Study of the Effects of Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol on Hypothalamic-Pituitary-Adrenal (HPA) Axis

NCT01033825 | Completed Phase 3 Results

• 1 other identifier: 060-610
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 6

Brief Summary

To demonstrate the effects of ciclesonide applied as a nasal aerosol and ciclesonide aqueous (AQ) nasal spray on hypothalamic-pituitary-adrenal axis.

Conditions

Perennial Allergic Rhinitis

Outcome Measures

Primary Outcomes (2)

• Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) at Baseline

  AUC(0-24h) will be computed using the linear trapezoidal rule based on the actual time of serum cortisol drawing. AUC(0-24) is then approximated by the sum of the areas of trapezoids. The trapezoid for each time interval is based on the actual times of non-missing cortisol values, and is defined by the actual time interval as the base, the line connecting the two cortisol values, and the two vertical sides at the two time points. Raw data is presented for baseline values (i.e. mean/SD), while inferential statistics are presented for week 6 values (i.e. LS mean/SE).

  Baseline

• The Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) From Baseline to Week 6 of the Double Blind Treatment Period

  Change is calculated as week 6 minus baseline. AUC(0-24h) will be computed using the linear trapezoidal rule based on the actual time of serum cortisol drawing. AUC(0-24) is then approximated by the sum of the areas of trapezoids. The trapezoid for each time interval is based on the actual times of non-missing cortisol values, and is defined by the actual time interval as the base, the line connecting the two cortisol values, and the two vertical sides at the two time points. Raw data is presented for baseline values (i.e. mean/SD), while inferential statistics are presented for week 6 values (i.e. LS mean/SE).

  week 6

Secondary Outcomes (42)

• Number of Subjects Experiencing Adverse Events (AEs)

  Weeks 0-6

• Percentage of Subjects Experiencing Adverse Events (AEs)

  Weeks 0-6

• Number of Subjects Experiencing Serious Adverse Events (SAEs).

  Weeks 0-6

• Percentage of Subjects Experiencing Serious Adverse Events (SAEs).

  Weeks 0-6

• Number of Subjects Who Discontinue Due to AEs

  Weeks 0-6

Study Arms (7)

Ciclesonide HFA Nasal Aerosol 320 mcg

EXPERIMENTAL

Ciclesonide HFA Nasal Aerosol 320 mcg once daily

Drug: Ciclesonide HFA Nasal Aerosol 320 mcg

Ciclesonide HFA Nasal Aerosol 160 mcg

EXPERIMENTAL

Ciclesonide HFA Nasal Aerosol 160 mcg once daily

Drug: Ciclesonide HFA Nasal Aerosol 160 mcg

HFA Nasal Aerosol placebo

PLACEBO COMPARATOR

HFA Nasal Aerosol Placebo once daily

Drug: HFA Nasal Aerosol placebo

Ciclesonide Aqueous Nasal Spray 200 mcg

EXPERIMENTAL

Ciclesonide Aqueous Nasal Spray 200 mcg once daily

Drug: Ciclesonide Aqueous Nasal Spray 200 mcg

AQ Nasal Spray Placebo

PLACEBO COMPARATOR

AQ Nasal Spray Placebo once daily

Drug: AQ Nasal Spray Placebo

Placebo HFA plus Dexamethasone 6 mcg

ACTIVE COMPARATOR

Placebo HFA plus Dexamethasone 6 mg once daily

Drug: Placebo plus Dexamethasone HFA

Placebo AQ plus Dexamethasone 6 mg

ACTIVE COMPARATOR

Placebo AQ plus Dexamethasone 6 mg once daily

Drug: Placebo AQ plus Dexamethasone 6 mg

Interventions

Ciclesonide HFA Nasal Aerosol 320 mcg DRUG

Ciclesonide HFA Nasal Aerosol 320 μg once daily

Ciclesonide HFA Nasal Aerosol 320 mcg

Ciclesonide HFA Nasal Aerosol 160 mcg DRUG

Ciclesonide HFA Nasal Aerosol 160 μg once daily

Ciclesonide HFA Nasal Aerosol 160 mcg

HFA Nasal Aerosol placebo DRUG

HFA Nasal Aerosol placebo once daily

HFA Nasal Aerosol placebo

Ciclesonide Aqueous Nasal Spray 200 mcg DRUG

Ciclesonide Aqueous Nasal Spray 200 mcg once daily

Also known as: Omnaris

Ciclesonide Aqueous Nasal Spray 200 mcg

AQ Nasal Spray Placebo DRUG

AQ Nasal Spray Placebo once daily

AQ Nasal Spray Placebo

Placebo plus Dexamethasone HFA DRUG

Dexamethasone capsules 6 mg once daily

Also known as: Decadron

Placebo HFA plus Dexamethasone 6 mcg

Placebo AQ plus Dexamethasone 6 mg DRUG

Placebo AQ plus Dexamethasone 6 mcg capsules once daily

Placebo AQ plus Dexamethasone 6 mg

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 (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 screening 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 to at least one allergen known to induce PAR (house dust mite, 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 the Screening visit. 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 allergen test must be consistent with the medical history of PAR and must be present in the subject's environment throughout the study.
• Subject, if female, 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.
• 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 thirty days following study participation.
• Barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study.
• Abstinence.

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 120 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 randomization 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 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, eg, glaucoma or posterior subcapsular cataracts; any systemic infection hematological, hepatic, renal, endocrine (except for controlled diabetes mellitus or postmenopausal symptoms or hypothyroidism; 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)

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

Northeast Medical Research Associates

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

Central Texas Health Research

New Braunfels, Texas, 78130, United States

Location

Sylvana Research

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Interventions

ciclesonide; Calcium Dobesilate; Dexamethasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Limitations and Caveats

Dose levels investigated were higher than the US FDA approved dose (74 mcg once daily) for allergic rhinitis subjects. Publication references to 148 and 282mcg are equivalent to 160 and 320mcg.

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: December 16, 2009
• First Posted: December 17, 2009
• Study Start: January 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: July 19, 2012
• Results First Posted: July 19, 2012

Record last verified: 2012-07

Locations

US (6)