Seasonal Allergic RhinitisPhase 2NCT00917020
The Effect of Nasal Carbon Dioxide (CO2) Used As-Needed in the Symptomatic Treatment of Seasonal Allergic Rhinitis
A Phase 2 study testing Nasal CO2 in people with Seasonal Allergic Rhinitis, run by Capnia, Inc. at 1 site in United States.
Trial 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. 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
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Nov 2009
- 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
- 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
Who cannot join
- 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
Show all 33Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Nasal CO2, Inactive Placebo Gas
- Keywords
- Randomized, Double-Blind, Multi-Center, Phase II, Nasal Carbon Dioxide, Carbon Dioxide, Efficacy, Safety, Total Nasal Symptom Score
- 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
As-Needed during the 14 day Treatment Period
Inactive Placebo GasDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Active: CO2 Gas | Experimental | Not described Receives: Drug: Nasal CO2 |
| Inactive Placebo Gas | Placebo comparator | Not described Receives: Drug: Inactive Placebo Gas |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the efficacy of as-needed treatment with nasal carbon dioxide (CO2) in patients with seasonal allergic rhinitis (SAR).
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 posted10 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionOct 2009
- Study completionNov 2009
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capnia, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anish Bhatnagar, MD, Study director, Capnia, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917020
- Sponsor's protocol ID
- C216
- Status last verified
- Aug 2012
- First submitted
- 8 Jun 2009
- Last updated
- 15 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00917020
- Acronym / sponsor ID
- C216
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- Randomized, Double-Blind, Multi-Center, Phase II, Nasal Carbon Dioxide, Carbon Dioxide, Efficacy, Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Capnia, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 10 Jun 2009 (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 effect of as-needed treatment with nasal carbon dioxide in patients with Seasonal Allergic Rhinitis symptoms.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active: CO2 Gas | Experimental | Drug: Nasal CO2 |
| Inactive Placebo Gas | Placebo comparator | Drug: Inactive Placebo Gas |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must meet all of the following inclusion criteria to be considered eligible for study enrollment:
Key exclusion criteria (33 listed)
- Patients must not meet any of the following exclusion criteria to be considered eligible for study enrollment:
- 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:
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 CO2As-Needed during the 14 day Treatment Period | Drug | Active: CO2 Gas |
| Inactive Placebo GasPlacebo | Drug | Inactive Placebo Gas |
Primary outcome
To assess the efficacy of as-needed treatment with nasal carbon dioxide (CO2) in patients with seasonal allergic rhinitis (SAR).
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 15 Aug 2012.
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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.
Anish Bhatnagar, MD study director
Capnia, Inc.
1 site in 1 country: see every site and its status.
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. at 1 site in United States.
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 7 inclusion and 33 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 15 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
To assess the efficacy of as-needed treatment with nasal carbon dioxide (CO2) in patients with seasonal allergic rhinitis (SAR). (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 15 Aug 2012.