investigator's judgment, the subject is unlikely to have a seasonal allergy exacerbation during the study.
- •Subject, if female ≤ 65 years of age, must have a negative serum pregnancy test prior to screening Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control: An oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 1 month prior to entering the study with continued use throughout the study and for 30 days following completion of the study; Barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study; Abstinence.
- •The subject must possess a degree of understanding of written English, in the opinion of the investigator, that enables them to complete study participation
排除标准
- •Female subject who is pregnant or lactating.
- •History of physical findings of clinically significant nasal pathology, including nasal polyps or other respiratory tract malformations; recent nasal biopsy; nasal trauma; or nasal ulcers or perforations. Clinically insignificant findings may be allowed if, in the investigator's judgment, the findings are unlikely to impact on: the safety or efficacy of an INCS: the subject's perception of treatment with an INCS.
- •Surgery and atrophic rhinitis or rhinitis medicamentosa within the last 60 days prior to screening
- •Presently has nasal jewelry, has had a nasal piercing, or a history of nasal surgery (eg, rhinoplasty, septoplasty) or trauma to the nasal cavity.
- •Subject is, in the investigator's judgment, having a seasonal exacerbation prior to screening
- •Participation in any investigational drug trial within the 30 days prior to screening, participation in a previous study involving the ARTSP instrument, or planned participation in another investigational drug trial at any time during this study.
- •A known hypersensitivity to any corticosteroid or any of the components in the formulations of ciclesonide or mometasone.
- •History of a respiratory infection or disorder (including, but not limited to, bronchitis, pneumonia, influenza, severe acute respiratory syndrome [SARS]) within the 14 days prior to screening
- •History of alcohol or drug abuse within 2 years prior to screening
- •History of a positive test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
- •Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of beta agonists and any controller drugs (eg, theophylline, leukotriene antagonists, etc.); intermittent use (less than or equal to three uses per week) of inhaled short-acting beta-agonists is acceptable. Use of short-acting beta-agonists for exercise-induced bronchospasm is allowed.
- •Expected use of any disallowed medications during the study period.
- •Expected initiation of immunotherapy during the study period or planned dose escalation during the study period. However, initiation of immunotherapy 90 days or more prior to screening and use of a stable (maintenance) dose (30 days or more) may be considered for inclusion.
- •Non-vaccinated exposure to or active infection with chickenpox or measles within the 21 days prior to screening
- •Expected initiation of pimecrolimus cream 1% or greater or tacrolimus ointment 0.03% or greater during the study period or planned dose escalation during the study period.However, initiation of these creams/ointments 30 days or more prior to screening and use of a stable (maintenance) dose during the study period may be considered for inclusion.
- •Study participation by clinical site employees and/or their immediate relatives who reside in the same household.
- •Study participation by more than one subject from the same household.
- •Have any of the following conditions that are judged by the investigator to be clinically significant and/or affect the subject's ability to participate in the clinical trial: impaired hepatic function including alcohol related liver disease or cirrhosis, history of ocular disturbances, eg, glaucoma or posterior subcapsular cataracts any systemic infection hematological, hepatic, renal, endocrine (except for controlled diabetes mellitus or postmenopausal symptoms or hypothyroidism) disease, gastrointestinal disease, malignancy (excluding basal cell carcinoma, current neuropsychological condition with or without drug therapy
- •Any condition that, in the judgment of the investigator, would preclude the subject from completing the protocol with completion of the assessments as written.
- •Any use of mometasone nasal spray within 3 months prior to screening
- •Any prior use of ciclesonide nasal aerosol.
研究组 & 干预措施
Ciclesonide Nasal Aerosol
Experimental
74 mcg ciclesonide nasal aerosol once daily
干预措施: ciclesonide (Drug)
Mometasone Nasal Spray
Active Comparator
200 mcg mometasone aqueous nasal spray once daily
干预措施: mometasone (Drug)
结局指标
主要结局
Total Preference Composite Score Assessed at the End of the Study. The Total Preference Score is the Standardized Sum of 17 Individual Preference Items
时间窗: 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.
Change From Baseline in Regimen Attributes Composite Score
时间窗: 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).
次要结局
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- Change From Baseline in Subject-reported AM and PM rTNSS Averaged Over Each 2-week Treatment Period.(Averages over each two week treatment period)
- 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)
- 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)
- The Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation(Over both two-week treatment periods combined)
- The Number of Subjects Experiencing AEs(Over both two-week treatment periods combined)
- Treatment Process Composite Preference Score(End of Study - Day 43)
- 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)
- 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)
- 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 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 Change From Baseline in Health-Related Quality of Life: Mental and Emotional Health 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)
- Treatment Outcome Composite Score Assessed at the End of the Study(End of Study - Day 43)
- 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)
- 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 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 Change From Baseline in Health-Related Quality of Life: General Health Perceptions 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 Change From Baseline in Health-Related Quality of Life: Work Well Being Questionnaire 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)
- Work/Disability Days: Missed Work(Period 1 (days 0-14), Period 2 (days 29-43))
- Work/Disability Days: Bed Days(Period 1 (days 0-14), Period 2 (days 29-43))
- 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 Percentage of Subjects Experiencing AEs(Over both two-week treatment periods combined)
- Work/Disability Days: Reduced Activity Days(Period 1 (days 0-14), Period 2 (days 29-43))
- The Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation(Over both two-week treatment periods combined)
研究者
研究点 (15)
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