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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00149474
Other study ID # 260
Secondary ID R01HL052598
Status Completed
Phase N/A
First received September 6, 2005
Last updated February 17, 2016
Start date August 1994
Est. completion date July 1999

Study information

Verified date September 2005
Source National Heart, Lung, and Blood Institute (NHLBI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date July 1999
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 50 Years to 90 Years
Eligibility 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.

Study Design

Allocation: Randomized


Related Conditions & MeSH terms


Intervention

Behavioral:
Peak Flow Monitoring


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
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