Seasonal Allergic RhinitisPhase 2NCT00688441
The Effect of Nasal Carbon Dioxide (CO2) in the Treatment of Seasonal Allergic Rhinitis
A Phase 2 study testing Nasal CO2 in people with Seasonal Allergic Rhinitis, run by Capnia, Inc..
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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Nasal CO2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 453 participants
- Where
- No sites listed yet
- Study dates
- Jul 2008to Nov 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
The purpose of this study is to evaluate the safety and effect of nasal carbon dioxide in the treatment of Seasonal Allergic Rhinitis
Read the 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.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Nasal CO2, Placebo
- Keywords
- Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Phase II, Nasal Carbon Dioxide, Carbon Dioxide, Efficacy, Safety, Total Nasal Symptom Score, RQLQ
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal CO2Drug
Twice daily during the 14 day Treatment Period
PlaceboDrug
Use of the study drug dispenser at the same frequency as the active arm
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | CO2 Gas Receives: Drug: Nasal CO2 |
| Placebo | Placebo comparator | Inactive Placebo Gas Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean change in reflective Total Nasal Symptom Score (TNSS) over the Treatment Period compared to baseline in nasal CO2 or placebo
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startJul 2008
- Primary completionOct 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 453 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capnia, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- S. David Miller, MD, Study chair, Northeast Medical Research Associates, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00688441
- Sponsor's protocol ID
- C215
- Status last verified
- Aug 2010
- First submitted
- 29 May 2008
- Last updated
- 20 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00688441
- Acronym / sponsor ID
- C215
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Phase II, Nasal Carbon Dioxide, Carbon Dioxide, Efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 453 participants (actual)
- Lead sponsor
- Capnia, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 3 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and effect of nasal carbon dioxide in the treatment of Seasonal Allergic Rhinitis
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: Nasal CO2CO2 Gas |
| Placebo | Placebo comparator | Drug: PlaceboInactive Placebo Gas |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal CO2Twice daily during the 14 day Treatment Period | Drug | Active |
| PlaceboUse of the study drug dispenser at the same frequency as the active arm | Drug | Placebo |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
S. David Miller, MD study chair
Northeast Medical Research Associates, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nasal CO2 in people with Seasonal Allergic Rhinitis, run by Capnia, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2010; AzTrials last refreshed its copy on 8 Nov 2026.