Seasonal Allergic RhinitisPhase 2NCT00940953
Compare Captisol-Enabled (CE) Budesonide + Azelastine Nasal Solution and Rhinocort Aqua + Astelin in an Environmental Exposure Chamber (EEC) Study of Allergic Rhinitis
A Phase 2 study testing Budesonide + Azelastine in people with Seasonal Allergic Rhinitis, run by Ligand Pharmaceuticals at 1 site in Canada.
Trial summary
The primary objective of this study was to compare Placebo to Captisol-Enabled Budesonide + Azelastine in a single spray and two separate sprays (Budesonide + Azelastine) in patients with Seasonal Allergic Rhinitis exposed to controlled ragweed pollen. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Budesonide + Azelastine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2008to May 2008
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have a clinical history of SAR
- Adults (males and females) aged 18 to 65
- Patients must have documentation of a positive skin test within 12 months of screening to ragweed allergen defined by a positive case history and a positive skin prick and/or intradermal test for ragweed allergen.
- Non-pregnant, non-lactating females, or women who are post-menopausal or are naturally or surgically sterile
- Females of childbearing potential must have a confirmed absence of pregnancy according to a negative urine pregnancy test and must be using acceptable birth control methods
- In generally good health on the basis of medical history and physical examination.
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- Willingness to attend all study visits.
- Capable of following and understanding instructions.
- Willing and able to provide written informed consent prior to initiation of any study procedures, including initiation of washout of any concomitant medications
Who cannot join
- Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in-vitro fertilization
- Have clinically significant physical findings of nasal anatomical deformities causing greater than 50% obstruction based on the clinical estimate of the investigator, including nasal polyps, septal defects or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma, or surgery and atrophic rhinitis or rhinitis medicamentosa
- Previous participation in a budesonide study within 1 month prior to the Screening Visit.
- Currently participating in a clinical trial or has been exposed to an investigational treatment within the 30 days prior to the Screening Visit.
- A known hypersensitivity to any corticosteroid or any of the excipients in the formulation of the investigational drug (e.g., any adverse experience with budesonide, azelastine or the Captisol-containing products Vfend IV or Geodon IM).
- History of severe respiratory infection or disorder
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- History of alcohol or drug abuse
- History of a positive test for HIV, hepatitis B or hepatitis C.
- Use of any of the prohibited medications within the identified exclusion periods
- Use of antibiotic therapy for acute conditions
- Initiation of immunotherapy or dose escalation during the study period.
- Non-vaccinated exposure to or active infection with chickenpox or measles within the 21 days preceding the Screening Visit.
- Exposure to systemic corticosteroids
- Use of topical corticosteroids in concentrations in excess of 1% hydrocortisone or equivalent
- History of epilepsy or seizures
- History of coronary heart disease, uncontrolled hypertension, or other clinically significant cardiovascular disease.
- Have any of the following conditions that are judged by the investigator to be clinically significant and/or affect the patient's ability to participate in the clinical trial:
- Impaired hepatic function including alcohol related liver disease or cirrhosis
- History of ocular disturbances (e.g., glaucoma or posterior subcapsular cataracts)
- Any systemic infection
- Hematological, renal, endocrine (except for controlled diabetes mellitis or postmenopausal symptoms or hypothyroidism)
- Gastrointestinal disease
- Malignancy (excluding basal cell carcinoma)
- A current neuropsychiatric condition with or without drug therapy
Trial locations and contacts
1 site in 1 country.
Canada1 site
Allied Research International - Cetero Research
Mississauga, Ontario, L4W 1N2
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, 3-Way Cross-Over Study Comparing Relative Efficacy of CE Budesonide+Azelastine & Rhinocort Aqua+Astelin Nasal Sprays Against Placebo in the Treatment of AR in an EEC Model
The primary objective of this study was to compare Placebo to Captisol-Enabled Budesonide + Azelastine in a single spray and two separate sprays (Budesonide + Azelastine) in patients with Seasonal Allergic Rhinitis exposed to controlled ragweed pollen.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Budesonide + Azelastine, Placebo
- 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.
