Allergic AsthmaNCT01318954
The Effect of Allergen Immunotherapy on Exhaled Nitric Oxide in Adult Patients With Asthma and Allergic Rhinitis
An observational study of Allergic Asthma and Allergic Rhinitis, run by Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C. at 1 site in United States.
Trial summary
This study will evaluate whether exhaled nitric oxide levels are affected by allergen immunotherapy ("allergy shots"). The investigators' hypothesis is that successful allergen immunotherapy may be accompanied by decreased exhaled nitric oxide levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Asthma, Allergic Rhinitis
- What is being tested?
- Allergen immunotherapy
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jun 2011
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with allergic asthma and allergic rhinitis undergoing allergen immunotherapy
Who may be able to join
- Subjects over 18 years old with allergic asthma and/or allergic rhinitis who are beginning allergen desensitization
Who cannot join
- Smokers
- Subjects of dimished capacity
Trial locations and contacts
1 site in 1 country.
United States1 site
Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
Bryn Mawr, Pennsylvania, 19010
About this study
This study will evaluate whether exhaled nitric oxide levels are affected by allergen immunotherapy ("allergy shots"). The investigators' hypothesis is that successful allergen immunotherapy may be accompanied by decreased exhaled nitric oxide levels.
- Conditions
- Allergic Asthma, Allergic Rhinitis
- Being tested
- Allergen immunotherapy
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allergen immunotherapyBiological
| Study group | Role | What they receive |
|---|---|---|
| Subjects on allergen immunotherapy | Measurements of Nitric Oxide by NIOX MINO. This device is now FDA approved. Receives: Biological: Allergen immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of allergen immunotherapy on exhaled nitric oxide
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2011 (estimated)
- Study startJan 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic AsthmaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Columbo, M.D., Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
- Investigators
- Michele Columbo, M.D., Principal investigator, Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01318954
- Sponsor's protocol ID
- F/N-R07-2592B
- Status last verified
- Oct 2015
- First submitted
- 28 Sep 2009
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Allergen Immunotherapy on Exhaled Nitric Oxide in Adult Patients With Asthma and Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT01318954
- Acronym / sponsor ID
- F/N-R07-2592B
- Conditions
- Allergic Asthma, Allergic Rhinitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.University, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 21 Mar 2011 (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.
This study will evaluate whether exhaled nitric oxide levels are affected by allergen immunotherapy ("allergy shots"). The investigators' hypothesis is that successful allergen immunotherapy may be accompanied by decreased exhaled nitric oxide levels.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects on allergen immunotherapy | – | Biological: Allergen immunotherapyMeasurements of Nitric Oxide by NIOX MINO. This device is now FDA approved. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with allergic asthma and allergic rhinitis undergoing allergen immunotherapy
Key inclusion criteria (1 listed)
- Subjects over 18 years old with allergic asthma and/or allergic rhinitis who are beginning allergen desensitization
Key exclusion criteria (2 listed)
- Smokers
- Subjects of dimished capacity
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 |
|---|---|---|
| Allergen immunotherapy | Biological | Subjects on allergen immunotherapy |
Primary outcome
Effect of allergen immunotherapy on exhaled nitric oxide
Time frame: One year
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 29 Oct 2015.
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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.
Michele Columbo, M.D. principal investigator
Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Asthma and Allergic Rhinitis, run by Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C. 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 1 inclusion and 2 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 29 Oct 2015. 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?
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?
Effect of allergen immunotherapy on exhaled nitric oxide (time frame: One year). 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 29 Oct 2015.