The Effect of Nasal Carbon Dioxide (CO2) in the Symptomatic Treatment of Seasonal Allergic Rhinitis

Completed · Phase 2 · Has a placebo group

Conditions studied: Seasonal Allergic Rhinitis

In brief

The purpose of this study is to evaluate the effect of four times a day treatment with nasal carbon dioxide in patients with Seasonal Allergic Rhinitis symptoms.

Key facts

Study ID

NCT00917111

Run by

Capnia, Inc.

People needed

33

Starts

2009-07-01

Expected to finish

2009-11-01

Last updated by the study team

2012-08-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must meet all of the following inclusion criteria to be considered eligible for study enrollment:
• Able to read and understand informed consent form and voluntarily consent to participate in this study by signing the IRB/EC-approved informed consent form
• Males or females ages 18 - 65 years
• Able to comply with the requirements of the protocol
• Minimal 2-year history of seasonal allergic rhinitis requiring pharmacotherapy
• Positive skin test to one or more seasonal allergens prevalent in the respective local geographical area by either prick or intradermal methods within 12 months prior to enrollment
• Females of childbearing potential must commit to using an acceptable method of birth control (e.g., oral birth control pills, intrauterine device (IUD), or a double-barrier method of contraception) through 7 days after last study drug administration. To be considered not of childbearing potential, females must be post-menopausal for at least 2 years or be surgically sterile

You may not qualify if…

• Patients must not meet any of the following exclusion criteria to be considered eligible for study enrollment:
• History of asthma (other than mild intermittent)
• Nasal disorders that are assessed as clinically significant
• Acute or significant sinusitis or upper respiratory infection within 14 days of enrollment
• Existing serious medical condition that precludes participation
• Females who are pregnant or breast-feeding and/or plan to become pregnant or to breast-feed during study participating or within 7 days after last study drug administration
• Initiation of immunotherapy or have a change in immunotherapy dose within the 6 months preceding enrollment (if on immunotherapy, the same dose must be maintained throughout the trial)
• Use of medications and/or treatments (e.g., tricyclic antidepressants) that could affect the assessment of the effectiveness of the study drug
• Use of concomitant medications or other treatments for trigeminally-mediated diseases (i.e., migraine, TMD, trigeminal neuralgia, etc.) for the duration of the Treatment Period of this study
• An employee of the study site's research department
• Have a member of the same household also participating in this study
• Use of any investigational or experimental therapy within 30 days of enrollment
• Planned travel outside the study area for the duration of study period
• Participation in a previous study with nasal CO2
• Prior to enrollment and the initiation of the run-in period, patients must meet the following criteria:
• Continue to meet all inclusion criteria
• Do not meet any of the exclusion criteria
• Complete the required washout period of the following medications:
• Nasal or systemic decongestants (3 days)
• Nasal, ophthalmic, or systemic short-acting antihistamines (7 days)
• Nasal or systemic long-acting antihistamines such as cetirizine and fexofenadine (7 days)
• Leukotriene modifiers such as montelukast, zafirlukast and ziluton (7 days)
• Any other nasal medications including homeopathy, natural products, etc. (7 days)
• Loratadine (10 days)
• Nasal cromolyn (14 days)

Where it is running

• Capnia Investigative Site — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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