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Seasonal Allergic RhinitisPhase 3NCT01458275

A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Seasonal Allergic Rhinitis (SAR)

A Phase 3 study testing Ciclesonide nasal aerosol 37 mcg and ciclesonide nasal aerosol 74 mcg in people with Seasonal Allergic Rhinitis, run by Sumitomo Pharma America, Inc. at 66 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a 2-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and premenarchal female subjects 6 to 11 years-old diagnosed with SAR. Read more about this study

Who is it for?
Ages 6 to 11 years
Conditions the study is for
Seasonal Allergic Rhinitis
What is being tested?
Ciclesonide nasal aerosol 37 mcg and ciclesonide nasal aerosol 74 mcg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
847 participants
Where
66 sitesUnited States
Study dates
Nov 2011to Mar 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Gives written informed consent (parent/legal guardian) and assent (from the child), including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation.
  • Is a male or premenarchal female 6 to 11 years-old at the screening.
  • Is in general good health (defined as the absence of any clinically relevant abnormalities as determined by the investigator) based on screening physical examination and medical history.
  • Has a history of SAR to any relevant dominant seasonal allergen for a minimum of one to 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 is expected to require treatment throughout the entire study period.
  • Has a demonstrated sensitivity to a relevant dominant seasonal allergen known to induce SAR based on a documented result with a standard skin prick test either within 12 months 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 control wheal (normal saline) for the skin prick test. The subject's positive allergen test must be consistent with the medical history of SAR, and the allergen must be present in the subject's environment throughout the study.
  • 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 Allergic Rhinitis diary and Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ).

Who cannot join

  • Has a history of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations; recent unhealed nasal biopsy; nasal trauma; or nasal ulcers or perforations. Surgery and atrophic rhinitis or rhinitis medicamentosa are not permitted within the 120 days prior to the screening visit.
  • Has evidence of infection, significant anatomic abnormality, ulceration of the mucosa, blood in the nose, or any other clinically relevant finding on nasal examination at the screening visit.
  • Has nasal jewelry
  • Has participated in any investigational drug trial within the 30 days preceding the screening visit or is planning participation in another investigational drug trial at any time during this trial.
  • Has a known hypersensitivity to any corticosteroid or any of the excipients in the formulation of ciclesonide.
  • Has a history of a respiratory infection or disorder, including but not limited to bronchitis, pneumonia, influenza, and severe acute respiratory syndrome (SARS), within the 14 days preceding the screening visit.
Show all 17Show fewer
  • Has active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of beta-agonists and any controller drugs (eg, theophylline, leukotriene antagonists); intermittent use (≤ 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.
  • 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.
  • Plans to leave the study area (the known pollen area for the investigative site) for longer than 24 hours during the Single-blind Placebo Run-in period.
  • Is expecting to use any disallowed concomitant medications during the treatment period.
  • Is planning 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.
  • Has nonvaccinated exposure to or active infection with chickenpox or measles within the 21 days preceding the screening visit.
  • Initiates pimecrolimus cream 1% or greater or tacrolimus ointment 0.03% or greater during the study period or plans a dose escalation during the study period. However, initiation of these creams/ointments 30 days or more prior to screening and use of a stable (maintenance) dose during the study period may be considered for inclusion.
  • Is a child or relative of any clinical investigator or site personnel, even those who are not directly involved in this study.
  • Has any of the following conditions that are judged by the investigator to be clinically significant and/or to affect the subject's ability to participate in the clinical trial: impaired hepatic function; history of ocular disturbances, eg, glaucoma or posterior subcapsular cataracts or herpes simplex; any systemic infection hematological (including anemia), hepatic, renal, endocrine disease; gastrointestinal disease; malignancy (excluding basal cell carcinoma); current neuropsychological condition with or without drug therapy. Any behavioral condition that could affect subject's ability to accurately report symptoms to the caregiver such as developmental delay, attention deficit disorder, and autism.
  • Has any condition that, in the judgment of the investigator, would preclude the subject from completing the protocol with capture of the assessments as written.
  • Has received ciclesonide nasal aerosol in a previous clinical trial

Trial locations and contacts

66 sites in 1 country.

