An Allergen BioCube (ABC) Study Evaluating the Onset of Action of Fluticasone Furoate Nasal Spray and Olopatadine Nasal Spray Compared to Placebo
This study has been withdrawn prior to enrollment.
Sponsor:
ORA, Inc.
Information provided by (Responsible Party):
ORA, Inc.
ClinicalTrials.gov Identifier:
NCT01076439
First received: February 24, 2010
Last updated: February 21, 2012
Last verified: February 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to evaluate the onset of action of fluticasone furoate nasal spray compared to olopatadine nasal spray and placebo nasal spray in reducing nasal allergic signs and symptoms following ragweed exposure in the Allergen BioCube (ABC) after single dose administration and six consecutive days of treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Allergic Rhinitis |
Drug: Fluticasone Furoate Nasal Spray Drug: Olopatadine Nasal Spray Drug: Saline Nasal Spray |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Pilot Study Evaluating the Onset of Action of Fluticasone Furoate Nasal Spray and Olopatadine Nasal Spray Compared to Placebo Nasal Spray in Reducing Nasal Allergic Symptoms Following Ragweed Exposure in the Allergen BioCube (ABC) |
Resource links provided by NLM:
Drug Information available for:
Fluticasone propionate
Fluticasone
Olopatadine
Olopatadine hydrochloride
Fluticasone furoate
U.S. FDA Resources
Further study details as provided by ORA, Inc.:
Primary Outcome Measures:
- Nasal Signs and Symptoms (TNSS) [ Time Frame: Evaluated by the subject pre-ABC exposure, every 15 minutes during all ragweed exposures in the ABC, and post-ABC exposure ] [ Designated as safety issue: No ]TNSS (0-12 unit scale) is defined as the sum of the four nasal symptom scores recorded for nasal itching, sneezing, rhinorrhea and nasal congestion.
Secondary Outcome Measures:
- Peak Expiratory Flow Rate (PEFR) [ Time Frame: Measured pre-ABC exposure, every 30 minutes during all ragweed exposures in the ABC, and post-ABC exposure ] [ Designated as safety issue: Yes ]
- Peak Nasal Inspiratory Flow (PNIF) [ Time Frame: Measured pre-ABC exposure, every 30 minutes during all ragweed exposures in the ABC, and post-ABC exposure ] [ Designated as safety issue: No ]
- Headaches [ Time Frame: Evaluated by the subject pre-ABC exposure, every 30 minutes during all ragweed exposures in the ABC, and post-ABC exposure ] [ Designated as safety issue: No ]
| Enrollment: | 0 |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Olopatadine Nasal Spray (Patanase) |
Drug: Olopatadine Nasal Spray
Olopatadine Nasal Spray: 2660mcg BID
|
| Active Comparator: Fluticasone Furoate Nasal Spray (Veramyst) |
Drug: Fluticasone Furoate Nasal Spray
Fluticasone Furoate Nasal Spray: 110mcg QD
|
| Placebo Comparator: Saline Nasal Spray (Placebo) |
Drug: Saline Nasal Spray
Placebo
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- provide written informed consent and signed HIPAA form;
- be able and willing to follow all instructions and attend the study visits;
- if female and of childbearing potential, be not pregnant, nursing or planning a pregnancy, be willing to submit a pregnancy test at visit 1 and at exit visit, and to use adequate method of birth control
- have a positive history of seasonal allergic rhinitis to ragweed;
- have a positive skin test reaction to ragweed of within the past 24 months;
- manifest sufficient allergic rhinitis symptoms during ragweed exposure in the ABC
Exclusion Criteria:
- manifest symptoms of clinically active allergic rhinitis at the start of Visit 1 or Visit 2;
- known intolerance or allergy to antihistamines or corticosteroids;
- have a compromised lung function at Visit 1;
- have significant nasal anatomical deformities or any condition that does not allow subject to breathe through the nose (includes, but is not limited to: septal deviation, septal perforations, nasal polyps, rhinitis medicamentosa)
- have had any nasal surgical intervention in the past;
- have planned surgery (nasal, ocular or systemic) during the trial period or within 30 days thereafter;
- use disallowed medications (topical, topical ophthalmic, systemic and/or injectable treatments and all anti-allergy therapies including prescription, over the counter or homeopathy, and over the counter sleeping aids) during the study or appropriate pre-study washout period
Contacts and Locations More Information
No publications provided
| Responsible Party: | ORA, Inc. |
| ClinicalTrials.gov Identifier: | NCT01076439 History of Changes |
| Other Study ID Numbers: | 10-270-0006 |
| Study First Received: | February 24, 2010 |
| Last Updated: | February 21, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Rhinitis Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases Fluticasone Olopatadine Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses |
Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Antirheumatic Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 13, 2013