Vasomotor RhinitisNCT00415493
Nasal Physiologic Reactivity of Nonallergic Rhinitics to Cold Air Provocation
A study testing Cold-dry air provocation and Warm-moist air provocation in people with Vasomotor Rhinitis, run by Associated Scientists to Help Minimize Allergies at 1 site in United States.
Trial summary
This study seeks to compare patients with vasomotor rhinitis ("perennial nonallergic rhinitis," "idiopathic rhinitis") with normal controls with respect to their nasal physiologic reactivity to cold air challenge. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Vasomotor Rhinitis
- What is being tested?
- Cold-dry air provocation and Warm-moist air provocation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to May 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- (cases; n = 14 total; 10 with predominantly "physical" and 4 with predominantly "irritant"triggers):
- A significant history of chronic and/or recurrent nasal symptoms (rhinorrhea, blockage,sneezing or pruritus) in response to:
- Changes in temperature and/or humidity predominantly ("physical triggers"; n = 10); or
- Two or more nonspecific irritant triggers predominantly, including: perfumes or colognes,cleaning products, environmental tobacco smoke, vehicular exhaust, paint odors, etc. ("irritant triggers";n = 4). This history shall be of at least two years' duration.
Who cannot join
- (controls; n = 10):
- A significant history of chronic and/or recurrent nasal symptoms (rhinorrhea, blockage,sneezing or pruritus) in response to one or more nonallergic triggers, including: perfumes or colognes, cleaning products, environmental tobacco smoke, vehicular exhaust, paint odors, changes in temperature and/or humidity.
- (all subjects; n = 24):
- A prior history of allergic disease (allergic rhinitis, asthma, angioedema, anaphylaxis)
- Significant skin test reactivity to one or more substances in a panel of 24 locally relevant seasonal and perennial aeroallergens
- Negative wheal response to positive control (histamine) on skin test panel
Show all 14Show fewer
- Abnormalities on a screening x-ray (Waters view) of the paranasal sinuses
- Cigarette smoking (active, within previous 6 months or cumulative history of >20 pack years)
- Chronic cardiopulmonary diseases (asthma, COPD, coronary artery disease…)
- Continuous therapy with medications having antihistaminic or autonomic primary or secondary effects (e.g., oral or topical antihistamines, tricyclic antidepressants, ipratropium bromide, albuterol, alpha- or beta-adrenergic blockers...)
- Unable to provide meaningful tracings on screening rhinomanometry.
- Pregnancy (or planned pregnancy within 6 months); positive urinary HCG at screening visit. Patient is a breast feeding female.
- Upper respiratory infection (common cold or sinusitis) within 2 week of screening.
- Patient has participated in a clinical trial involving an investigational drug within 4 weeks of visit 1.
Trial locations and contacts
1 site in 1 country.
About this study
This study seeks to compare patients with vasomotor rhinitis ("perennial nonallergic rhinitis," "idiopathic rhinitis") with normal controls with respect to their nasal physiologic reactivity to cold air challenge. Ten vasomotor rhinitis (VMR) patients with nasal symptoms triggered predominantly by cold air, four VMR patients with symptoms triggered predominantly by chemicals, and ten nonallergic, non-rhinitic control subjects will be studied.
Read the detailed description
After initial screening and verification that subjects can cooperate with active posterior rhinomanometry, subjects will be scheduled for two 15-minute exposure sessions with either: cold-dry air, or warm-moist air. Subjects will rate symptoms (and have their nasal airway resistance measured in triplicate) prior to exposure and at 15-min. intervals post-exposure until an hour has passed.
- Conditions
- Vasomotor Rhinitis
- Being tested
- Cold-dry air provocation, Warm-moist air provocation
- Keywords
- rhinitis, non-allergic rhinitis, rhinomanometry, cold air, triggers: cold, dry air inhalation, warm, most air inhalation, Nonallergic rhinitis; normal controls
- Medical subject headings
- Rhinitis, Vasomotor, Rhinitis, Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold-dry air provocationOther
15 minute exposure to cold-dry air by nasal mask
Warm-moist air provocationOther
15 minute exposure to warm-moist air by nasal mask
| Study group | Role | What they receive |
|---|---|---|
| Order 1 | Experimental | Cold-dry air provocation followed (on a separate day) by Warm-moist air provocation Receives: Other: Cold-dry air provocation; Other: Warm-moist air provocation |
| Order 2 | Experimental | Warm-moist air provocation followed (on a separate day) by Cold-dry air provocation Receives: Other: Cold-dry air provocation; Other: Warm-moist air provocation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net Proportional Change in Nasal Airway Resistance
Net proportional change in nasal airway resistance, pre- to post-exposure, cold air minus warm air day, calculated as a time-weighted average over the 1.0 h post-exposure. At each time point (pre-exposure, immediately post-exposure, and at 15-, 30-, 45- and 60 minutes post-exposure), nasal airway resistance (in Pa/L/sec) was measured in triplicate. The average of each of these measures was taken for each time point. The time-weighted average of these averages was then calculated for the post-exposure time points and compared with the baseline average for that individual on that testing day. The proportional change from baseline on that day was then calculated (unit-less measure). The difference between the pre-to-post change on the cold air day minus the pre-to-post change on the warm air day was then calculated (unit-less measure). The net proportional change corrects for both inter- and intra-individual variability, which in the case of nasal airway resistance is considerable.
