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Seasonal Allergic RhinitisPhase 2NCT00938613

Compare CE-Budesonide Nasal Solution & Rhinocort Aqua in an EEC Study of AR

A Phase 2 study testing Budesonide in people with Seasonal Allergic Rhinitis, run by Ligand Pharmaceuticals at 1 site in Canada.

Completed

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

Official record
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Trial summary

The primary objective of this study was to compare the relative efficacy of Budesonide administered via Captisol-Enabled Budesonide nasal solution and Rhinocort Aqua in patients with seasonal allergic rhinitis (SAR) exposed to controlled ragweed pollen using an EEC model. 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
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
65 participants
Where
1 siteCanada
Study dates
Feb 2007to Apr 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 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, inclusive
  • Patients must have documentation of a positive skin test within 12 months of screening to 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 and must be using an acceptable birth control method
  • In generally good health
  • 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
  • Have clinically significant physical findings of nasal anatomical deformities causing greater than 50% obstruction
  • Previous participation in a budesonide study within three months prior to the Screening Visit.
  • Participation in any investigational drug trial within the 30 days preceding the Screening Visit, and thereafter.
  • A known hypersensitivity to any corticosteroid or any of the excipients in the formulation of the investigational drug
  • History of severe respiratory infection or disorder
Show all 25Show fewer
  • History of alcohol or drug abuse
  • History of a positive test for HIV, hepatitis B or hepatitis C.
  • Active asthma requiring treatment with inhaled or systemic corticosteroid and/or routine use of ß-agonists or any controller drugs, intermittent use (less than or equal to 3 uses per week) of inhaled short acting ß-agonists is acceptable.
  • Use of any of the prohibited medications within the identified exclusion periods
  • Use of antibiotic therapy for acute conditions within 14 days prior to the Screening Visit and thereafter. Low doses of antibiotics taken for prophylaxis are permitted based on the judgment of the Investigator if therapy was started prior to the Screening Visit AND is expected to continue throughout the study.
  • Initiation of immunotherapy or dose escalation during the study period. However, patients may be considered for inclusion if the immunotherapy was initiated 90 days or more prior to the Screening Visit AND if the dosing was stable (maintenance dose) for 30 days or more prior to the Screening Visit. No immunotherapy injections may be received within 48 hours prior to a ragweed pollen exposure visit.
  • Non-vaccinated exposure to or active infection with chickenpox or measles within the 21 days preceding the Screening Visit.
  • Exposure to systemic corticosteroids for any indication, chronic or intermittent (e.g., arthritis), during the 60 days preceding the Screening Visit, or presence of an underlying condition that can reasonably be expected to require treatment with corticosteroids during the course of the study.
  • Use of topical corticosteroids in concentrations in excess of 1% hydrocortisone or equivalent for dermatological conditions within 30 days prior to the Screening Visit
  • 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

Other trials in Canada

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, 3-Way Cross-Over Study to Compare the Relative Efficacy of Budesonide Administered Via CE Budesonide Nasal Solution & Rhinocort Aqua in the Treatment of the Symptoms of AR in an EEC Model

The primary objective of this study was to compare the relative efficacy of Budesonide administered via Captisol-Enabled Budesonide nasal solution and Rhinocort Aqua in patients with seasonal allergic rhinitis (SAR) exposed to controlled ragweed pollen using an EEC model.

Read the detailed description

A Randomized, Double-Blind, Placebo-Controlled, Single-Center, Three-Way Cross-Over Study to Compare the Relative Efficacy of Budesonide administered via Captisol-Enabled® Budesonide Nasal Solution and Rhinocort Aqua® (32 µg/spray) in the Treatment of the Symptoms of Allergic Rhinitis in an Environmental Exposure Chamber (EEC).

Being tested
Budesonide, Placebo
Keywords
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.

  • BudesonideDrug

    Also called CDX947, Captisol

    nasal spray, one spray per nostril at time 0

  • PlaceboDrug

    Also called phosphate buffered saline solution

    nasal spray, one spray per nostril at time 0

  • BudesonideDrug

    Also called Rhinocort Aqua

    nasal spray, one spray per nostril at time 0

Study groups in NCT00938613
Study groupRoleWhat they receive
Captisol-Enabled BudesonideExperimental32 ug/spray
Receives: Drug: Budesonide
Rhinocort AquaActive comparator32 ug/spray
Receives: Drug: Budesonide
PlaceboPlacebo comparatorposphate buffered saline
Receives: Drug: Placebo

What is being measured

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

  1. Total Nasal Symptom Score

    Measured: 15 mins, 30 mins, 45 mins, 60 mins, 90 mins, 120 mins, and then every hour up to 10 hours post dose

Secondary outcomes (3)

  1. Onset of action of active treatments as compared to placebo

    Measured: 15 mins, 30 mins, 45 mins, 60 mins, 90 mins, 120 mins and then every hour up to 10 hours post dose

  2. Compare the tolerance as measured by subject questionnaire and adverse events of Captisol-Enabled Budesonide nasal solution, Rhinocort Aqua and Placebo

    Measured: 15 mins, 30 mins, 45 mins, 60 mins, 90 mins, 120 mins, and then every hour up to 10 hours post dose

  3. Compare the effect and of the three treatments on an EEC-Specific Quality of Life questionnaire

    Measured: -0.75, 2, 6 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.

  1. First posted14 Jul 2009 (estimated)
  2. Study startFeb 2007
  3. Primary completionApr 2007
  4. Study completionApr 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
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00938613
Sponsor's protocol ID
CDX947CT001
Other IDs
P2DS06001
Status last verified
Oct 2012
First submitted
13 Jul 2009
Last updated
4 Oct 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Budesonide 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 8 inclusion and 25 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?

Total Nasal Symptom Score (time frame: 15 mins, 30 mins, 45 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?

On the ClinicalTrials.gov record for NCT00938613.

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.

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