AzTrials
AzTrials

Rhinitis, Allergic, SeasonalPhase 2NCT00807053

Dose-ranging Study to Assess the Efficacy and Safety of Ciclesonide HFA Nasal Aerosol in Adult and Adolescent Patients 12 Years and Older With Seasonal Allergic Rhinitis (SAR) (BY9010/M1-602)

A Phase 2 study testing Ciclesonide HFA in people with Rhinitis, Allergic, Seasonal, run by AstraZeneca at 31 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

The primary objective of this study is to demonstrate the efficacy of ciclesonide HFA, applied as a nasal aerosol once daily, in patients with SAR. The secondary objectives are to evaluate Quality-of-Life and safety. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Rhinitis, Allergic, Seasonal
What is being tested?
Ciclesonide HFA
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
480 participants
Where
31 sitesUnited States
Study dates
Apr 2007to Jul 2007
Phase
Phase 2
Are there results?
None posted in the registry

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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Male or female 12 years and older
  • General good health, and free of any concomitant conditions or treatment that could interfere with study conduct,influence the interpretation of study observations/results, or put the patient at increases risk during the trial
  • A history of SAR to relevant seasonal allergen for a minimum of two years immediately preceding the study season. The SAR must have been of sufficient severity to have required treatment (continuous or intermittent) in the past and in the investigator´s judgment - is expected to require treatment throughout the entire study period
  • A demonstrated sensitivity to grass or tree pollen known to induce SAR through a standard skin prick test. A positive test is defined as a wheal diameter at least 3 mm larger than the control wheal for the skin prick test. Documentation of a positive result 12 months prior to screening is acceptable
  • Female is of child-bearing potential and is currently taking 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). Women of childbearing potential, or less than 1 year postmenopausal, will require a negative pregnancy test at the Screnning Visit (B0) as well as at last on-treatment (T2)
  • Capable of understanding the requirements, risks and benefits of study participation, and, as judged by the investigator, capable of giving informed consent and compliance with all study requirements (visits, record-keeping, etc.)

Who cannot join

  • Pregnancy, nursing or plans to become pregnant or donate gametes (over a sperm) for in vitro fertilization during the study period or for 30 days following the study period.
  • History of physical findings of nasal pathology, including nasal polyps (within the last 60 days) or other clinically significant respiratory tract malformations, recent nasal biopsy (within the last 60 days), nasal trauma, or surgery and atrophic rhinitis or rhinitis medicamentosa (within the last 60 days)
  • Participation in any investigational drug trial within the 30 days preceding the Screening Visit (B0)
  • A known hypersensitivity to any corticosteroid or any of the excipients in the formulation
  • History of a respiratory infection or disorder (including, but not limited to bronchitis, pneumonia, the common cold, acute or chronic sinusitis, flu, severe acute respiratory syndrome (SARS)) within the 14 days preceding the Screening Visit (B0), or development of a respiratory infection during the Baseline Period.
  • History of alcohol or drug abuse within the preceding two years
Show all 16Show fewer
  • History of a positive test of HIV, hepatitis B or hepatitis C
  • Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of ß-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 ß-agonists is acceptable
  • Plans to travel outside the study area (the known pollen area for the investigative site) for two or more consecutive days OR 5 or more days total starting from 7 days prior to Randomization Visit (T0) until the final Treatment Visit (T2)
  • Use of any prohibited concomitant medications within the prescribed (per protocol) time since last dose period prior to the Screening Visit (B0) and during entire treatment duration.
  • Use of antibiotic therapy for acute conditions within 14 days prior to the Screening Visit (B0). 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 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 (B0) 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 (B0).
  • Use of topical corticosteroids in concentrations in excess of 1% hydrocortisone or equivalent within 30 days prior to the Screening Visit (B0); 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 Screening Visit (B0) AND use of a stable (maintenance) dose during the study period may be considered for inclusion.

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

United States31 sites

  • Altana/Nycomed

    Ashland, Oregon, 97520

  • Altana/Nycomed

    Austin, Texas, 78750

  • Altana/Nycomed

    Bethesda, Maryland, 20814

  • Altana/Nycomed

    Blue Bell, Pennsylvania, 19422

  • Altana/Nycomed

    Burke, Virginia, 22015

  • Altana/Nycomed

    Charleston, South Carolina, 29414

  • Altana/Nycomed

    Colorado Springs, Colorado, 80907

  • Altana/Nycomed

    Denver, Colorado, 80230

  • Altana/Nycomed

    Draper, Utah, 84020

  • Altana/Nycomed

    Gainsville, Georgia, 30501

  • Altana/Nycomed

    Indianapolis, Indiana, 46208

  • Altana/Nycomed

    Lincoln, Nebraska, 68505

  • Altana/Nycomed

    Medford, Oregon, 97504

  • Altana/Nycomed

    Minneapolis, Minnesota, 55402

  • Altana/Nycomed

    Mission Viejo, California, 92691

  • Altana/Nycomed

    New Braunfels, Texas, 78130

  • Altana/Nycomed

    Orange, California, 92868

  • Altana/Nycomed

    Overland Park, Kansas, 66210

  • Altana/Nycomed

    Papillion, Nebraska, 68046

  • Altana/Nycomed

    Pittsburgh, Pennsylvania, 15241

  • Altana/Nycomed

    Portland, Oregon, 97213

  • Altana/Nycomed

    Raleigh, North Carolina, 27607

  • Altana/Nycomed

    Richmond, Virginia, 23226

  • Altana/Nycomed

    San Antonio, Texas, 78229

  • Altana/Nycomed

    San Diego, California, 92123

  • Altana/Nycomed

    Savannah, Georgia, 31406

  • Altana/Nycomed

    Skillman, New Jersey, 08558

  • Altana/Nycomed

    St Louis, Missouri, 63141

  • Altana/Nycomed

    Stockbridge, Georgia, 30281

  • Altana/Nycomed

    Upland, Pennsylvania, 19013

  • Altana/Nycomed

    West Brick, New Jersey, 08724

Other trials in United States

About this study

Official title: A Double-blind, Randomized, Placebo-controlled, Parallel Group, Multicenter, Dose-ranging Study to Assess the Efficacy and Safety of Ciclesonide HFA Nasal Aerosol in Adult and Adolescent Patients 12 Years and Older With Seasonal Allergic Rhinitis (SAR)

The primary objective of this study is to demonstrate the efficacy of ciclesonide HFA, applied as a nasal aerosol once daily, in patients with SAR. The secondary objectives are to evaluate Quality-of-Life and safety.

Being tested
Ciclesonide HFA, Placebo
Keywords
Seasonal Allergic Rhinitis, Ciclesonide, SAR
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 HFADrug

    75 mcg Ciclesonide HFA versus Placebo

  • Ciclesonide HFADrug

    150 mcg Ciclesonide HFA versus Placebo

  • Ciclesonide HFADrug

    300 mcg Ciclesonide HFA versus Placebo

  • PlaceboDrug

    Placebo

Study groups in NCT00807053
Study groupRoleWhat they receive
1Active comparatorCiclesonide HFA 75 mcg (37,5 mcg / actuation, 1 actuation/nostril), once daily
Receives: Drug: Ciclesonide HFA
2Active comparatorCiclesonide HFA 150 mcg (75 mcg / actuation, 1 actuation/nostril), once daily
Receives: Drug: Ciclesonide HFA
3Active comparatorCiclesonide HFA 300 mcg (150 mcg / actuation, 1 actuation/nostril), once daily
Receives: Drug: Ciclesonide HFA
4Placebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

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

  1. Average of AM and PM patient-reported reflective Total Nasal Symptom Score (TNSS) over the first two weeks of treatment

    Measured: 2 weeks

Secondary outcomes (3)

  1. Average of AM and PM patient-reported instantaneous TNSS over the first two weeks of treatment

    Measured: 2 weeks

  2. Physician-assessed total nasal symptoms score (PNSS) over the treatment period

    Measured: 4 weeks

  3. Rhinoconjunctivitis Quality of Life Questionaire (RQLQ) over the treatment period in patients (adolescents and adults) with impaired quality of life at Baseline defined as a RQLQ score of greater than 3.0

    Measured: 4 weeks

Timeline

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

  1. First posted11 Dec 2008 (estimated)
  2. Study startApr 2007
  3. Primary completionJun 2007
  4. Study completionJul 2007

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
480 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00807053
Sponsor's protocol ID
BY9010/M1-602
Status last verified
Sep 2016
First submitted
10 Dec 2008
Last updated
5 Dec 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ciclesonide HFA in people with Rhinitis, Allergic, Seasonal, run by AstraZeneca at 31 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 16 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 5 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Average of AM and PM patient-reported reflective Total Nasal Symptom Score (TNSS) over the first two weeks of treatment (time frame: 2 weeks). 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 NCT00807053.

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 5 Dec 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in