Measured: One hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionOct 2007
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vasomotor 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Associated Scientists to Help Minimize Allergies
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington
- Responsible party
- Principal investigator, Stephen A. Tilles MD, Associated Scientists to Help Minimize Allergies
- Investigators
- Dennis Shusterman, MD, MPH, Principal investigator, University of WashingtonStephen A Tilles,, MD, Study director, ASTHMA, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00415493
- Sponsor's protocol ID
- AI-005 NAR
- Status last verified
- Jan 2017
- First submitted
- 21 Dec 2006
- Last updated
- 6 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Physiologic Reactivity of Nonallergic Rhinitics to Cold Air Provocation
- ClinicalTrials.gov ID
- NCT00415493
- Acronym / sponsor ID
- AI-005 NAR
- Conditions
- Vasomotor Rhinitis
- Keywords
- rhinitis, non-allergic rhinitis, rhinomanometry, cold air, triggers: cold, dry air inhalation, warm, most air inhalation, Nonallergic rhinitis; normal controls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Associated Scientists to Help Minimize AllergiesUniversity, hospital or other
- Collaborators
- University of Washington
- Study start
- Dec 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 25 Dec 2006 (estimated)
- Results
- Posted 26 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to compare patients with vasomotor rhinitis ("perennial nonallergic rhinitis," "idiopathic rhinitis") with normal controls with respect to their nasal physiologic reactivity to cold air challenge. Ten vasomotor rhinitis (VMR) patients with nasal symptoms triggered predominantly by cold air, four VMR patients with symptoms triggered predominantly by chemicals, and ten nonallergic, non-rhinitic control subjects will be studied.
Detailed description
After initial screening and verification that subjects can cooperate with active posterior rhinomanometry, subjects will be scheduled for two 15-minute exposure sessions with either: cold-dry air, or warm-moist air. Subjects will rate symptoms (and have their nasal airway resistance measured in triplicate) prior to exposure and at 15-min. intervals post-exposure until an hour has passed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Order 1 | Experimental | Other: Cold-dry air provocation, Other: Warm-moist air provocationCold-dry air provocation followed (on a separate day) by Warm-moist air provocation |
| Order 2 | Experimental | Other: Cold-dry air provocation, Other: Warm-moist air provocationWarm-moist air provocation followed (on a separate day) by Cold-dry air provocation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- (cases; n = 14 total; 10 with predominantly "physical" and 4 with predominantly "irritant"triggers):
- A significant history of chronic and/or recurrent nasal symptoms (rhinorrhea, blockage,sneezing or pruritus) in response to:
Key exclusion criteria (14 listed)
- A significant history of chronic and/or recurrent nasal symptoms (rhinorrhea, blockage,sneezing or pruritus) in response to one or more nonallergic triggers, including: perfumes or colognes, cleaning products, environmental tobacco smoke, vehicular exhaust, paint odors, changes in temperature and/or humidity.
- A prior history of allergic disease (allergic rhinitis, asthma, angioedema, anaphylaxis)
- Significant skin test reactivity to one or more substances in a panel of 24 locally relevant seasonal and perennial aeroallergens
- Negative wheal response to positive control (histamine) on skin test panel
- Abnormalities on a screening x-ray (Waters view) of the paranasal sinuses
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 |
|---|---|---|
| Cold-dry air provocation15 minute exposure to cold-dry air by nasal mask | Other | Order 1, Order 2 |
| Warm-moist air provocation15 minute exposure to warm-moist air by nasal mask | Other | Order 1, Order 2 |
Primary outcome
Net Proportional Change in Nasal Airway Resistance
Time frame: One hour
Net proportional change in nasal airway resistance, pre- to post-exposure, cold air minus warm air day, calculated as a time-weighted average over the 1.0 h post-exposure. At each time point (pre-exposure, immediately post-exposure, and at 15-, 30-, 45- and 60 minutes post-exposure), nasal airway resistance (in Pa/L/sec) was measured in triplicate. The average of each of these measures was taken for each time point. The time-weighted average of these averages was then calculated for the post-exposure time points and compared with the baseline average for that individual on that testing day. The proportional change from baseline on that day was then calculated (unit-less measure). The difference between the pre-to-post change on the cold air day minus the pre-to-post change on the warm air day was then calculated (unit-less measure). The net proportional change corrects for both inter- and intra-individual variability, which in the case of nasal airway resistance is considerable.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Dennis Shusterman, MD, MPH principal investigator
University of Washington
Stephen A Tilles,, MD study director
ASTHMA, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold-dry air provocation and Warm-moist air provocation in people with Vasomotor Rhinitis, run by Associated Scientists to Help Minimize Allergies 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 4 inclusion and 14 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 6 Mar 2017. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Net Proportional Change in Nasal Airway Resistance (time frame: One hour). 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 6 Mar 2017.