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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00688441
Recruitment Status : Completed
First Posted : June 3, 2008
Last Update Posted : August 20, 2010
Information provided by:
Capnia, Inc.

Brief Summary:
The purpose of this study is to evaluate the safety and effect of nasal carbon dioxide in the treatment of Seasonal Allergic Rhinitis

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Drug: Nasal CO2 Drug: Placebo Phase 2

Detailed Description:
This multi-center, randomized, double-blind, placebo-controlled, parallel group trial will evaluate the efficacy and safety of a nasal, non-inhaled administration of carbon dioxide (CO2) in patients with seasonal allergic rhinitis. An estimated 500 patients who meet the eligibility criteria will be enrolled into this study at approximately 25 sites to ensure that approximately 400 patients are randomized and complete the study.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever

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

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00688441

Sponsors and Collaborators
Capnia, Inc.
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Study Chair: S. David Miller, MD Northeast Medical Research Associates, Inc.

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Responsible Party: Kristen Yen, Associate Director, Clinical, Capnia, Inc. 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.:
Nasal Carbon Dioxide
Carbon Dioxide
Phase II
Total Nasal Symptom Score
Additional relevant MeSH terms:
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Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases