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Study Using the Environmental Exposure Unit (EEU) to Assess the Onset of Action of Ciclesonide, Applied as a Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (BY9010/M1-407)

Primary Purpose

Rhinitis, Allergic, Seasonal, Hay Fever

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Ciclesonide
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinitis, Allergic, Seasonal focused on measuring Seasonal Allergic Rhinitis, Ciclesonide, Hay Fever, SAR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Written informed consent signed and dated by the subject before conducting any study related procedure.
  2. Male or female patients 18 years and older.
  3. General good health, and free of any concomitant conditions or treatment that, in the judgment of the investigator, could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the trial.
  4. A history of SAR to short ragweed pollen for a minimum of two years immediately preceding the study entry (i.e., 2003 and 2004 pollen seasons). In the investigator's judgment, the SAR during this two- year period must have been of sufficient severity and would be expected to require treatment during the ragweed season.
  5. A demonstrated sensitivity to short ragweed pollen known to induce SAR through a standard skin prick test. A positive test is defined as a wheal diameter of at least 3 mm larger than the diluent (negative) control wheal for the skin prick test. Documentation of a positive result 12 months prior to Screening Visit (B0) is acceptable.
  6. Female is of child-bearing potential and is currently using and will continue to use a medically reliable method of contraception for the entire study duration (e.g. oral, injectable, trans-cutaneous or implantable contraceptives or intrauterine devices or double-barrier protection). Females who are not sexually active must agree to use double-barrier protection should they become sexually active during the course of the study. Women of child-bearing potential, or less than 1 year postmenopausal, will require a negative urine pregnancy test at the Screening Visit (B0) as well as prior to initiation of treatment at Treatment Visit (T0).Female subjects will be considered of non-childbearing potential and will not require a urine pregnancy test if at least one of the following apply:

    • Before menarche;
    • More than one year postmenopausal;
    • Had a hysterectomy;
    • Had a bilateral ovariectomy or salpingectomy or tubal ligation;
    • Have a congenital sterility.
  7. Capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, is capable of giving informed consent, will comply with all study requirements (visits, record keeping, etc), is suitable to participate, and will provide conscientious cooperation over the duration of the study and possesses the characteristics suitable to undertake this study.
  8. Willingness to undergo a minimum of one (1) up to a maximum of five (5) priming sessions with short ragweed pollen in the EEU.

Exclusion Criteria:

  1. Pregnancy, nursing, or donation of gametes (ova or sperm) for in vitro fertilization during the study period or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization for 30 days following the study period. Females unwilling to employ appropriate contraceptive measures to ensure that pregnancy will not occur during the study will be excluded.
  2. Have clinically significant physical findings of nasal anatomical deformities causing greater than 50% obstruction based upon the clinical estimate by the investigator, including nasal polyps, septal defects or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma, or nasal surgery and atrophic rhinitis or rhinitis medicamentosa (within the last 60 days prior to Screening Visit - B0).
  3. Participation in any investigational drug trial within the 30 days preceding the Screening Visit (B0) and thereafter.
  4. Known hypersensitivity to any corticosteroid or any of the excipients in the formulation.
  5. History of severe 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 (B0) and thereafter.
  6. History of alcohol or drug abuse within the preceding two years from Screening Visit (B0).
  7. History of a positive test for HIV, hepatitis B or hepatitis C.
  8. Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of b-agonists or any controller drugs (e.g. theophylline, leukotriene antagonist); intermittent use (less than or equal to 3 uses per week) of inhaled short-acting b-agonists is acceptable.
  9. Use of any prohibited concomitant medications within the prescribed (per protocol) exclusion periods (refer to Section 6.3 of the protocol).
  10. Use of antibiotic therapy for acute conditions within 14 days prior to the Screening Visit (B0) and thereafter. Low doses of antibiotics taken for prophylaxis are permitted if the therapy was started prior to the Screening Visit (B0) AND is expected to continue through out the Baseline Period (B0 to T0 Visit) and Treatment Visit (T0).
  11. 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 (B0) AND use of a stable (maintenance) dose (28 days or more prior to the Screening Visit (B0)) may be considered for inclusion provided no immunotherapy injections are received within 48 hours prior to a ragweed pollen exposure visit.
  12. Previous participation in an intranasal ciclesonide study.
  13. Non-vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit (B0).
  14. Exposure to systemic corticosteroids for any indication, chronic or intermittent (e.g., arthritis), during the past 60 days from Screening Visit (B0), or presence of an underlying condition that can reasonably be expected to require treatment with corticosteroids during the course of the study.
  15. Use of topical corticosteroids in concentrations in excess of 1% hydrocortisone for dermatological conditions within 30 days prior to the Screening Visit (B0), or presence of an underlying condition that can reasonably be expected to require treatment with such preparations during the course of the study (B0 to T0 Visit, both visits inclusive). Hydrocortisone of less than or equal to 1% concentration covering less than or equal to 10% of the total body surface without occlusion is acceptable.
  16. History of epilepsy or seizures (excluding febrile seizures).
  17. History of coronary artery disease, uncontrolled hypertension, or other clinically significant cardiovascular disease.
  18. History of malignancy (excluding basal cell carcinoma).
  19. 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, renal, endocrine (except for controlled diabetes mellitus or postmenopausal symptoms or hypothyroidism);
    • Gastrointestinal disease;
    • A current neuropsychiatric condition with or without drug therapy.

