Phase 3
N=327
Study To Evaluate Patient Preference, Satisfaction And Efficacy Of a Nasal Aerosol Versus an Aqueous Nasal Spray
Perennial Allergic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT01401465 ↗Enrolled (actual)
327
Serious AEs
0.3%
Results posted
Apr 2013
Primary outcome: 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 — 68.3 scores on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ciclesonide (Drug); mometasone (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Sumitomo Pharma America, Inc.
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
68.3 | <0.0001 sig |
| PRIMARY Change From Baseline in Regimen Attributes Composite Score |
13.90; 4.88 | <0.0001 sig |
| SECONDARY Treatment Process Composite Preference Score |
74.087 | <0.0001 sig |
| SECONDARY Change From Baseline in Subject-reported AM and PM rTNSS Averaged Over Each 2-week Treatment Period. |
-2.4; -2.3 | — |
| SECONDARY Change From Baseline in the Treatment Functional Impact Composite Score |
12.36; 9.70 | — |
| SECONDARY Change From Baseline in the Regimen Acceptance Composite Score |
7.34; 2.99 | — |
| SECONDARY Change From Baseline in the Treatment Satisfaction Rating Scale: Interference |
17.31; 14.36 | — |
| SECONDARY Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Adaptation |
6.65; 2.19 | — |
| SECONDARY Change From Baseline in the Treatment Satisfaction Rating Scale: Role Limitation |
9.35; 6.62 | — |
| SECONDARY Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Difficulties |
-7.58; -0.13 | — |
| SECONDARY Change From Baseline in the Treatment Satisfaction Rating Scale: Sensory Impact |
21.37; 4.41 | — |
| SECONDARY Change From Baseline in the Treatment Satisfaction Rating Scale: Hassle |
24.7; 17.4 | — |
| SECONDARY Change From Baseline in the Treatment Satisfaction Rating Scale: Burden |
10.45; 8.23 | — |
| SECONDARY Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Management |
6.41; 5.38 | — |
| SECONDARY The Change From Baseline in the Treatment Satisfaction Rating Scale: Perceived Relief |
8.05; 3.77 | — |
| SECONDARY The Change From Baseline in Overall Quality of Life Composite Score |
6.64; 6.31 | — |
| SECONDARY The Change From Baseline in Health-Related Quality of Life: Perceived Health (Global Analogue Scale) |
0.82; 0.73 | — |
| SECONDARY The Change From Baseline in Health-Related Quality of Life: Allergic-Rhinitis Specific Symptom Interference Scale |
0.76; 0.71 | — |
| SECONDARY The Change From Baseline in Health-Related Quality of Life: General Symptom Interference Scale |
0.44; 0.38 | — |
| SECONDARY The Change From Baseline in Health-Related Quality of Life: Symptoms and Side-Effects Distress Scale |
34.05; 26.69 | — |
| SECONDARY The Change From Baseline in Health-Related Quality of Life: Mental and Emotional Health Scale |
6.32; 6.42 | — |
| SECONDARY The Change From Baseline in Health-Related Quality of Life: General Health Perceptions Scale |
25.00; 20.94 | — |
| SECONDARY The Change From Baseline in Health-Related Quality of Life: Work Well Being Questionnaire Scale |
0.12; 0.010 | — |
| SECONDARY Treatment Outcome Composite Score Assessed at the End of the Study |
61.598 | — |
| SECONDARY Work/Disability Days: Bed Days |
0.018; 0.013; 0.009; 0.018 | — |
| SECONDARY Work/Disability Days: Missed Work |
0.002; 0.005; 0.004; 0.004 | — |
| SECONDARY Work/Disability Days: Reduced Activity Days |
0.039; 0.067; 0.017; 0.039 | — |
| SECONDARY The Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation |
6; 4 | — |
| SECONDARY The Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation |
1.9; 1.3 | — |
| SECONDARY The Number of Subjects Experiencing AEs |
90; 67 | — |
| SECONDARY The Percentage of Subjects Experiencing AEs |
28.9; 21.5 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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 huma
Data sourced from ClinicalTrials.gov (NCT01401465). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.