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

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

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.

Study Overview

• Status: Completed
• Conditions: Seasonal Allergic Rhinitis
• Intervention / Treatment: Drug: Nasal CO2; Drug: Inactive Placebo Gas

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St. Louis, Missouri, United States
      • Capnia Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active: CO2 Gas	Drug: Nasal CO2; As-Needed during the 14 day Treatment Period
Placebo Comparator: Inactive Placebo Gas	Drug: Inactive Placebo Gas; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess the efficacy of as-needed treatment with nasal carbon dioxide (CO2) in patients with seasonal allergic rhinitis (SAR).	14 Days

Collaborators and Investigators

• Sponsor: Capnia, Inc.
• Investigators: Study Director: Anish Bhatnagar, MD, Capnia, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: June 8, 2009
• First Submitted That Met QC Criteria: June 9, 2009
• First Posted (Estimate): June 10, 2009

Study Record Updates

• Last Update Posted (Estimate): August 15, 2012
• Last Update Submitted That Met QC Criteria: August 6, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Double-Blind; Randomized; Phase II; Multi-Center; Nasal Carbon Dioxide; Carbon Dioxide; Total Nasal Symptom Score
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
• Other Study ID Numbers: C216