Sites / Locations

  • Altana/Nycomed

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Ciclesonide 200µg

Placebo

Outcomes

Primary Outcome Measures

Time to onset of action, measured by a difference from placebo in the change from baseline in patient- assessed instantaneous TNSS following treatment

Secondary Outcome Measures

Changes in TNSS from baseline at each time point
Changes in individual nasal symptom score from baseline at each time point
Proportion of patients exhibiting good/excellent response at each time point defined as all components of the patient-assessed TNSS scored as mild or less in severity.
Spontaneous and elicited adverse events (AEs)
Physical exam (including nasal exam)
Vital signs

Full Information

First Posted
April 14, 2008
Last Updated
December 1, 2016
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00659503
Brief Title
Study Using the Environmental Exposure Unit (EEU) to Assess the Onset of Action of Ciclesonide, Applied as a Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (BY9010/M1-407)
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Using the Environmental Exposure Unit (EEU) to Assess the Onset of Action of Ciclesonide, Applied as a Nasal Spray (200 mg, Once Daily), in the Treatment of Seasonal Allergic Rhinitis (SAR) in Patients 18 Years and Older
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
November 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief Summary
The primary objective of this placebo-controlled EEU study is to determine the time to onset of action of ciclesonide, applied as a nasal spray (200 mg, once daily) in patients with SAR.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Seasonal, Hay Fever
Keywords
Seasonal Allergic Rhinitis, Ciclesonide, Hay Fever, SAR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
420 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Ciclesonide 200µg
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Ciclesonide
Intervention Description
200µg Ciclesonide versus Placebo
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Time to onset of action, measured by a difference from placebo in the change from baseline in patient- assessed instantaneous TNSS following treatment
Time Frame
14 hours
Secondary Outcome Measure Information:
Title
Changes in TNSS from baseline at each time point
Time Frame
14 hours
Title
Changes in individual nasal symptom score from baseline at each time point
Time Frame
14 hours
Title
Proportion of patients exhibiting good/excellent response at each time point defined as all components of the patient-assessed TNSS scored as mild or less in severity.
Time Frame
14 hours
Title
Spontaneous and elicited adverse events (AEs)
Time Frame
14 hours
Title
Physical exam (including nasal exam)
Time Frame
14 hours
Title
Vital signs
Time Frame
14 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent signed and dated by the subject before conducting any study related procedure. Male or female patients 18 years and older. General good health, and free of any concomitant conditions or treatment that, in the judgment of the investigator, could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the trial. A history of SAR to short ragweed pollen for a minimum of two years immediately preceding the study entry (i.e., 2003 and 2004 pollen seasons). In the investigator's judgment, the SAR during this two- year period must have been of sufficient severity and would be expected to require treatment during the ragweed season. A demonstrated sensitivity to short ragweed pollen known to induce SAR through a standard skin prick test. A positive test is defined as a wheal diameter of at least 3 mm larger than the diluent (negative) control wheal for the skin prick test. Documentation of a positive result 12 months prior to Screening Visit (B0) is acceptable. Female is of child-bearing potential and is currently using and will continue to use a medically reliable method of contraception for the entire study duration (e.g. oral, injectable, trans-cutaneous or implantable contraceptives or intrauterine devices or double-barrier protection). Females who are not sexually active must agree to use double-barrier protection should they become sexually active during the course of the study. Women of child-bearing potential, or less than 1 year postmenopausal, will require a negative urine pregnancy test at the Screening Visit (B0) as well as prior to initiation of treatment at Treatment Visit (T0).Female subjects will be considered of non-childbearing potential and will not require a urine pregnancy test if at least one of the following apply: Before menarche; More than one year postmenopausal; Had a hysterectomy; Had