Seasonal Allergic RhinitisPhase 2NCT00641979
New Nasal Applicator / New Formulation - User Study
A Phase 2 study testing budesonide in people with Seasonal Allergic Rhinitis, run by AstraZeneca.
Trial summary
The purpose of this study is to compare the efficacy of once daily dosing with Rhinocort Aqua (new formulation) against Rhinocort Aqua (current formulation) and placebo in reliving the symptoms of seasonal allergic rhinitis (SAR). Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- budesonide
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Apr 2002to Aug 2002
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 documented history of at least one year of seasonal allergic rhinitis.
- A positive response to a skin prick test for grass allergens that must be present in the subject's environment throughout 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 specified in the protocol.
About this study
Official title: A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Functionality of a New Nasal Device With Reformulated Rhinocort Aqua (Budesonide) Versus the Current Product and Versus Placebo in Subjects With Seasonal Allergic Rhinitis (SAR).
The purpose of this study is to compare the efficacy of once daily dosing with Rhinocort Aqua (new formulation) against Rhinocort Aqua (current formulation) and placebo in reliving the symptoms of seasonal allergic rhinitis (SAR).
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- budesonide, Placebo
- Keywords
- Allergic rhinitis, Nasal symptoms, Congestion, Rhinorrhea, Sneeze, budesonide, Rhinocort AQUA
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, 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
Current product
BudesonideDevice
Also called Rhinocort Aqua
New type device
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Rhinocort Receives: Drug: budesonide; Device: Budesonide |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Total Nasal Symptom scores (Rhinorrhea, Congestion, Itching & Sneezing)
Measured: 2 weekly
Secondary outcomes (2)
Durability of device
Measured: End of study
Safety assessment via adverse events and clinical measurements
Measured: 2 weekly
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 2002
- Primary completionAug 2002
- Study completionAug 2002
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Shaile Shah, MD, Principal investigator, Allergy & Asthma Consultant, NJ, USA.Bertil Andersson, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00641979
- Sponsor's protocol ID
- SD-005-0698
- Other IDs
- D5360C00698
- 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 Study to Assess the Efficacy, Safety, and Functionality of a New Nasal Device With Reformulated Rhinocort Aqua (Budesonide) Versus the Current Product and Versus Placebo in Subjects With Seasonal Allergic Rhinitis (SAR).
- ClinicalTrials.gov ID
- NCT00641979
- Acronym / sponsor ID
- SD-005-0698
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- Allergic rhinitis, Nasal symptoms, Congestion, Rhinorrhea, Sneeze, budesonide, Rhinocort AQUA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2002
- Primary completion
- Aug 2002 (actual)
- Study completion
- Aug 2002 (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 the efficacy of once daily dosing with Rhinocort Aqua (new formulation) against Rhinocort Aqua (current formulation) and placebo in reliving the symptoms of seasonal allergic rhinitis (SAR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: budesonide, Device: BudesonideRhinocort |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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 documented history of at least one year of seasonal allergic rhinitis.
- A positive response to a skin prick test for grass allergens that must be present in the subject's environment throughout 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 specified 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 AQUACurrent product | Drug | 1 |
| BudesonideAlso: Rhinocort AquaNew type device | Device | 1 |
| Placebo | Drug | 2 |
Primary outcome
Assessment of Total Nasal Symptom scores (Rhinorrhea, Congestion, Itching & Sneezing)
Time frame: 2 weekly
2 secondary outcomes
Durability of device
Time frame: End of study
Safety assessment via adverse events and clinical measurements
Time frame: 2 weekly
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.
Shaile Shah, MD principal investigator
Allergy & Asthma Consultant, NJ, USA.
Bertil Andersson study director
AstraZeneca
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing budesonide 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 3 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 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?
Assessment of Total Nasal Symptom scores (Rhinorrhea, Congestion, Itching & Sneezing) (time frame: 2 weekly). 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.