Evaluation of a Novel Questionnaire to Assess Patient Satisfaction With and Preference of Intranasal Corticosteroids for the Treatment of Allergic Rhinitis

NCT01287364 | Completed Phase 3 Results DMC

• 1 other identifier: 060-301
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 6

Brief Summary

This is an open-label, randomized, multicenter, 2-way crossover study in subjects 12 years or older with perennial allergic rhinitis (PAR) to evaluate the psychometric properties of a novel-patient administered assessment of treatment satisfaction with and preference of an Internasal Corticosteroid (INCS)

Conditions

Perennial Allergic Rhinitis

Keywords

perennial allergic rhinitis; PAR

Outcome Measures

Primary Outcomes (6)

• Treatment Satisfaction Subscales (Interference, Regimen Adaptation, Role Limitations, Sensory Impact, Regimen Difficulties, Burden, Hassle, Regimen Management, and Perceived Relief)Reliability Statistics

  Reliability for the nine treatment satisfaction subscales was established through internal consistency statistical analyses \[Cronbach's alpha (raw and standardized) coefficients were calculated\]. The correlation coefficients for these analyses ranged from 0.0 to 1.0, with higher coefficients indicating greater reliability. A coefficient of ≥ 0.7 was the standard for evidence of reliability.

  Day 1 (Pre-treatment) through Day 7 Treatment Period 2

• Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High)

  Discriminant validity tests whether the subscales differentiate among groups of respondents that differ on a pre-specified criterion, baseline rTNSS. Patients were assigned to baseline rTNSS categories of Low Symptoms(3.00 - 7.17; n = 62), Medium Symptoms (7.25 - 9.25; n = 61), or High Symptoms (9.33 - 12.00; n = 62). Reflective TNSS group served as the independent variable and the nine treatment satisfaction subscales were evaluated as dependent variables by analysis of variance models. Contrasts were tested between the Low and Medium Symptoms and the High and Low Symptom categories. Reflective TNSS group served as the independent variable and the nine treatment satisfaction subscales were evaluated as dependent variables by analysis of variance models. All of the treatment satisfaction subscales and satisfaction scales were scored from 0 (low satisfaction) to 100 (high satisfaction).

  Day 1 (Pre-treatment) through Day 7 Treatment Period 1

• Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change)

  Analysis was conducted with one-sample t-tests on the treatment satisfaction subscale change scores for Treatment Period 1 against the test criterion of "no change" (ie, change score = 0)TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. TNSS values range from 0-12 (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. All of the treatment satisfaction subscales and satisfaction scales were scored from 0 (low satisfaction) to 100 (high satisfaction).

  Day 1 (pre-treatment) through Day 7 Treatment Period 1

• Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change)

  Analysis was conducted with one-sample t-tests on the treatment satisfaction subscale change scores for Treatment Period 2 against the test criterion of "no change" (ie, change score = 0)TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. TNSS values range from 0-12 (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. All of the treatment satisfaction subscales and satisfaction scales were scored from 0 (low satisfaction) to 100 (high satisfaction).

  Day 1 (pre-treatment) through Day 7 Treatment Period 2

• Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES)

  Within-and between-responder group standardized effect sizes (SES) were calculated. The generally accepted guidelines for clinically important standard effect sizes are "small"(0.2), "medium" (0.5), and "large" (0.8). Between group SES indicates the magnitude of "treatment" differences. In this case, the groups were responders according to the baseline rTNSS scores. All of the treatment satisfaction subscales and satisfaction scales were scored from 0 (low satisfaction) to 100 (high satisfaction).

  Day 1 (Pre-treatment) through Day 29

• Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales

  Principal components analysis was conducted with varimax rotation that revealed two factors. These two factors are the principal components of the preference scale: Treatment Process and Treatment Outcomes. Loadings represent the degree each of the variables "correlates" with each of the factors. The loadings range from -1 to 1. An inspection of the factor loadings, reveals the extent to which each of the variables contributes to the meaning of each of the factors. High loading number provide meaning and interpretation of factors.

  Day 1 (Pre-treatment) through Day 29

Study Arms (2)

ciclesonide HFA followed by mometasone

EXPERIMENTAL

ciclesonide hydrofluoroalkane (HFA) nasal aerosol 80 μg once daily in first intervention period, followed by a 7-14 day washout period, after which the second intervention of mometasone nasal inhalation 200 μg once daily will be administered.

Drug: ciclesonide hydrofluoroalkane (HFA) nasal aerosol; Drug: mometasone nasal inhalation

mometasone followed by ciclesonide HFA

ACTIVE COMPARATOR

mometasone nasal inhalation 200 μg once daily in first intervention period followed by a 7-14 day washout period after which the second intervention of ciclesonide hydrofluoroalkane (HFA) nasal aerosol 80 μg once daily will be administered

Drug: ciclesonide hydrofluoroalkane (HFA) nasal aerosol; Drug: mometasone nasal inhalation

Interventions

ciclesonide hydrofluoroalkane (HFA) nasal aerosol DRUG

ciclesonide hydrofluoroalkane (HFA) nasal aerosol 80 μg once daily for one week.

ciclesonide HFA followed by mometasone; mometasone followed by ciclesonide HFA

mometasone nasal inhalation DRUG

mometasone nasal inhalation 200 μg once daily for one week

Also known as: Nasonex®

ciclesonide HFA followed by mometasone; mometasone followed by ciclesonide HFA

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Give written informed consent and assent, including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation.
• Male or female 12 years and older at 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 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 was a nasal spray.
• A demonstrated sensitivity to at least one 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 or 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 at 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: a. 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 study participation. b.Barrier method of contraception, e.g., condom and/or diaphragm with spermicide while participating in the study. c.Abstinence.
• The subject must possess a degree of understanding of written English, in the opinion of the investigator that enables them to complete the Phase V® Technologies Inc. (PVT) Modules.

You may not qualify if:

• Female subject who is pregnant or lactating.
• History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations; recent nasal biopsy; nasal trauma; or nasal ulcers or perforations. Surgery and atrophic rhinitis or rhinitis medicamentosa are not permitted within the last 60 days prior to screening.
• Presently has nasal jewelry, has had a nasal piercing, or a history of nasal surgery (e.g., rhinoplasty, septoplasty) or trauma to the nasal cavity.
• Subject is, in the investigator's judgment, having a seasonal exacerbation at screening.
• Participation in any investigational drug trial within the 30 days preceding screening 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 Nasonex.
• History of a respiratory infection or disorder (including, but not limited to, bronchitis, pneumonia, influenza, severe acute respiratory syndrome \[SARS\]) within the 14 days preceding screening.
• History of alcohol or drug abuse within 2 years preceding 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 (e.g., 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.
• Non-vaccinated exposure to or active infection with chickenpox or measles within the 21 days preceding screening.
• 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, e.g., 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

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (6)

Allergy and Asthma Associates of Southern California

Mission Viejo, California, 92691, United States

Location

Allergy & Asthma Medical Group & Research Center A.P.C.

San Diego, California, 92123, United States

Location

Northeast Medical Research Associates, Inc.

North Dartmouth, Massachusetts, 02747, United States

Location

Clinical Research Institute

Minneappolis, Minnesota, 55402, United States

Location

Princeton Center for Clinical Research

Skillman, New Jersey, 08558, United States

Location

Sylvania Research Associates

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Interventions

Nasal Sprays; Mometasone Furoate

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aerosols; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Respiratory Medical Director
• Organization: Sunovion

1-866-503-6351

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2011
• First Posted: February 1, 2011
• Study Start: February 1, 2011
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: November 2, 2012
• Results First Posted: October 31, 2012

Record last verified: 2012-10

Locations

US (6)