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

NCT00917020 | Completed Phase 2

• 1 other identifier: C216
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Seasonal Allergic Rhinitis

Keywords

Randomized; Double-Blind; Multi-Center; Phase II; Nasal Carbon Dioxide; Carbon Dioxide; Efficacy; Safety; Total Nasal Symptom Score

Outcome Measures

Primary Outcomes (1)

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

  14 Days

Study Arms (2)

Active: CO2 Gas

EXPERIMENTAL

Drug: Nasal CO2

Inactive Placebo Gas

PLACEBO COMPARATOR

Drug: Inactive Placebo Gas

Interventions

Nasal CO2 DRUG

As-Needed during the 14 day Treatment Period

Active: CO2 Gas

Inactive Placebo Gas DRUG

Placebo

Inactive Placebo Gas

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Complete the required washout period of the following medications:

Sponsors & Collaborators

• Capnia, Inc.: lead

Study Sites (1)

Capnia Investigative Site

St Louis, Missouri, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Anish Bhatnagar, MD

  Capnia, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2009
• First Posted: June 10, 2009
• Study Start: July 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: November 1, 2009
• Last Updated: August 15, 2012

Record last verified: 2012-08

Locations

US (1)