66 sites in 1 country

United States66 sites

  • DCT - Anchor, LLC dba Discovery Clinical Trials

    Arlington, Texas, 76018

  • Discovery Clinical Trials

    Arlington, Texas, 76018

  • Benchmark Research

    Austin, Texas, 78705

  • Isis Clinical Research, LLC

    Austin, Texas, 78731

  • Sirius Clinical Research LLC

    Austin, Texas, 78759

  • San Jose Multispecialty Medical Group, Inc

    Baldwin Park, California, 91706

  • Gordon D. Raphael, MD

    Berthesda, Maryland, 20814

  • TTS Research Center

    Boeme, Texas, 78006

  • Research Across America

    Carroliton, Texas, 75010

  • National Allergy, Asthma, and Uticaria Centers of Charleston, PA

    Charleston, South Carolina, 29407

  • Ericksen Research and Development

    Clinton, Utah, 84015

  • Asthma & Allergy Associates, PC

    Colorado Springs, Colorado, 80907

  • Storms Clinical Research Institute

    Colorado Springs, Colorado, 80907

  • WCCT Global, LLC

    Costa Mesa, California, 92626

  • Dallas Allergy Immunology Research

    Dallas, Texas, 75230

  • Pharmaceutical Research and Consulting

    Dallas, Texas, 75231

  • Colorado Allergy and Asthma Centers, PC

    Denver, Colorado, 80230

  • Premier Health Research Center

    Downey, California, 90241

  • Western Sky Medical Research

    El Paso, Texas, 79903

  • Alzein Pediatrics

    Evergreen Park, Illinois, 60805

  • Catalyst Medical Center

    Fargo, North Dakota, 58103

  • Benchmark Research

    Fort Worth, Texas, 76135

  • Allergy, Asthma, Brochitis and Immunology Assoc Medical Group

    Fountain Valley, California, 92708

  • Northeast Georgia Research Center

    Gainesville, Georgia, 30501

  • Pediatric Care Medical Group, Inc.

    Huntington Beach, California, 92647

  • Pediatric Care Medical Group

    Huntington Beach, California, 92647

  • Kerrville Research Associates

    Kerrville, Texas, 78028

  • Baker Allergy Asthma and Dermatology Research Center LLC

    Lake Oswego, Oregon, 97035

  • DataQuest Medical Research, LLC

    Lawerenceville, Georgia, 30046

  • Arkansas Pediatric Clinic

    Little Rock, Arkansas, 72205

  • Live Oak Allergy and Asthma Clinic

    Live Oak, Texas, 78233

  • Atlanta Allergy & Astma Clinic

    Marietta, Georgia, 30188

  • Clinical Research Institute of Southern Oregon, PC

    Medford, Oregon, 97504

  • Allergy and Asthma Associates of Southern California

    Mission Viejo, California, 92691

  • Central Texas Health Research

    New Braunfels, Texas, 78130

  • Sneeze, Weeze, & Itch Associates

    Normal, Illinois, 61761

  • Atlantic Research Center, LLC

    Ocean City, New Jersey, 07712

  • Creighton University Medical Center

    Omaha, Nebraska, 68131

  • CHOC, PSF, AMC, Division of Allergy, Asthma, and Immunology

    Orange, California, 92868

  • Center for Clinical Trials, LLC

    Paramount, California, 90723

  • ACRC Trials

    Plano, Texas, 75024

  • North Texas Family Medicine

    Plano, Texas, 75093

  • Clinical Research Institute

    Plymouth, Minnesota, 55441

  • Allergy Associates Research Center

    Portland, Oregon, 97202

  • Asthma, Nasal Disease & Allergy Research Center of New England

    Providence, Rhode Island, 02906

  • North Carolina Clinical Research

    Raleigh, North Carolina, 27607

  • Peninsula Research Associates

    Rolling Hills Estates, California, 90274

  • Capital Allergy & Respiratory Disease Center

    Sacramento, California, 95819

  • Benchmark Research

    San Angelo, Texas, 76904

  • Sun Research Institute

    San Antonio, Texas, 78215

  • DCT - Barlite Dba Discovery Clinical Trials

    San Antonio, Texas, 78224

  • Allergy and Asthma Research Center, PA

    San Antonio, Texas, 78229

  • San Antonio Ear, Nose & Throat Research

    San Antonio, Texas, 78229

  • Sylvana Research Associates

    San Antonio, Texas, 78229

  • DCT-Westover Hills, Dba Discovery Clinical Trials

    San Antonio, Texas, 78251

  • Allergy Associates Medical Group

    San Diego, California, 92120

  • Allergy & Asthma Medical Group and Research Center, APC

    San Diego, California, 92123

  • Aeroallergy Research Laboratories of Savannah, Inc

    Savannah, Georgia, 31406

  • Spartanburg Medical Research

    Spartanburg, South Carolina, 29303

  • Clinical Research Atlanta

    Stockbridge, Georgia, 30281

  • Bensch Research Associates

    Stockton, California, 95207

  • Toledo Center for Clinical Research

    Sylvania, Ohio, 43560

  • Pediatric Healthcare of Northwest Houston

    Tomball, Texas, 77375

  • Asthma and Allergy Research Associates

    Upland, Pennsylvania, 19013

  • Allergy & Asthma Care of Waco

    Waco, Texas, 76712

  • Allergy Asthma Research Institute

    Waco, Texas, 76712

Other trials in United States

About this study

Official title: A 2-Week Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6 to 11 Years With Seasonal Allergic Rhinitis

This is a 2-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and premenarchal female subjects 6 to 11 years-old diagnosed with SAR.

