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ASTHMA CONTROL COST-UTILITY RANDOMIZED TRIAL EVALUATION.

ASTHMA CONTROL COST-UTILITY RANDOMIZED TRIAL EVALUATION.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22219
Enrollment
720
Registered
2009-04-09
Start date
2009-07-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Interventions

1. PC-strategy: aiming to achieve partly controlled asthma based on asthma control measures
2. C-strategy: aiming to achieve controlled asthma based on asthma control measures
3. FeNO-strategy: aiming to achieve controlled asthma based on asthma control measures and an indirect marker of airways inflammation.

Sponsors

-
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18-50 yr; 2. Doctors diagnosis of asthma; 3. A prescription of inhaled corticosteroid treatment in the last year; 4. Willing to change treatment step in order to follow the protocol; 5. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Daily or alternate day oral corticosteroid therapy within 1 month before entering the study; 2. Inability to understand written or oral Dutch instructions; 3. Active diseases likely to interfere with the purpose of the study.

Design outcomes

Primary

MeasureTime frame
Pharmaco-economics: 1. Net health benefit; 2. Cost-effectiveness; 3. Cost-utility.

Secondary

MeasureTime frame
1. Patient preferences; 2. Compliance; 3. Asthma related quality of life; 4. The number of limited activity days; 5. Exacerbations; Preplanned subgroupanalyses: 1. Smokers vs. Non-smokers; 2. Asthma control at baseline subdivided into strict, partly, or uncontrolled by Juniper Asthma Control Questionnaire scores of respectively 1.5 (Juniper et al. Resp.Med.2006); 3. Exhaled Nitric Oxide status at baseline, subdivided into low(50)); 4. Allergic vs. non-allergic Asthma; 5. BMI 30.

Contacts

Public ContactP.J. Honkoop

Department of Medical Decision Making, J10-87 P.O.box 9600

P.J.Honkoop@lumc.nl+31 (0)71 5264904

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)