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

Primary Purpose

Seasonal Allergic Rhinitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nasal CO2
Inactive Placebo Gas
Sponsored by
Capnia, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis focused on measuring Randomized, Double-Blind, Multi-Center, Phase II, Nasal Carbon Dioxide, Carbon Dioxide, Efficacy, Safety, Total Nasal Symptom Score

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
    • Nasal, inhaled, ophthalmic, or systemic corticosteroids (30 days)
    • Tricyclic antidepressants or any other medication that could affect assessment of the effectiveness of study drug (7 days)

Prior to randomization, patients must meet the following criteria:

  • Continue to meet all inclusion criteria
  • Do not meet any of the exclusion criteria
  • Did not take any medications requiring washout and must agree to refrain from taking any pharmacotherapy or any other treatments for seasonal allergic rhinitis such as homeopathy, natural health products, etc., for their SAR symptoms during the 14-day Treatment Period.
  • Complete at least a minimum of symptom score diary entries at the specified timepoints during the baseline symptom assessment period
  • Have a minimum total nasal symptom score (TNSS) as defined by the protocol

Sites / Locations

  • Capnia Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active: CO2 Gas

Inactive Placebo Gas

Arm Description

Outcomes

Primary Outcome Measures

To assess the efficacy of as-needed treatment with nasal carbon dioxide (CO2) in patients with seasonal allergic rhinitis (SAR).

Secondary Outcome Measures

Full Information

First Posted
June 8, 2009
Last Updated
August 6, 2012
Sponsor
Capnia, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00917020
Brief Title
The Effect of Nasal Carbon Dioxide (CO2) Used As-Needed in the Symptomatic Treatment of Seasonal Allergic Rhinitis
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Pilot Study to Evaluate the Efficacy and Safety of Nasal Carbon Dioxide Used As-Needed in the Symptomatic Treatment of Seasonal Allergic Rhinitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Capnia, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effect of as-needed treatment with nasal carbon dioxide in patients with Seasonal Allergic Rhinitis symptoms.
Detailed Description
This randomized, double-blind, placebo-controlled, multi-center, parallel group, pilot study will evaluate the efficacy and safety of as-needed with nasal, non-inhaled administration of CO2 (nasal CO2) in patients with SAR. Approximately 50 patients who meet the eligibility criteria will be enrolled into this study at up to 4 sites to ensure that approximately 30 patients complete the study. Patients will be randomized to one of two treatment groups and be provided with either an active or placebo dispenser. All patients will administer study drug for 10 seconds to each nostril once on Day 0 in the clinic then as-needed up to 6 times a day during waking hours (doses must be at least 2 hours apart) for 14 days. Patients will assess their nasal and non-nasal symptoms in a patient diary. Each patient's participation in the study may last up to 72 days. There will be a total of 5 scheduled clinic visits: Visit 1 Screening Visit 2 Enrollment (within 42 days of Visit 1) Visit 3 Randomization (after the completion of a 3-7 day run-in period) Visit 4 Mid-Treatment (Day 7 ± 1 day) Visit 5 End of Treatment (within 1-3 days of last study drug administration) Sites will follow-up with randomized patients via telephone 7 ± 1 days after the last study drug administration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis
Keywords
Randomized, Double-Blind, Multi-Center, Phase II, Nasal Carbon Dioxide, Carbon Dioxide, Efficacy, Safety, Total Nasal Symptom Score

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active: CO2 Gas
Arm Type
Experimental
Arm Title
Inactive Placebo Gas
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Nasal CO2
Intervention Description
As-Needed during the 14 day Treatment Period
Intervention Type
Drug
Intervention Name(s)
Inactive Placebo Gas
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
To assess the efficacy of as-needed treatment with nasal carbon dioxide (CO2) in patients with seasonal allergic rhinitis (SAR).
Time Frame
14 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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) Nasal, inhaled, ophthalmic, or systemic corticosteroids (30 days) Tricyclic antidepressants or any other medication that could affect assessment of the effectiveness of study drug (7 days) Prior to randomization, patients must meet the following criteria: Continue to meet all inclusion criteria Do not meet any of the exclusion criteria Did not take any medications requiring washout and must agree to refrain from taking any pharmacotherapy or any other treatments for seasonal allergic rhinitis such as homeopathy, natural health products, etc., for their SAR symptoms during the 14-day Treatment Period. Complete at least a minimum of symptom score diary entries at the specified timepoints during the baseline symptom assessment period Have a minimum total nasal symptom score (TNSS) as defined by the protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anish Bhatnagar, MD
Organizational Affiliation
Capnia, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Capnia Investigative Site
City
St. Louis
State/Province
Missouri
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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