Perennial Allergic RhinitisPhase 2NCT00638755
The Effect of Nasal Carbon Dioxide (CO2) on Nasal Congestion in Subjects With Perennial Allergic Rhinitis
A Phase 2 study testing Nasal Carbon Dioxide in people with Perennial 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 nasal CO2 on nasal congestion and other symptoms related to Perennial Allergic Rhinitis. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Perennial Allergic Rhinitis
- What is being tested?
- Nasal Carbon Dioxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jul 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a history consistent with minimal 2 year history of perennial allergic rhinitis requiring pharmacotherapy.
- Positive skin test to perennial allergens (e.g. cats, dogs, house dust mite, 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 or intermittent)
- Clinically significant nasal disorders
- Acute or significant sinusitis or upper respiratory infection within 14 days of randomization
- Have an existing serious medical condition (such as severe emphysema, other respiratory diseases, heart disease, etc.) that precludes participation in the study
- Use of certain medication s prior to randomization and during study participation
- Participation in prior study with Nasal CO2
- Participation in another clinical study within 30 days of planned randomization date and for the duration of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Study to Evaluate the Effect of Nasal Carbon Dioxide on Nasal Congestion Via Acoustic Rhinometry in Subjects With Perennial Allergic Rhinitis
The purpose of this study is to evaluate the effect of nasal CO2 on nasal congestion and other symptoms related to Perennial Allergic Rhinitis.
Read the detailed description
A randomized study to evaluated the safety and effect of nasal carbon dioxide on nasal congestion using acoustic rhinometry in subjects with perennial allergic rhinitis. The acoustic rhinometry is an instrument that will be used to assess the levels of the nasal congestion in each subject. Approximately 20 men and women ages 19-65 years old who have a history consistent with perennial allergic rhinitis requiring pharmacology for at least 2 years and meet all other eligibility criteria will be enrolled in this study. There will be six (6) visits to the clinic. There will be a screening visit, four (4) treatment visits, and an end of study visit. A subject's participation in the study may last up to 58 days. There will be four different doses given in this study. Each subject will receive 3 different doses of the study drug and one dose of the placebo.
- Conditions
- Perennial Allergic Rhinitis
- Being tested
- Nasal Carbon Dioxide
- Keywords
- Allergic Rhinitis, Perennial Allergic Rhinitis, Allergies to perennial allergens, Allergies to perennial allergens (e.g. dog, cat, dust mites, etc.)
- Medical subject headings
- Rhinitis, Allergic, Perennial, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal Carbon DioxideDrug
Nasal Carbon Dioxide
Nasal Carbon DioxideDrug
Nasal Carbon Dioxide
Nasal Carbon DioxideDrug
Nasal Carbon Dioxide
Nasal Carbon DioxideDrug
Nasal Carbon Dioxide
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | The following treatment sequence: A (Nasal Carbon Dioxide), B (Nasal Carbon Dioxide), C (Nasal Carbon Dioxide), D (placebo) Receives: Drug: Nasal Carbon Dioxide |
| 2 | Experimental | The following treatment sequence: B (Nasal Carbon Dioxide), C (Nasal Carbon Dioxide), D (placebo), A (Nasal Carbon Dioxide) Receives: Drug: Nasal Carbon Dioxide |
| 3 | Experimental | The following treatment sequence: C (Nasal Carbon Dioxide), D (placebo), A (Nasal Carbon Dioxide), B (Nasal Carbon Dioxide) Receives: Drug: Nasal Carbon Dioxide |
| 4 | Experimental | The following treatment sequence: D (placebo), A (Nasal Carbon Dioxide), B (Nasal Carbon Dioxide), C (Nasal Carbon Dioxide) Receives: Drug: Nasal Carbon Dioxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the dose-related effects of CO2 on nasal congestion assessed by acoustic rhinometry.
