Allergic RhinitisPhase 4NCT00793858
A Pilot Investigation of Ciclesonide When Administered as a Hypotonic Versus an Isotonic Formulation of Ciclesonide Nasal Spray
A Phase 4 study of Allergic Rhinitis, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to measure the amount of a nasal steroid spray (ciclesonide) absorbed by the tissue in the nose 2 hours after having this study drug sprayed in the nose Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinitis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Sep 2009
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females 18 years of age or older.
- History of perennial allergic rhinitis for at least 1 year prior to screening.
- Positive skin test to perennial allergen.
Who cannot join
- Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
- Pregnant or lactating women.
- Upper respiratory infection within 14 days of study start.
- Active asthma requiring treatment with inhaled or systemic steroids.
- Use of any form of nasal spray during the previous month.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
Official title: A Pilot Investigation of the Nasal Mucosal Absorption, Retention, and Metabolism of Ciclesonide When Administered as a Hypotonic Versus an Isotonic Formulation of Ciclesonide Nasal Spray When Each Formulation Is Administered to Currently Symptomatic Patients (18 Years or Older) With Documented Perennial Allergic Rhinitis (PAR).
The purpose of this study is to measure the amount of a nasal steroid spray (ciclesonide) absorbed by the tissue in the nose 2 hours after having this study drug sprayed in the nose
- Conditions
- Allergic Rhinitis
- Being tested
- placebo, isotonic ciclesonide, hypotonic ciclesonide
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placebo, isotonic ciclesonide, hypotonic ciclesonideDrug
200mcg/nostril
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | placebo in left nostril, isotonic ciclesonide in right Receives: Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide |
| 2 | Active comparator | hypotonic ciclesonide in left nostril, placebo in right Receives: Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide |
| 3 | Active comparator | hypotonic ciclesonide in right and left nostrils Receives: Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide |
| 4 | Active comparator | isotonic ciclesonide in both right and left nostrils Receives: Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide |
| 6 | Placebo comparator | placebo in both right and left nostrils Receives: Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide |
| 5 | Active comparator | isotonic ciclesonide in left nostril and hypotonic ciclesonide in right Receives: Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
levels of ciclesonide in biopsy tissue
Measured: 2 hours post study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startFeb 2009
- Primary completionSep 2009 (estimated)
Why it stopped: Cost prohibitive and company withdrew support.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Sumitomo Pharma America, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00793858
- Sponsor's protocol ID
- 16651A (SEP 1)
- Status last verified
- Jun 2013
- First submitted
- 14 Nov 2008
- Last updated
- 7 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Investigation of the Nasal Mucosal Absorption, Retention, and Metabolism of Ciclesonide When Administered as a Hypotonic Versus an Isotonic Formulation of Ciclesonide Nasal Spray When Each Formulation Is Administered to Currently Symptomatic Patients (18 Years or Older) With Documented Perennial Allergic Rhinitis (PAR).
- ClinicalTrials.gov ID
- NCT00793858
- Acronym / sponsor ID
- 16651A (SEP 1)
- Conditions
- Allergic Rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Cost prohibitive and company withdrew support.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Sumitomo Pharma America, Inc.
- Study start
- Feb 2009
- Primary completion
- Sep 2009 (estimated)
- First posted
- 19 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to measure the amount of a nasal steroid spray (ciclesonide) absorbed by the tissue in the nose 2 hours after having this study drug sprayed in the nose
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: placebo, isotonic ciclesonide, hypotonic ciclesonideplacebo in left nostril, isotonic ciclesonide in right |
| 2 | Active comparator | Drug: placebo, isotonic ciclesonide, hypotonic ciclesonidehypotonic ciclesonide in left nostril, placebo in right |
| 3 | Active comparator | Drug: placebo, isotonic ciclesonide, hypotonic ciclesonidehypotonic ciclesonide in right and left nostrils |
| 4 | Active comparator | Drug: placebo, isotonic ciclesonide, hypotonic ciclesonideisotonic ciclesonide in both right and left nostrils |
| 6 | Placebo comparator | Drug: placebo, isotonic ciclesonide, hypotonic ciclesonideplacebo in both right and left nostrils |
| 5 | Active comparator | Drug: placebo, isotonic ciclesonide, hypotonic ciclesonideisotonic ciclesonide in left nostril and hypotonic ciclesonide in right |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females 18 years of age or older.
- History of perennial allergic rhinitis for at least 1 year prior to screening.
- Positive skin test to perennial allergen.
Key exclusion criteria (5 listed)
- Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
- Pregnant or lactating women.
- Upper respiratory infection within 14 days of study start.
- Active asthma requiring treatment with inhaled or systemic steroids.
- Use of any form of nasal spray during the previous month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placebo, isotonic ciclesonide, hypotonic ciclesonide200mcg/nostril | Drug | 1, 2, 3, 4, 5, 6 |
Primary outcome
levels of ciclesonide in biopsy tissue
Time frame: 2 hours post study drug administration
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Allergic Rhinitis, run by University of Chicago at 1 site 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 3 inclusion and 5 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: withdrawn, as of the sponsor's last update on 7 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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?
levels of ciclesonide in biopsy tissue (time frame: 2 hours post study drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jun 2013.