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

Information source: Ligand Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Seasonal Allergic Rhinitis

Intervention: Budesonide (Drug); Placebo (Drug); Budesonide (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Ligand Pharmaceuticals

Official(s) and/or principal investigator(s):
Deepen Patel, MD, Principal Investigator, Affiliation: Allied Research International - Cetero Research

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Total Nasal Symptom Score

Secondary outcome:

Onset of action of active treatments as compared to placebo

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

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

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).

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 Exclusion Criteria:

- 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

- 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

Locations and Contacts

Allied Research International - Cetero Research, Mississauga, Ontario L4W 1N2, Canada
Additional Information

Starting date: February 2007
Last updated: October 2, 2012

Page last updated: August 23, 2015

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