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

Seasonal Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00688441
• Other study ID #: C215
• Status: Completed
• Phase: Phase 2
• First received: May 29, 2008
• Last updated: August 18, 2010
• Start date: July 2008
• Est. completion date: November 2008

Study information

• Verified date: August 2010
• Source: Capnia, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 453
• Est. completion date: November 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• Nasal CO2
Twice daily during the 14 day Treatment Period
• Placebo
Use of the study drug dispenser at the same frequency as the active arm

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Capnia, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean change in reflective Total Nasal Symptom Score (TNSS) over the Treatment Period compared to baseline in nasal CO2 or placebo		14 days	No