Seasonal Allergic RhinitisPhase 3NCT00641680
Rhinocort Aqua Versus Placebo and Fluticasone Propionate
A Phase 3 study testing Budesonide and Fluticasone propionate in people with Seasonal Allergic Rhinitis, run by AstraZeneca.
Trial summary
The purpose of this study is to compare once daily treatment with Rhinocort against placebo and Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Budesonide and Fluticasone propionate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 750 participants
- Where
- No sites listed yet
- Study dates
- Apr 2003to Jul 2003
- Phase
- Phase 3
- 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
- At least a 2 year documented history of seasonal allergic rhinitis
- who, in the opinion of the investigator,
- is a candidate for treatment with nasal steroids based on a history of either
- a)inadequate control of symptoms with antihistamines, decongestants and/or immunotherapy, or
- b) prior successful treatment with nasal steroids.
- A positive response to a skin prick test at Visit 1 or within the last 12 months for grass allergens that must be present in the subject's environment for the duration of the study.
Who cannot join
- Primary or secondary adrenal insufficiency
- Nasal candidiasis, rhinitis medicamentosa, acute or chronic sinusitis, influenza, upper respiratory tract infection or structural abnormalities of the nose (e.g., septal deviation, nasal polyps) symptomatic enough to cause significant nasal obstruction as judged by the investigator.
- A diagnosis of asthma requiring treatment as specifies in the protocol.
About this study
Official title: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-group, Phase IIIb Study to Assess the Efficacy, Safety & Product Attributes of Rhinocort Aqua(Budesonide) Versus Placebo and FluticasonePropionate as an Active Comparator in Patients 12yrs Age &Older With SeasonalAllergicRhinitis
The purpose of this study is to compare once daily treatment with Rhinocort against placebo and Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Budesonide, Fluticasone propionate, Placebo
- Keywords
- Seasonal allergic rhinitis, Nasal symptoms, Congestion, Rhinorrhea, Sneeze, budesonide, Rhinocort AQUA, Fluticasone propionate, Flonase
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Rhinorrhea, Sneezing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BudesonideDrug
Also called Rhinocort AQUA
Fluticasone propionateDrug
Also called Flonase®
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Budesonide Receives: Drug: Budesonide |
| 2 | Active comparator | Fluticasone propionate Receives: Drug: Fluticasone propionate |
| 3 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare once daily treatment with Rhinocort against placebo and at reliving the nasal symptoms of seasonal allergic rhinitis.
Measured: 2 weeks
Secondary outcomes (3)
To compare once daily treatment with Rhinocort against Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.
Measured: 2 weeks
To compare once daily treatment with placebo against Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.
Measured: 2 weeks
Safety assessment via adverse events and clinical measurements.
Measured: 2 & 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startApr 2003
- Primary completionJul 2003
- Study completionJul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael E Ruff, MD, Principal investigator, Pharmaceutical Research, Dallas, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00641680
- Sponsor's protocol ID
- D5360C00005
- Status last verified
- Jan 2011
- First submitted
- 18 Mar 2008
- Last updated
- 24 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-group, Phase IIIb Study to Assess the Efficacy, Safety & Product Attributes of Rhinocort Aqua(Budesonide) Versus Placebo and FluticasonePropionate as an Active Comparator in Patients 12yrs Age &Older With SeasonalAllergicRhinitis
- ClinicalTrials.gov ID
- NCT00641680
- Acronym / sponsor ID
- D5360C00005
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- Seasonal allergic rhinitis, Nasal symptoms, Congestion, Rhinorrhea, Sneeze, budesonide, Rhinocort AQUA, Fluticasone propionate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Primary completion
- Jul 2003 (actual)
- Study completion
- Jul 2003 (actual)
- First posted
- 24 Mar 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 compare once daily treatment with Rhinocort against placebo and Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: BudesonideBudesonide |
| 2 | Active comparator | Drug: Fluticasone propionateFluticasone propionate |
| 3 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- At least a 2 year documented history of seasonal allergic rhinitis
- who, in the opinion of the investigator,
- is a candidate for treatment with nasal steroids based on a history of either
- A positive response to a skin prick test at Visit 1 or within the last 12 months for grass allergens that must be present in the subject's environment for the duration of the study.
Key exclusion criteria (3 listed)
- Primary or secondary adrenal insufficiency
- Nasal candidiasis, rhinitis medicamentosa, acute or chronic sinusitis, influenza, upper respiratory tract infection or structural abnormalities of the nose (e.g., septal deviation, nasal polyps) symptomatic enough to cause significant nasal obstruction as judged by the investigator.
- A diagnosis of asthma requiring treatment as specifies in the protocol.
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 |
|---|---|---|
| BudesonideAlso: Rhinocort AQUA | Drug | 1 |
| Fluticasone propionateAlso: Flonase® | Drug | 2 |
| Placebo | Drug | 3 |
Primary outcome
To compare once daily treatment with Rhinocort against placebo and at reliving the nasal symptoms of seasonal allergic rhinitis.
Time frame: 2 weeks
3 secondary outcomes
To compare once daily treatment with Rhinocort against Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.
Time frame: 2 weeks
To compare once daily treatment with placebo against Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.
Time frame: 2 weeks
Safety assessment via adverse events and clinical measurements.
Time frame: 2 & 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2011.
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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.
Michael E Ruff, MD principal investigator
Pharmaceutical Research, Dallas, USA
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Budesonide and Fluticasone propionate in people with Seasonal Allergic Rhinitis, run by AstraZeneca.
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 3 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 24 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
To compare once daily treatment with Rhinocort against placebo and at reliving the nasal symptoms of seasonal allergic rhinitis. (time frame: 2 weeks). 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 24 Jan 2011.