A 6 Month Safety and Efficacy Study of Once Daily Ciclesonide Hydrofluoroalkane (HFA) in the Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older

NCT00953147 | Completed Phase 3 Results

• 1 other identifier: 060-633
• Study Type: interventional
• Target: 1,110
• Locations: 1 country
• Sites: 45

Brief Summary

This is a 6-month multi-center, randomized, double-blind, placebo-controlled, parallel group, efficacy and safety study of ciclesonide HFA nasal aerosol administered once-daily to male and female subjects 12 years or older diagnosed with perennial allergic rhinitis (PAR).

Conditions

Allergic Rhinitis; Perennial Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS (rTNSS) Averaged Over the First 6 Weeks of Double-blind Treatment

  TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, rTNSS values range from 0-12 (with 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. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

  Weeks 0-6

Secondary Outcomes (13)

• Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS (iTNSS) Averaged Over the First 6 Weeks of Double-blind Treatment

  Weeks 0-6

• Change From Baseline in Daily Subject-reported AM rTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.

  Weeks 0-6

• Change From Baseline in Daily Subject-reported PM rTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.

  Weeks 0-6

• Change From Baseline in Daily Subject-reported AM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.

  Weeks 0-6

• Change From Baseline in Daily Subject-reported PM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.

  Weeks 0-6

Study Arms (3)

Ciclesonide HFA 80 mcg once daily

EXPERIMENTAL

Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).

Drug: Ciclesonide HFA 80 mcg

Ciclesonide HFA 160 mcg once daily

EXPERIMENTAL

Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).

Drug: Ciclesonide HFA 160 mcg

Placebo once daily

PLACEBO COMPARATOR

The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.

Drug: Placebo

Interventions

Ciclesonide HFA 80 mcg DRUG

Ciclesonide HFA Nasal Aerosol 80 mcg once daily for 6 months in the treatment of Perennial Allergic Rhinitis (PAR) in subjects 12 years and older.

Ciclesonide HFA 80 mcg once daily

Ciclesonide HFA 160 mcg DRUG

Ciclesonide HFA Nasal Aerosol 160 mcg once daily for 6 months in the treatment of Perennial Allergic Rhinitis (PAR) in subjects 12 years and older.

Ciclesonide HFA 160 mcg once daily

Placebo DRUG

Placebo HFA Nasal Aerosol once daily for 6 months in the treatment of Perennial Allergic Rhinitis (PAR) in subjects 12 years and older.

Placebo once daily

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.
• Subject must be in general good health based on screening physical examination, medical history, and clinical laboratory values.
• If any of the Screening visit Hematology, Chemistries, or Urinalysis are not within the clinical laboratory's reference range, then the subject can be included only if the Investigator judges the deviations to be not clinically significant.
• A history of PAR to a relevant perennial allergen (house dust mites, cockroach, molds, animal dander) for a minimum of two years immediately preceding the study Screening visit. The PAR must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past and require treatment throughout the entire study period.
• A demonstrated sensitivity at the Screening visit to at least one allergen known to induce PAR (house dust mite, animal dander, cockroach, and molds) using a standard skin-prick test. The subject's positive allergen test must be consistent with the medical history of PAR and 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 exacerbation during the first 6 weeks of double-blind treatment.
• 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.

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 the Screening visit.
• Subject is, in the investigator's judgement, having a seasonal exacerbation at the time of screening.
• Participation in any investigational drug trial within the 30 days preceding the Screening visit or planned participation in another investigational drug trial at any time during this trial.
• A known hypersensitivity to any corticosteroid or any of the excipients in the formulation of ciclesonide.
• 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 the Screening visit.
• History of alcohol or drug abuse within 2 years preceding the Screening visit .
• History of a positive test for 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 3 uses per week) of inhaled short acting beta-agonists is acceptable. Use of short acting beta-agonists for exercise-induced bronchospasm will be allowed.
• Expected use of any disallowed concomitant medications during the treatment period.
• Previous participation in an intranasal ciclesonide HFA nasal aerosol study.
• Non-vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit.
• 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.
• Study participation by clinical investigator 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 (45)

Asthma and Allergy Specialists Medical Group

Huntington Beach, California, 92647, United States

Location

California Allergy and Asthma Medical Group

Los Angeles, California, 90025, United States

Location

Southern California Research

Mission Viejo, California, 92691, United States

Location

CHOC PSF, AMC, Division of Allergy Asthma & Immunology

Orange, California, 92868, United States

Location

California Allerga and Asthma Medical Group

Palmdale, California, 93551, United States

Location

Allergy Associates Medical Group

San Diego, California, 92120, United States

Location

Allergy and Asthma Medical Group and Research Center

San Diego, California, 92123, United States

Location

Bensch Research Associates

Stockton, California, 95207, United States

Location

Asthma and Allergy Associates, P.C.