a bilateral ovariectomy or salpingectomy or tubal ligation; Have a congenital sterility. Capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, is capable of giving informed consent, will comply with all study requirements (visits, record keeping, etc), is suitable to participate, and will provide conscientious cooperation over the duration of the study and possesses the characteristics suitable to undertake this study. Willingness to undergo a minimum of one (1) up to a maximum of five (5) priming sessions with short ragweed pollen in the EEU. Exclusion Criteria: Pregnancy, nursing, or donation of gametes (ova or sperm) for in vitro fertilization during the study period or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization for 30 days following the study period. Females unwilling to employ appropriate contraceptive measures to ensure that pregnancy will not occur during the study will be excluded. Have clinically significant physical findings of nasal anatomical deformities causing greater than 50% obstruction based upon the clinical estimate by the investigator, including nasal polyps, septal defects or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma, or nasal surgery and atrophic rhinitis or rhinitis medicamentosa (within the last 60 days prior to Screening Visit - B0). Participation in any investigational drug trial within the 30 days preceding the Screening Visit (B0) and thereafter. Known hypersensitivity to any corticosteroid or any of the excipients in the formulation. History of severe 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 (B0) and thereafter. History of alcohol or drug abuse within the preceding two years from Screening Visit (B0). 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 b-agonists or any controller drugs (e.g. theophylline, leukotriene antagonist); intermittent use (less than or equal to 3 uses per week) of inhaled short-acting b-agonists is acceptable. Use of any prohibited concomitant medications within the prescribed (per protocol) exclusion periods (refer to Section 6.3 of the protocol). Use of antibiotic therapy for acute conditions within 14 days prior to the Screening Visit (B0) and thereafter. Low doses of antibiotics taken for prophylaxis are permitted if the therapy was started prior to the Screening Visit (B0) AND is expected to continue through out the Baseline Period (B0 to T0 Visit) and Treatment Visit (T0). 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 (B0) AND use of a stable (maintenance) dose (28 days or more prior to the Screening Visit (B0)) may be considered for inclusion provided no immunotherapy injections are received within 48 hours prior to a ragweed pollen exposure visit. Previous participation in an intranasal ciclesonide study. Non-vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit (B0). Exposure to systemic corticosteroids for any indication, chronic or intermittent (e.g., arthritis), during the past 60 days from Screening Visit (B0), or presence of an underlying condition that can reasonably be expected to require treatment with corticosteroids during the course of the study. Use of topical corticosteroids in concentrations in excess of 1% hydrocortisone for dermatological conditions within 30 days prior to the Screening Visit (B0), or presence of an underlying condition that can reasonably be expected to require treatment with such preparations during the course of the study (B0 to T0 Visit, both visits inclusive). Hydrocortisone of less than or equal to 1% concentration covering less than or equal to 10% of the total body surface without occlusion is acceptable. History of epilepsy or seizures (excluding febrile seizures). History of coronary artery disease, uncontrolled hypertension, or other clinically significant cardiovascular disease. History of malignancy (excluding basal cell carcinoma). 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, renal, endocrine (except for controlled diabetes mellitus or postmenopausal symptoms or hypothyroidism); Gastrointestinal disease; A current neuropsychiatric condition with or without drug therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca AstraZeneca
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Altana/Nycomed
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L2V7
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4535&filename=BY9010-M1-407-RDS-2005-11-11.pdf
Description
BY9010-M1-407-RDS-2005-11-11.pdf

Learn more about this trial

Study Using the Environmental Exposure Unit (EEU) to Assess the Onset of Action of Ciclesonide, Applied as a Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (BY9010/M1-407)

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