Full Text View
Tabular View
No Study Results Posted
Related Studies
Clinical Trial to Assess the Efficacy and Safety of Ciclesonide HFA Nasal Aerosol for the Treatment of Seasonal Allergic Rhinitis
This study has been completed.
First Received: November 11, 2008   Last Updated: August 7, 2009   History of Changes
Sponsored by: Sepracor, Inc.
Information provided by: Sepracor, Inc.
ClinicalTrials.gov Identifier: NCT00790023
  Purpose

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.


Condition Intervention Phase
Seasonal Allergic Rhinitis
Drug: 80 mcg Ciclesonide
Drug: 160 mcg Ciclesonide
Drug: Placebo
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Multicenter, Double Blind, Placebo Controlled, Parallel Group, Phase III Clinical Trial to Assess the Efficacy and Safety of Ciclesonide HFA Nasal Aerosol (160 μg Once Daily and 80 μg Once Daily) for the Treatment of Seasonal Allergic Rhinitis (SAR) to Mountain Cedar in Subjects 12 Years and Older.

Resource links provided by NLM:


Further study details as provided by Sepracor, Inc.:

Primary Outcome Measures:
  • Change from baseline in subject-reported AM and PM reflective TNSS averaged over the two-week treatment period [ Time Frame: Days -7,1,8,15 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in subject-reported AM and PM instantaneous TNSS averaged over the two-week treatment period. [ Time Frame: Days -7,1,8,15 ] [ Designated as safety issue: No ]
  • Change from baseline in subject-reported AM and PM reflective TOSS averaged over the two-week treatment period in subjects. [ Time Frame: Days -7,1,8,15 ] [ Designated as safety issue: No ]
  • Change from baseline in subject-reported AM reflective TNSS, PM reflective TNSS, AM and PM reflective TNSS at each day, averaged over each week, and averaged over the two-week treatment period. [ Time Frame: Days -7,1,8,15 ] [ Designated as safety issue: No ]
  • Change from baseline in subject-reported AM instantaneous TNSS, PM instantaneous TNSS, AM and PM instantaneous TNSS at each day, averaged over each week, and averaged over the two-week treatment period. [ Time Frame: Days -7,1,8,15 ] [ Designated as safety issue: No ]
  • Change from baseline in subject-reported AM reflective TOSS, PM reflective TOSS, AM and PM reflective TOSS at each day, averaged over each week, and averaged over the two-week treatment period in subjects. [ Time Frame: Days -7,1,8,15 ] [ Designated as safety issue: No ]
  • Change from baseline in subject-reported AM instantaneous TOSS, PM instantaneous TOSS, AM and PM instantaneous TOSS at each day, averaged over each week, and averaged over the two-week treatment period in subjects. [ Time Frame: Days -7,1,8,15 ] [ Designated as safety issue: No ]
  • Change from baseline in subject-reported individual AM reflective NSS, individual PM reflective NSS, individual AM and PM reflective NSS at each day, averaged over each week, and averaged over the two-week treatment period. [ Time Frame: Days -7,1,8,15 ] [ Designated as safety issue: No ]
  • Change from baseline in subject-reported individual AM reflective OSS, individual PM reflective OSS, individual AM and PM reflective OSS at each day, averaged over each week, and averaged over the two-week treatment period in subjects. [ Time Frame: Days -7,1,8,15 ] [ Designated as safety issue: No ]
  • Change from baseline in subject-reported individual AM instantaneous OSS, individual PM instantaneous OSS, individual AM and PM instantaneous OSS at each day, averaged over each week, and averaged over the two-week treatment period in subjects. [ Time Frame: Days -7,1,8,15 ] [ Designated as safety issue: No ]
  • Change from baseline in Rhinoconjunctivitis Quality of Life Questionnaire with Standardised Activities (RQLQ(S)) total and individual items at each day, averaged over each week, and averaged over the two-week treatment period in impaired patients. [ Time Frame: Days 1,15 ] [ Designated as safety issue: No ]
  • Time to Onset of nasal improvement, defined as the first assessment at which instantaneous TNSS for active treatment demonstrates an improvement over placebo from baseline with one-sided p-value of ≤0.025. [ Time Frame: Days 1-15 ] [ Designated as safety issue: No ]
  • Time to Onset of ocular improvement, defined: first assessment where instantaneous TOSS for active treatment demonstrates an improvement over placebo from baseline in subjects with baseline TOSS ≥5.0 [ Time Frame: Day 1-15 ] [ Designated as safety issue: No ]
  • Time to maximal effect is defined as the number of days until the first treatment day on which the estimated difference between Ciclesonide HFA and placebo is at least 90% of the largest estimated difference. [ Time Frame: Day 1-15 ] [ Designated as safety issue: No ]

Enrollment: 660
Study Start Date: November 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
80 mcg Ciclesonide: Experimental
80 ug Ciclesonide once daily
Drug: 80 mcg Ciclesonide
80 mcg Ciclesonide HFA Inhaler once daily (one actuation per nostril)
160 mcg Ciclesonide: Experimental
160 mcg Ciclesonide once daily
Drug: 160 mcg Ciclesonide
160 mcg Ciclesonide HFA Inhaler once daily (one actuation per nostril)
Placebo: Placebo Comparator
Placebo
Drug: Placebo
Placebo HFA Inhaler once daily (one actuation per nostril)

Detailed Description:

This is a randomized, double blind, placebo controlled, parallel group, multicenter study 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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

    1. 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.
    2. Barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study.
    3. 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).

Exclusion Criteria:

  • 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.
  • Initiation of immunotherapy during the study period or dose escalation during the study period. However, initiation of immunotherapy 90 days or more prior to the Screening Visit and use of a stable (maintenance) dose (30 days or more) may be considered for inclusion.
  • 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.
  • 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. However, initiation of these creams/ointments 30 days or more prior to the Visit 1 and use of a stable (maintenance) dose during the study period may be considered for inclusion.
  • Study participation by clinical investigator site employees and/or their immediate relatives.
  • Study participation by more than one subject from the same household at the same time.
  • 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 e.g. 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.
  • Any condition that, in the judgement of the investigator, would preclude the subject from completing the protocol with capture of the assessments as written.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00790023

Locations
United States, Texas
San Antonio, Texas, United States, 78229
New Braunfels, Texas, United States, 78130
Kerrville, Texas, United States, 78028
Austin, Texas, United States, 78731
Sponsors and Collaborators
Sepracor, Inc.
  More Information

No publications provided

Responsible Party: Sepracor Inc. ( Ciclesonide Medical Director )
Study ID Numbers: 060-622
Study First Received: November 11, 2008
Last Updated: August 7, 2009
ClinicalTrials.gov Identifier: NCT00790023     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Sepracor, Inc.:
SAR

Study placed in the following topic categories:
Hypersensitivity
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Ciclesonide
Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Rhinitis
Anti-Allergic Agents
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Otorhinolaryngologic Diseases
Immune System Diseases
Ciclesonide
Rhinitis
Anti-Allergic Agents
Pharmacologic Actions
Nose Diseases
Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Rhinitis, Allergic, Seasonal
Therapeutic Uses
Hypersensitivity, Immediate
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on September 10, 2009