Budesonide + AzelastineDrug
Also called CDX-313, Captisol
nasal spray, one spray per nostril at time 0 plus one spray Placebo
Budesonide + AzelastineDrug
Also called Rhinocort Aqua, Astelin
nasal spray, one spray of each per nostril at time 0
PlaceboDrug
Also called phosphate buffered saline solution
nasal spray, one spray per nostril from each of 2 bottles at time 0
| Study group | Role | What they receive |
|---|---|---|
| Captisol-Enabled Budesonide + Azelastine | Experimental | Not described Receives: Drug: Budesonide + Azelastine |
| Rhinocort Aqua+Astelin | Active comparator | Not described Receives: Drug: Budesonide + Azelastine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-rated Total Nasal Symptom Score
Measured: 10 mins, 20 mins, 30 mins, 40 mins, 60 mins, 90 mins, 120 mins and then every hour up to 10 hours post dose
Secondary outcomes (2)
Patient-rated Total Symptom Score
Measured: 10 mins, 20 mins, 30 mins, 40 mins, 60 mins, 90 mins, 120 mins and then every hour up to 10 hours post dose
Patient-rated EEC-RQLQ assessment
Measured: -0.75 hours, 2 hours, 6 hours and 10 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2009 (estimated)
- Study startFeb 2008
- Primary completionMay 2008
- Study completionMay 2008
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.
- 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ligand Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Deepen Patel, MD, Principal investigator, Allied Research International - Cetero Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00940953
- Sponsor's protocol ID
- CDX313CT001
- Other IDs
- P2DS07001
- Status last verified
- Oct 2012
- First submitted
- 15 Jul 2009
- Last updated
- 4 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, 3-Way Cross-Over Study Comparing Relative Efficacy of CE Budesonide+Azelastine & Rhinocort Aqua+Astelin Nasal Sprays Against Placebo in the Treatment of AR in an EEC Model
- ClinicalTrials.gov ID
- NCT00940953
- Acronym / sponsor ID
- CDX313CT001
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Ligand PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 17 Jul 2009 (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 primary objective of this study was to compare Placebo to Captisol-Enabled Budesonide + Azelastine in a single spray and two separate sprays (Budesonide + Azelastine) in patients with Seasonal Allergic Rhinitis exposed to controlled ragweed pollen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Captisol-Enabled Budesonide + Azelastine | Experimental | Drug: Budesonide + Azelastine |
| Rhinocort Aqua+Astelin | Active comparator | Drug: Budesonide + Azelastine |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must have a clinical history of SAR
- Adults (males and females) aged 18 to 65
- Patients must have documentation of a positive skin test within 12 months of screening to ragweed allergen defined by a positive case history and a positive skin prick and/or intradermal test for ragweed allergen.
- Non-pregnant, non-lactating females, or women who are post-menopausal or are naturally or surgically sterile
- Females of childbearing potential must have a confirmed absence of pregnancy according to a negative urine pregnancy test and must be using acceptable birth control methods
Key exclusion criteria (24 listed)
- Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in-vitro fertilization
- Have clinically significant physical findings of nasal anatomical deformities causing greater than 50% obstruction based on the clinical estimate of the investigator, including nasal polyps, septal defects or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma, or surgery and atrophic rhinitis or rhinitis medicamentosa
- Previous participation in a budesonide study within 1 month prior to the Screening Visit.
- Currently participating in a clinical trial or has been exposed to an investigational treatment within the 30 days prior to the Screening Visit.
- A known hypersensitivity to any corticosteroid or any of the excipients in the formulation of the investigational drug (e.g., any adverse experience with budesonide, azelastine or the Captisol-containing products Vfend IV or Geodon IM).
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 |
|---|---|---|
| Budesonide + AzelastineAlso: CDX-313, Captisolnasal spray, one spray per nostril at time 0 plus one spray Placebo | Drug | Captisol-Enabled Budesonide + Azelastine |
| Budesonide + AzelastineAlso: Rhinocort Aqua, Astelinnasal spray, one spray of each per nostril at time 0 | Drug | Rhinocort Aqua+Astelin |
| PlaceboAlso: phosphate buffered saline solutionnasal spray, one spray per nostril from each of 2 bottles at time 0 | Drug | Placebo |
Primary outcome
Patient-rated Total Nasal Symptom Score
Time frame: 10 mins, 20 mins, 30 mins, 40 mins, 60 mins, 90 mins, 120 mins and then every hour up to 10 hours post dose
2 secondary outcomes
Patient-rated Total Symptom Score
Time frame: 10 mins, 20 mins, 30 mins, 40 mins, 60 mins, 90 mins, 120 mins and then every hour up to 10 hours post dose
Patient-rated EEC-RQLQ assessment
Time frame: -0.75 hours, 2 hours, 6 hours and 10 hours post dose
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 4 Oct 2012.
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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.
Deepen Patel, MD principal investigator
Allied Research International - Cetero Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Budesonide + Azelastine in people with Seasonal Allergic Rhinitis, run by Ligand Pharmaceuticals at 1 site in Canada.
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 9 inclusion and 24 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 4 Oct 2012. 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 Canada. 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?
Patient-rated Total Nasal Symptom Score (time frame: 10 mins, 20 mins, 30 mins, 40 mins, 60 mins, 90 mins, 120 mins and then every hour up to 10 hours post dose). 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 4 Oct 2012.