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

This study has been completed.
Sponsor:
Information provided by:
Capnia, Inc.
ClinicalTrials.gov Identifier:
NCT00688441
First received: May 29, 2008
Last updated: August 18, 2010
Last verified: August 2010
  Purpose

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


Condition Intervention Phase
Seasonal Allergic Rhinitis
Drug: Nasal CO2
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Capnia, Inc.:

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 [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 453
Study Start Date: July 2008
Study Completion Date: November 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00688441

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

No publications provided

Responsible Party: Kristen Yen, Associate Director, Clinical, Capnia, Inc.
ClinicalTrials.gov Identifier: NCT00688441     History of Changes
Other Study ID Numbers: C215
Study First Received: May 29, 2008
Last Updated: August 18, 2010
Health Authority: United States: Food and Drug Administration

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, Perennial
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 30, 2014