Colorado Springs, Colorado, 80907, United States

Location

Storms Clinical Research Institute

Colorado Springs, Colorado, 80907, United States

Location

Colorado Allergy and Asthma Centers

Denver, Colorado, 80230, United States

Location

Clinical Research Atlanta

Atlanta, Georgia, 30342, United States

Location

DataQuest Medical Research, LLC

Lawrenceville, Georgia, 30046, United States

Location

Allergy and Asthma Consultants, PC

Lilburn, Georgia, 30047, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

Clinical Research Center of Indiana

Indianapolis, Indiana, 46208, United States

Location

Gordon D. Raphael, MD

Bethesda, Maryland, 20814, United States

Location

Northeast Medical Research Associates, Inc.

North Dartmouth, Massachusetts, 02747, United States

Location

The Clinical Research Center, LLC

St Louis, Missouri, 63141, United States

Location

Clinical Research Group of Montana

Bozeman, Montana, 59718, United States

Location

Princeton Center for Clinical Research

Skillman, New Jersey, 08558, United States

Location

Allergy and Asthma Center of NC

High Point, North Carolina, 27262, United States

Location

North Carolina Clinical Research

Raleigh, North Carolina, 26707, United States

Location

Toledo Center for Clinical Research

Sylvania, Ohio, 43560, United States

Location

Allergy and Asthma Research Group

Eugene, Oregon, 97401, United States

Location

Baker Allergy, Asthma and Dermatology Research Center, LLC

Lake Oswego, Oregon, 97035, United States

Location

Allergy Associates Research Center

Portland, Oregon, 97213, United States

Location

Valley Clinical Research Center

Bethlehem, Pennsylvania, 18020, United States

Location

Asthma and Allergy Research Associates

Upland, Pennsylvania, 19013, United States

Location

Asthma, Nasal Disease and Allergy Research Center of New England

Providence, Rhode Island, 02906, United States

Location

National Allergy, Asthma, and Urticaria

Charleston, South Carolina, 29406, United States

Location

Allergy and Asthma Associates

Austin, Texas, 78731, United States

Location

Sirius Clinical Research

Austin, Texas, 78759, United States

Location

Hill Country Family Medical Center

Boerne, Texas, 78006, United States

Location

Pharmaceutical Research and Consulting

Dallas, Texas, 75231, United States

Location

Western Sky Medical Research

El Paso, Texas, 79903, United States

Location

North Texas Institute for Clinical Trials

Fort Worth, Texas, 76132, United States

Location

Allergy and Asthma Associates

Houston, Texas, 77054, United States

Location

Kerrville Research Associates, PA

Kerrville, Texas, 78028, United States

Location

Kerrville Research Associates

Kerrville, Texas, 78028, United States

Location

Central Texas Health Research

New Braunfels, Texas, 78130, United States

Location

Biogenics Research Institute

San Antonio, Texas, 78229, United States

Location

Southwest Allergy and Asthma Center

San Antonio, Texas, 78229, United States

Location

Sylvana Research Associates

San Antonio, Texas, 78229, United States

Location

ASTHMA, Inc.

Seattle, Washington, 98105, United States

Location

Related Publications (1)

• Mohar D, Berger WE, Laforce C, Raphael G, Desai SY, Huang H, Hinkle J. Efficacy and tolerability study of ciclesonide nasal aerosol in patients with perennial allergic rhinitis. Allergy Asthma Proc. 2012 Jan-Feb;33(1):19-26. doi: 10.2500/aap.2012.33.3522.

  PMID: 22370530 RESULT

MeSH Terms

Conditions

Rhinitis, Allergic; Rhinitis, Allergic, Perennial

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

This study was not designed or powered for a comparison of the 80mcg dose with the 160mcg dose therefore no statistical comparisons were planned between the two active groups. Publication references to 74 and 148mcg are equivalent to 80 and 160mcg

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2009
• First Posted: August 6, 2009
• Study Start: August 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: May 1, 2010
• Last Updated: June 13, 2012
• Results First Posted: June 7, 2012

Record last verified: 2012-06

Locations

US (45)