AsthmaNCT00939354
Asthma in the Elderly: The Role of Exhaled Nitric Oxide Measurements
An observational study of Asthma, run by Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C..
Trial summary
This study will investigate the importance of exhaled nitric oxide measurements in subjects with asthma age 65 and older. This group of patients has been ignored in most previous asthma studies. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Asthma
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to Feb 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Subjects with asthma over the age of 65 who are currently followed in our practice
Who may be able to join
- Subjects with asthma over the age of 65 followed in our practice, non-smokers and able to give informed consent to participate in the study
Who cannot join
- Smokers, subjects of diminished mental capacity
About this study
This study will investigate the importance of exhaled nitric oxide measurements in subjects with asthma age 65 and older. This group of patients has been ignored in most previous asthma studies.
- Conditions
- Asthma
- Keywords
- Asthma in subjects over the age of 65
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
Exhaled Nitric Oxide (FENO) levels and their changes with time
Measured: One year
Secondary outcomes (1)
Correlations of FENO with subjects' demographics, comorbidities, treatment, symptoms, or spiromentric values
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 posted15 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 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
- Albert S Rohr, M.D., Principal investigator, Rohr and Columbo Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00939354
- Sponsor's protocol ID
- F/N-R09-2839B
- Status last verified
- Oct 2015
- First submitted
- 14 Jul 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
- Asthma in the Elderly: The Role of Exhaled Nitric Oxide Measurements
- ClinicalTrials.gov ID
- NCT00939354
- Acronym / sponsor ID
- F/N-R09-2839B
- Conditions
- Asthma
- Keywords
- Asthma in subjects over the age of 65
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.University, hospital or other
- Study start
- Jul 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 15 Jul 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.
This study will investigate the importance of exhaled nitric oxide measurements in subjects with asthma age 65 and older. This group of patients has been ignored in most previous asthma studies.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Subjects with asthma over the age of 65 who are currently followed in our practice
Key inclusion criteria (1 listed)
- Subjects with asthma over the age of 65 followed in our practice, non-smokers and able to give informed consent to participate in the study
Key exclusion criteria (1 listed)
- Smokers, subjects of diminished mental capacity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Exhaled Nitric Oxide (FENO) levels and their changes with time
Time frame: One year
1 secondary outcome
Correlations of FENO with subjects' demographics, comorbidities, treatment, symptoms, or spiromentric values
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.
Albert S Rohr, M.D. principal investigator
Rohr and Columbo Associates
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C..
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 1 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.
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?
Exhaled Nitric Oxide (FENO) levels and their changes with time (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.