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

NCT00688441 | Completed Phase 2

• 1 other identifier: C215
• Study Type: interventional
• Target: 453
• Locations: 0 countries
• Sites: N/A

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  14 days

Study Arms (2)

Active

EXPERIMENTAL

CO2 Gas

Drug: Nasal CO2

Placebo

PLACEBO COMPARATOR

Inactive Placebo Gas

Drug: Placebo

Interventions

Nasal CO2 DRUG

Twice daily during the 14 day Treatment Period

Active

Placebo DRUG

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

Placebo

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Capnia, Inc.: lead

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

• S. David Miller, MD

  Northeast Medical Research Associates, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 29, 2008
• First Posted: June 3, 2008
• Study Start: July 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: November 1, 2008
• Last Updated: August 20, 2010

Record last verified: 2010-08