Clinical Trial to Assess the Efficacy and Safety of Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol for the Treatment of Seasonal Allergic Rhinitis (SAR) to Mountain Cedar in Subjects 12 Years and Older

NCT01010971 | Completed Phase 3 Results

• 1 other identifier: 060-634
• Study Type: interventional
• Target: 671
• Locations: 1 country
• Sites: 7

Brief Summary

This clinical research study will evaluate the safety and effectiveness of two doses of an investigational medication (ciclesonide nasal aerosol) for the treatment of subjects with of seasonal allergic rhinitis (SAR). The study will consist of a Screening Period to confirm study eligibility, followed by a Single-Blind Placebo Run-in period to acclimate subjects to the proper use of the study medication and to assess the subject's severity of SAR symptoms, followed by a 2-week double-blind treatment period to assess the safety and effectiveness of the study medication when given to eligible subjects.

Conditions

Seasonal Allergic Rhinitis

Keywords

Mountain Cedar

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS Averaged Over the Two-week Treatment Period.

  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 two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

  Week 0-2

Secondary Outcomes (26)

• Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS Averaged Over the 2-week Treatment Period.

  Week 0-2

• Change From Baseline in Daily Subject-reported AM and PM Reflective TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0

  Week 0-2

• Change From Baseline in the RQLQ(S) Overall Score at the End of the 2-week Treatment Period in Impaired Subjects With Baseline RQLQ(S) Score of ≥3.0

  Week 0-2

• Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 2-week Treatment Period.

  Week 0-2

• Change From Baseline in Daily Subject-reported PM Reflective TNSS Averaged Over the 2 Week Treatment Period.

  Week 0-2

Study Arms (3)

Ciclesonide HFA Nasal Aerosol 160 μg

EXPERIMENTAL

160 μg once daily

Drug: Ciclesonide HFA 160 μg

Ciclesonide HFA Nasal Aerosol 80 μg

EXPERIMENTAL

80 μg once daily

Drug: Ciclesonide HFA 80 μg

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Ciclesonide HFA 160 μg DRUG

Ciclesonide HFA Nasal Aerosol 160 μg once daily

Ciclesonide HFA Nasal Aerosol 160 μg

Ciclesonide HFA 80 μg DRUG

Ciclesonide HFA Nasal Aerosol 80 μg once daily

Ciclesonide HFA Nasal Aerosol 80 μg

Placebo DRUG

Placebo HFA Nasal Aerosol once daily

Placebo

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, including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation.
• 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, medical history, and clinical laboratory values (Hematology, Chemistries and Urinalysis). If any of the 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 SAR to Mountain Cedar for a minimum of two years immediately preceding the study Screening Visit. The SAR must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past and in the Investigator's judgment (through exposure to allergen) is expected to require treatment throughout the entire study period.
• A demonstrated sensitivity to Mountain Cedar known to induce SAR through a standard skin prick test administered at screening. A positive test is defined as a wheal diameter at least 5 mm larger than the control wheal (normal saline) for the skin prick test.
• Subject, if female 65 years of age or younger, must have a negative serum pregnancy test. 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 and will continue its use throughout the study and for thirty days following study participation; Barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study; Abstinence.
• Subject or parent/guardian must possess an educational level and degree of understanding of English that enables them to communicate suitably with the Investigator and study coordinator as well as accurately complete both the AR diary and RQLQ(S).

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; nasal ulcers or perforations; or surgery and atrophic rhinitis or rhinitis medicamentosa (all within the last 60 days prior to the Screening Visit).
• 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 \[including, but not limited to bronchitis, pneumonia, chronic sinusitis, influenza, severe acute respiratory syndrome (SARS)\] within the 14 days preceding the Screening Visit .
• History of alcohol or drug abuse within two years preceding the Screening Visit.
• History of a positive test for HIV, hepatitis B or hepatitis C.
• Plans to travel outside the study area (the known pollen area for the investigative site) for more than 24 hours during the Run-in period.
• Plans to travel outside the study area (the known pollen area for the investigative site) for 2 or more consecutive days between Randomization Visit and the final Treatment Visit.
• 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 any disallowed concomitant medications within the prescribed (per protocol) time period prior to the Screening Visit and expected use during treatment period.
• Use of antibiotic therapy for acute conditions within 14 days prior to the Screening Visit. Low doses of antibiotics taken for prophylaxis are permitted if the therapy was started prior to the Screening Visit and is expected to continue throughout the trial.
• 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.
• Study participation by clinical investigator site employees and/or their immediate relatives.

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (7)

Allergy and Asthma Associates

Austin, Texas, 78731, United States

Location

Sinus Clinical Research LLC

Austin, Texas, 78759, United States

Location

Central Texas Health Research Corporation

New Braunfels, Texas, 78130, United States

Location

Biogenics Research Institute

San Antonio, Texas, 78229, United States

Location

Southwest Allergy and Asthma Research Center, Pa

San Antonio, Texas, 78229, United States

Location

Sylvana Research

San Antonio, Texas, 78229, United States

Location

Unknown Facility

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Ratner PH, Andrews C, Martin B, Howland W, Desai SY, Huang H, Hinkle J, Bode F. A study of the efficacy and safety of ciclesonide hydrofluoroalkane nasal aerosol in patients with seasonal allergic rhinitis from mountain cedar pollen. Allergy Asthma Proc. 2012 Jan-Feb;33(1):27-35. doi: 10.2500/aap.2012.33.3490.

  PMID: 22370531 RESULT

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; 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: November 6, 2009
• First Posted: November 10, 2009
• Study Start: December 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: June 13, 2012
• Results First Posted: June 8, 2012

Record last verified: 2012-06

Locations

US (7)