Back to results

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

Primary Purpose

Seasonal Allergic Rhinitis

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Nasal CO2

Placebo

About this trial

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

Eligibility Criteria

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

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

CO2 Gas

Inactive Placebo Gas

Outcomes

Primary Outcome Measures

The mean change in reflective Total Nasal Symptom Score (TNSS) over the Treatment Period compared to baseline in nasal CO2 or placebo

Secondary Outcome Measures

Full Information

NCT ID

NCT00688441

First Posted

May 29, 2008

Last Updated

August 18, 2010

Sponsor

Capnia, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00688441

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

August 2010

Overall Recruitment Status

Completed

Study Start Date

July 2008 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Capnia, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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

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.

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, Placebo-Controlled, Phase II, Nasal Carbon Dioxide, Carbon Dioxide, Efficacy, Safety, Total Nasal Symptom Score, RQLQ

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

453 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active

Arm Type

Experimental

Arm Description

CO2 Gas

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Inactive Placebo Gas

Intervention Type

Drug

Intervention Name(s)

Nasal CO2

Intervention Description

Twice daily during the 14 day Treatment Period

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Use of the study drug dispenser at the same frequency as the active arm

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

S. David Miller, MD

Organizational Affiliation

Northeast Medical Research Associates, Inc.

Official's Role

Study Chair

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs