Study To Evaluate Patient Preference, Satisfaction And Efficacy Of a Nasal Aerosol Versus an Aqueous Nasal Spray

NCT01401465 | Completed Phase 3 Results

• 1 other identifier: 060-302
• Study Type: interventional
• Target: 327
• Locations: 1 country
• Sites: 15

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.

Conditions

Perennial Allergic Rhinitis

Keywords

perennial allergic rhinitis; PAR

Outcome Measures

Primary Outcomes (2)

• Total Preference Composite Score Assessed at the End of the Study. The Total Preference Score is the Standardized Sum of 17 Individual Preference Items

  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.

  End of Study - Day 43

• Change From Baseline in Regimen Attributes Composite Score

  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).

  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 (29)

• Treatment Process Composite Preference Score

  End of Study - Day 43

• 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 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 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

Study Arms (2)

Ciclesonide Nasal Aerosol

EXPERIMENTAL

74 mcg ciclesonide nasal aerosol once daily

Drug: ciclesonide

Mometasone Nasal Spray

ACTIVE COMPARATOR

200 mcg mometasone aqueous nasal spray once daily

Drug: mometasone

Interventions

ciclesonide DRUG

74 mcg ciclesonide nasal aerosol once daily

Ciclesonide Nasal Aerosol

mometasone DRUG

200 mcg mometasone aqueous nasal spray once daily

Mometasone Nasal Spray

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/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

You may not qualify if:

• 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.
• Non-vaccinated exposure to or active infection with chickenpox or measles within the 21 days prior to 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.

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (15)

Asthma and Allergy Specialists Medical Group

Huntington Beach, California, 92647, United States

Location

Southern California Research

Mission Veijo, California, 92691, United States

Location

Allergy Associates Medical Group, Inc.

San Diego, California, 92120, United States

Location

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

San Diego, California, 92123, United States

Location

Asthma & Allergy Associates, P.C.

Colorado Springs, Colorado, 80907, United States

Location

Northeast Medical Research Associates, Inc.

North Dartmouth, Massachusetts, 02747, United States

Location

Clinical Research Institute Inc.

Minneappolis, Minnesota, 55402, United States

Location

The Clinical Research Center, L.L.C.

St Louis, Missouri, 63141, United States

Location

The Asthma and Allergy Center, PC

Bellevue, Nebraska, 68123, United States

Location

Princeton Center for Clinical Research

Skillman, New Jersey, 08558, United States

Location

Clinical Research Institute of Southern Oregon, PC

Medford, Oregon, 97504, United States

Location

Allergy Associates Research Center

Portland, Oregon, 97202, United States

Location

Pharmacuetical Research & Consulting, Inc.

Dallas, Texas, 75231, United States

Location

Western Sky Medical Research

El Paso, Texas, 79903, United States

Location

Sylvania Research

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• 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.

  PMID: 24169063 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Interventions

ciclesonide; 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)

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
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2011
• First Posted: July 25, 2011
• Study Start: July 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: April 30, 2013
• Results First Posted: April 30, 2013

Record last verified: 2013-04

Locations

US (15)