The Effect of Nasal Carbon Dioxide (CO2) in the Treatment of Seasonal Allergic Rhinitis
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ClinicalTrials.gov Identifier: NCT00688441 |
Recruitment Status
:
Completed
First Posted
: June 3, 2008
Last Update Posted
: August 20, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Seasonal Allergic Rhinitis | Drug: Nasal CO2 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 453 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Nasal Carbon Dioxide in the Treatment of Seasonal Allergic Rhinitis |
Study Start Date : | July 2008 |
Actual Primary Completion Date : | October 2008 |
Actual Study Completion Date : | November 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: Active
CO2 Gas
|
Drug: Nasal CO2
Twice daily during the 14 day Treatment Period
|
Placebo Comparator: Placebo
Inactive Placebo Gas
|
Drug: Placebo
Use of the study drug dispenser at the same frequency as the active arm
|
- The mean change in reflective Total Nasal Symptom Score (TNSS) over the Treatment Period compared to baseline in nasal CO2 or placebo [ Time Frame: 14 days ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Able to read and understand informed consent and voluntarily consent to sign the informed consent form
- Able to comply with the requirements of the protocol (e.g., complete the diary within the protocol-specified window)
- Minimal 2-year history of Fall seasonal allergic rhinitis requiring pharmacotherapy
- Positive skin test to one or more Fall seasonal allergen (e.g., ragweed, birch pollen, etc.)
- Females of childbearing potential must commit to using an acceptable method of birth control and have a negative pregnancy test
Exclusion Criteria:
- History of asthma (other than mild intermittent)
- Acute or significant sinusitis or upper respiratory infection within 14 days of enrollment
- Existing serious medical condition (e.g., severe emphysema) that precludes participation
- Females who are pregnant or breast-feeding and/or who plan to become pregnant or to breast-feed during the study participation or within 7 days after the 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)
- Planned travel outside the study area for the duration of study period
- Participation in another clinical study within 30 days of planned enrollment date and for the duration of the study
- Participation in a previous study with Nasal CO2

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00688441
Study Chair: | S. David Miller, MD | Northeast Medical Research Associates, Inc. |
Responsible Party: | Kristen Yen, Associate Director, Clinical, Capnia, Inc. |
ClinicalTrials.gov Identifier: | NCT00688441 History of Changes |
Other Study ID Numbers: |
C215 |
First Posted: | June 3, 2008 Key Record Dates |
Last Update Posted: | August 20, 2010 |
Last Verified: | August 2010 |
Keywords provided by Capnia, Inc.:
Randomized Double-Blind Multi-Center Placebo-Controlled Phase II Nasal Carbon Dioxide |
Carbon Dioxide Efficacy Safety Total Nasal Symptom Score RQLQ |
Additional relevant MeSH terms:
Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Otorhinolaryngologic Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |