Clinical Trial to Assess the Efficacy and Safety of Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol for the Treatment of Seasonal Allergic Rhinitis

NCT00790023 | Completed Phase 3 Results

• 1 other identifier: 060-622
• Study Type: interventional
• Target: 707
• Locations: 1 country
• Sites: 4

Brief Summary

To demonstrate the efficacy of ciclesonide HFA applied as a nasal aerosol (160 μg and 80 μg) once daily compared to placebo in subjects with SAR.

Conditions

Seasonal Allergic Rhinitis

Keywords

SAR

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Daily Subject-reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) 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 (27)

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

  Week 0-2

• Change From Baseline in Daily Subject-reported AM and PM rTOSS Averaged Over the Two-week Treatment Period in Participants With a Baseline rTOSS >= 5.0

  Week 0-2

• Change From Baseline in Daily Subject-reported AM rTNSS Averaged Over the Two Week Treatment Period

  Week 0-2

• Change From Baseline in Daily Subject-reported PM rTNSS Averaged Over the Two Week Treatment Period

  Week 0-2

• Change From Baseline in Daily Subject-reported AM iTNSS Averaged Over the Two Week Treatment Period

  Week 0-2

Study Arms (3)

80 mcg Ciclesonide

EXPERIMENTAL

80 mcg Ciclesonide once daily

Drug: 80 mcg Ciclesonide

160 mcg Ciclesonide

EXPERIMENTAL

160 mcg Ciclesonide once daily

Drug: 160 mcg Ciclesonide

Placebo

PLACEBO COMPARATOR

Placebo once daily

Drug: Placebo

Interventions

80 mcg Ciclesonide DRUG

80 mcg Ciclesonide HFA Inhaler once daily (one actuation per nostril)

80 mcg Ciclesonide

160 mcg Ciclesonide DRUG

160 mcg Ciclesonide HFA Inhaler once daily (one actuation per nostril)

160 mcg Ciclesonide

Placebo DRUG

Placebo HFA Inhaler once daily (one actuation per nostril)

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.
• Male or female 12 years and older, as of the Screening Visit (Visit 1).
• 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).
• A history of SAR to Mountain Cedar for a minimum of two years immediately preceding the study Screening Visit (Visit 1). 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 Visit 1 (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 (performed at Visit 1) prior to randomization at Visit 2. Women of childbearing potential (excluding females at least two years postmenopausal or surgically sterile) must sign the Women of Childbearing Potential Addendum to the informed consent form. 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 (Visit 1) 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 (Visit 1).
• History of alcohol or drug abuse (or a positive urine drug screen at Visit 1) 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 (Visit 3) and the final Treatment Visit (Visit 5).
• 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 3 uses per week) of inhaled short acting beta-agonists is acceptable.
• Use of any prohibited 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.
• Use of topical corticosteroids in concentrations in excess of 1% hydrocortisone or equivalent within 30 days prior to Visit 2; use of a topical hydrocortisone or equivalent in any concentration covering greater than 20% of the body surface; or presence of an underlying condition (as judged by the investigator) that can reasonably be expected to require treatment with such preparations during the course of the study.

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (4)

Unknown Facility

Austin, Texas, 78731, United States

Location

Unknown Facility

Kerrville, Texas, 78028, United States

Location

Unknown Facility

New Braunfels, Texas, 78130, United States

Location

Unknown Facility

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Ratner P, Jacobs R, Mohar D, Huang H, Desai SY, Hinkle J. Evaluation of the efficacy and safety of ciclesonide hydrofluoroalkane nasal aerosol, 80 or 160 mug once daily, for the treatment of seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2010 Dec;105(6):471-9. doi: 10.1016/j.anai.2010.09.024.

  PMID: 21130386 RESULT

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

ciclesonide

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2008
• First Posted: November 13, 2008
• Study Start: November 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: April 8, 2016
• Results First Posted: June 8, 2012

Record last verified: 2016-03

Locations

US (4)