Clinical trial NCT01401465: Study To Evaluate Patient Preference, Satisfaction And Efficacy Of a Nasal Aerosol Versus an Aqueous Nasal Spray
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Perennial Allergic Rhinitis
Keywords: perennial allergic rhinitis
PAR
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2011-07-25
Enrollment: 327
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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

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 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.

Primary outcomes:
measure: Total Preference Composite Score Assessed at the End of the Study. The Total Preference Score is the Standardized Sum of 17 Individual Preference Items
timeFrame: End of Study - Day 43
measure: Change From Baseline in Regimen Attributes Composite Score
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
Secondary outcomes:
measure: Treatment Process Composite Preference Score
timeFrame: End of Study - Day 43
measure: Change From Baseline in Subject-reported AM and PM rTNSS Averaged Over Each 2-week Treatment Period.
timeFrame: Averages over each two week treatment period
measure: Change From Baseline in the Treatment Functional Impact Composite Score
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
measure: Change From Baseline in the Regimen Acceptance Composite Score
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
measure: Change From Baseline in the Treatment Satisfaction Rating Scale: Interference
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
measure: Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Adaptation
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
measure: Change From Baseline in the Treatment Satisfaction Rating Scale: Role Limitation
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
measure: Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Difficulties
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
measure: Change From Baseline in the Treatment Satisfaction Rating Scale: Sensory Impact
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
measure: Change From Baseline in the Treatment Satisfaction Rating Scale: Hassle
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
measure: Change From Baseline in the Treatment Satisfaction Rating Scale: Burden
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
measure: Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Management
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
measure: The Change From Baseline in the Treatment Satisfaction Rating Scale: Perceived Relief
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
measure: The Change From Baseline in Overall Quality of Life Composite Score
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
measure: The Change From Baseline in Health-Related Quality of Life: Perceived Health (Global Analogue Scale)
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
measure: The Change From Baseline in Health-Related Quality of Life: Allergic-Rhinitis Specific Symptom Interference Scale
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
measure: The Change From Baseline in Health-Related Quality of Life: General Symptom Interference Scale
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
measure: The Change From Baseline in Health-Related Quality of Life: Symptoms and Side-Effects Distress Scale
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
measure: The Change From Baseline in Health-Related Quality of Life: Mental and Emotional Health Scale
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
measure: The Change From Baseline in Health-Related Quality of Life: General Health Perceptions Scale
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
measure: The Change From Baseline in Health-Related Quality of Life: Work Well Being Questionnaire Scale
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
measure: Treatment Outcome Composite Score Assessed at the End of the Study
timeFrame: End of Study - Day 43
measure: Work/Disability Days: Bed Days
timeFrame: Period 1 (days 0-14), Period 2 (days 29-43)
measure: Work/Disability Days: Missed Work
timeFrame: Period 1 (days 0-14), Period 2 (days 29-43)
measure: Work/Disability Days: Reduced Activity Days
timeFrame: Period 1 (days 0-14), Period 2 (days 29-43)
measure: The Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
timeFrame: Over both two-week treatment periods combined
measure: The Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
timeFrame: Over both two-week treatment periods combined
measure: The Number of Subjects Experiencing AEs
timeFrame: Over both two-week treatment periods combined
measure: The Percentage of Subjects Experiencing AEs
timeFrame: Over both two-week treatment periods combined
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: Asthma and Allergy Specialists Medical Group
state: California
city: Mission Veijo
country: United States
facility: Southern California Research
state: California
city: San Diego
country: United States
facility: Allergy Associates Medical Group, Inc.
state: California
city: San Diego
country: United States
facility: Allergy & Asthma Medical Group & Research Center, A.P.C.
state: California
city: Colorado Springs
country: United States
facility: Asthma & Allergy Associates, P.C.
state: Colorado
city: North Dartmouth
country: United States
facility: Northeast Medical Research Associates, Inc.
state: Massachusetts
city: Minneappolis
country: United States
facility: Clinical Research Institute Inc.
state: Minnesota
city: St. Louis
country: United States
facility: The Clinical Research Center, L.L.C.
state: Missouri
city: Bellevue
country: United States
facility: The Asthma and Allergy Center, PC
state: Nebraska
city: Skillman
country: United States
facility: Princeton Center for Clinical Research
state: New Jersey
city: Medford
country: United States
facility: Clinical Research Institute of Southern Oregon, PC
state: Oregon
city: Portland
country: United States
facility: Allergy Associates Research Center
state: Oregon
city: Dallas
country: United States
facility: Pharmacuetical Research & Consulting, Inc.
state: Texas
city: El Paso
country: United States
facility: Western Sky Medical Research
state: Texas
city: San Antonio
country: United States
facility: Sylvania Research
state: Texas
Study officials:
References:
citation: Berger WE, Prenner B, Turner R, Meltzer EO. A patient preference and satisfaction study of ciclesonide nasal aerosol and mometasone furoate aqueous nasal spray in patients with perennial allergic rhinitis. Allergy Asthma Proc. 2013 Nov-Dec;34(6):542-50. doi: 10.2500/aap.2013.34.3705.