AsthmaNCT00149474
Peak Flow Monitoring in Older Adults With Asthma
A study testing Peak Flow Monitoring in people with Asthma, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
Evaluate the incremental effectiveness of peak flow monitoring ove symptom monitoring as a management tool to enhance asthma control in adults >= 50 years with moderate-severe asthma. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Asthma
- What is being tested?
- Peak Flow Monitoring
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Aug 1994to Jul 1999
- Phase
- Interventional
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusions: Doctor-diagnosed asthma; >=50 years; using asthma medications; >12% increase in FEV1 after two puffs of inhaled beta-agonist; willing to participate in asthma meducation program and two-year follow up; likely to stay in Portland area; KPNW member for two years.
Exclusions: Unable to read, speak or understand English; no telephone; failure to keep two pre-randomization appointments; inability to reproducible FEV 1 maneuver; participation in pilot phase of study; concurrent participation in any other medical research study.
About this study
Evaluate the incremental effectiveness of peak flow monitoring ove symptom monitoring as a management tool to enhance asthma control in adults >= 50 years with moderate-severe asthma.
Read the detailed description
BACKGROUND:
We propose a five-year Demonstration and Education project to assess the incremental value of peak flow monitoring (PFM) over symptom monitoring (SM) as a management tool for asthma control in adults greater than or equal to 50 years with moderate-severe asthma. We will develop three parallel asthma education programs for older adults using as our base an existing asthma education program (AIR/Kaiser Adult Education Program) of demonstrated efficacy for adults ,50 years of age.
DESIGN NARRATIVE:
Primary outcome Frequency and cost of health care utilization for asthma, and asthma-specific quality of life
Key secondary outcomes Prebronchodilator FEV1; diurnal variability in PEF
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Asthma
- Being tested
- Peak Flow Monitoring
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peak Flow MonitoringBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startAug 1994
- Study completionJul 1999
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.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- 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
- Allocation
- Randomised
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00149474
- Sponsor's protocol ID
- 260
- Other IDs
- R01HL052598
- Status last verified
- Sep 2005
- First submitted
- 6 Sep 2005
- Last updated
- 18 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peak Flow Monitoring in Older Adults With Asthma
- ClinicalTrials.gov ID
- NCT00149474
- Acronym / sponsor ID
- 260
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Aug 1994
- Study completion
- Jul 1999 (actual)
- First posted
- 8 Sep 2005 (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.
Evaluate the incremental effectiveness of peak flow monitoring ove symptom monitoring as a management tool to enhance asthma control in adults >= 50 years with moderate-severe asthma.
Detailed description
BACKGROUND:
We propose a five-year Demonstration and Education project to assess the incremental value of peak flow monitoring (PFM) over symptom monitoring (SM) as a management tool for asthma control in adults greater than or equal to 50 years with moderate-severe asthma. We will develop three parallel asthma education programs for older adults using as our base an existing asthma education program (AIR/Kaiser Adult Education Program) of demonstrated efficacy for adults ,50 years of age.
DESIGN NARRATIVE:
Primary outcome Frequency and cost of health care utilization for asthma, and asthma-specific quality of life
Key secondary outcomes Prebronchodilator FEV1; diurnal variability in PEF
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
- Allocation
- Randomised
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Peak Flow Monitoring | Behavioural | – |
Primary outcome
Not reported in the source record.
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 18 Feb 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Peak Flow Monitoring in people with Asthma, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 18 Feb 2016. 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.
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 18 Feb 2016.