Read the detailed description

This is a 2-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and premenarchal female subjects 6 to 11 years-old diagnosed with SAR.

This study will consist of the following:

Screening, Single-blind Placebo Run-in period, Double-blind Treatment period (during this period, subjects will be randomized to double-blind treatment with either ciclesonide nasal aerosol 37 mcg or 74 mcg or placebo for 2 weeks of treatment) and Follow-up. The total duration of subject participation will be approximately 2 months.

Being tested
Ciclesonide nasal aerosol 37 mcg, ciclesonide nasal aerosol 74 mcg, Placebo
Keywords
Seasonal Allergic Rhinitis, Ciclesonide, Ciclesonide Nasal Aerosol
Medical subject headings
Rhinitis, Allergic, Seasonal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ciclesonide nasal aerosol 37 mcgDrug

    ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg

  • ciclesonide nasal aerosol 74 mcgDrug

    ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg

  • PlaceboDrug

    Placebo - one actuation per nostril

Study groups in NCT01458275
Study groupRoleWhat they receive
ciclesonide nasal aerosol 37mcgActive comparatorciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
Receives: Drug: Ciclesonide nasal aerosol 37 mcg
ciclesonide nasal aerosol 74 mcgActive comparatorciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
Receives: Drug: ciclesonide nasal aerosol 74 mcg
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Average Daily Subject Reported AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Over the 2-week Double-blind 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.

    Measured: Weeks 0 - 2

Secondary outcomes (11)

  1. Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Nasal Symptom Scores (iTNSS) Over the 2-week Double-blind 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, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

    Measured: Weeks 0 - 2

  2. Change From Baseline in Average Daily Subject-reported AM and PM Reflective Total Ocular Symptom Scores (rTOSS) Over the 2-week Double-blind Treatment Period.

    TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:

    0 = absent

    1. = mild
    2. = moderate
    3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess 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.

    Measured: Weeks 0 - 2

  3. Change From Baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score at the End of the Double-blind Treatment Period.

    PRQLQ was developed to measure the functional problems (physical, emotional, and social) that are most troublesome to children with rhinoconjunctivitis. The PRQLQ has 23 questions in 5 domains (nose symptoms, eye symptoms, practical problems, activity limitation, and other symptoms). Children recalled how they were during the previous week and responded to each question on a 7-point scale (0 = not bothered to 6 = extremely bothered or 0 = none of the time to 6 = all of the time) for a total possible score of 138. The overall PRQLQ score is the mean of all 23 responses and the individual domain scores are the means of the items in those domains.

    Measured: Weeks 0 - 2

  4. Change From Baseline in Average Daily Subject Reported AM Instantaneous Total Nasal Symptom Scores (iTNSS) Over the 2-week Double-blind Treatment Period

    TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions assessed in the AM. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe in the AM. Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

    Measured: Weeks 0 - 2

  5. Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Ocular Symptom Scores (iTOSS) Over the 2-week Double-blind Treatment Period.

    TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:

    0 = absent

    1. = mild
    2. = moderate
    3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement

    Measured: Weeks 0 - 2

  6. Time to Maximal Effect in the AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Over the 2-week Double-blind Treatment Period

    The time to maximal effect, defined as the number of days until the first treatment day on which the estimated difference between ciclesonide nasal aerosol and placebo was at least 90% of the largest estimated difference, was based on the analyses of change from baseline in the average of AM and PM rTNSS scores for each day. The time to achieve at least 90% of these estimated differences is presented.

    Measured: Weeks 0 - 2

  7. Number of Subjects Experiencing Treatment-emergent AEs

    Treatment-Emergent Adverse Events Occurring in ≥ 2% of Subjects in Any Treatment Group (ITT Population)

    Measured: Weeks 0 - 3

  8. Percentage of Subjects Experiencing Treatment-emergent AEs

    Treatment-Emergent Adverse Events Occurring in ≥ 2% of Subjects in Any Treatment Group (ITT Population)

    Measured: Weeks 0 - 3

  9. Treatment-emergent AEs Causing Study Medication Discontinuation

    Measured: Weeks 0 - 3

  10. Number of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation

    Measured: Weeks 0 - 3

  11. Percentage of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation

    Measured: Weeks 0 - 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionMar 2013
  4. Study completionMar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
847 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01458275
Sponsor's protocol ID
SEP060-305
Status last verified
Apr 2014
First submitted
20 Oct 2011
Last updated
15 May 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ciclesonide nasal aerosol 37 mcg and ciclesonide nasal aerosol 74 mcg in people with Seasonal Allergic Rhinitis, run by Sumitomo Pharma America, Inc. at 66 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Average Daily Subject Reported AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Over the 2-week Double-blind Treatment Period (time frame: Weeks 0 - 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01458275.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2014.

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