Measured: Baseline, Post Treatment: 15 mins, 30 mins, 45 mins, 1 hour, 2 hours, 3 hours, 4 hours
Secondary outcomes (2)
Change from baseline in olfactory test scores post-treatment
Measured: Baseline, Post Treatment: 1 hour & 3 hours
TNSS, TNNSS, and TSS comparisons at multiple timepoints
Measured: Baseline, Post Treatment: 15 mins, 30 mins, 45 mins, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 12 hours, 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionMay 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perennial 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capnia, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Capnia Clinical Study Investigator, Principal investigator, Capnia Investigative Site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00638755
- Sponsor's protocol ID
- C213
- Status last verified
- Aug 2010
- First submitted
- 13 Mar 2008
- Last updated
- 19 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Study to Evaluate the Effect of Nasal Carbon Dioxide on Nasal Congestion Via Acoustic Rhinometry in Subjects With Perennial Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT00638755
- Acronym / sponsor ID
- C213
- Conditions
- Perennial Allergic Rhinitis
- Keywords
- Allergic Rhinitis, Perennial Allergic Rhinitis, Allergies to perennial allergens, Allergies to perennial allergens (e.g. dog, cat, dust mites, etc.)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Capnia, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- May 2008 (actual)
- Study completion
- Jul 2008
- First posted
- 19 Mar 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 effect of nasal CO2 on nasal congestion and other symptoms related to Perennial Allergic Rhinitis.
Detailed description
A randomized study to evaluated the safety and effect of nasal carbon dioxide on nasal congestion using acoustic rhinometry in subjects with perennial allergic rhinitis. The acoustic rhinometry is an instrument that will be used to assess the levels of the nasal congestion in each subject. Approximately 20 men and women ages 19-65 years old who have a history consistent with perennial allergic rhinitis requiring pharmacology for at least 2 years and meet all other eligibility criteria will be enrolled in this study. There will be six (6) visits to the clinic. There will be a screening visit, four (4) treatment visits, and an end of study visit. A subject's participation in the study may last up to 58 days. There will be four different doses given in this study. Each subject will receive 3 different doses of the study drug and one dose of the placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Nasal Carbon DioxideThe following treatment sequence: A (Nasal Carbon Dioxide), B (Nasal Carbon Dioxide), C (Nasal Carbon Dioxide), D (placebo) |
| 2 | Experimental | Drug: Nasal Carbon DioxideThe following treatment sequence: B (Nasal Carbon Dioxide), C (Nasal Carbon Dioxide), D (placebo), A (Nasal Carbon Dioxide) |
| 3 | Experimental | Drug: Nasal Carbon DioxideThe following treatment sequence: C (Nasal Carbon Dioxide), D (placebo), A (Nasal Carbon Dioxide), B (Nasal Carbon Dioxide) |
| 4 | Experimental | Drug: Nasal Carbon DioxideThe following treatment sequence: D (placebo), A (Nasal Carbon Dioxide), B (Nasal Carbon Dioxide), C (Nasal Carbon Dioxide) |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have a history consistent with minimal 2 year history of perennial allergic rhinitis requiring pharmacotherapy.
- Positive skin test to perennial allergens (e.g. cats, dogs, house dust mite, etc.)
- Females of childbearing potential must commit to using an acceptable method of birth control and have a negative pregnancy test
Key exclusion criteria (7 listed)
- History of asthma (other than mild or intermittent)
- Clinically significant nasal disorders
- Acute or significant sinusitis or upper respiratory infection within 14 days of randomization
- Have an existing serious medical condition (such as severe emphysema, other respiratory diseases, heart disease, etc.) that precludes participation in the study
- Use of certain medication s prior to randomization and during study participation
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 Carbon DioxideNasal Carbon Dioxide | Drug | 1 |
| Nasal Carbon DioxideNasal Carbon Dioxide | Drug | 2 |
| Nasal Carbon DioxideNasal Carbon Dioxide | Drug | 3 |
| Nasal Carbon DioxideNasal Carbon Dioxide | Drug | 4 |
Primary outcome
Determine the dose-related effects of CO2 on nasal congestion assessed by acoustic rhinometry.
Time frame: Baseline, Post Treatment: 15 mins, 30 mins, 45 mins, 1 hour, 2 hours, 3 hours, 4 hours
2 secondary outcomes
Change from baseline in olfactory test scores post-treatment
Time frame: Baseline, Post Treatment: 1 hour & 3 hours
TNSS, TNNSS, and TSS comparisons at multiple timepoints
Time frame: Baseline, Post Treatment: 15 mins, 30 mins, 45 mins, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 12 hours, 24 hours
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 19 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.
Capnia Clinical Study Investigator principal investigator
Capnia Investigative Site
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 Carbon Dioxide in people with Perennial 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 3 inclusion and 7 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 19 Aug 2010. 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. 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?
Determine the dose-related effects of CO2 on nasal congestion assessed by acoustic rhinometry. (time frame: Baseline, Post Treatment: 15 mins, 30 mins, 45 mins, 1 hour, 2 hours, 3 hours, 4 hours). 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 19 Aug 2010.