No registrations found.
ID
Source
Brief title
Health condition
Asthma
Sponsors and support
- Netherlands Asthma Foundation (NAF 3.4.07.044)
- Aerocrine (medical technology company)
Intervention
Outcome measures
Primary outcome
Pharmaco-economics:
1. Net health benefit;
2. Cost-effectiveness;
3. Cost-utility.
Secondary outcome
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 <0.75, 0.75-1.5, >1.5 (Juniper et al. Resp.Med.2006);
3. Exhaled Nitric Oxide status at baseline, subdivided into low(<25), medium(25-50) and high(>50));
4. Allergic vs. non-allergic Asthma;
5. BMI < 30 vs BMI > 30.
Background summary
Rationale:
The central question is whether an attempt to achieve complete control of all features of asthma, with accompanying high dosis of medication should be made, and whether patients and society value the potential incremental benefit sufficiently to concur with such a treatment approach. Therefore the aim of the study is to assess patient preferences and cost-effectiveness of two treatment strategies aimed at achieving different levels of clinical control:
1. Partly controlled asthma;
2. Controlled asthma.
A third strategy adds a nitric oxide measurement:
3. Controlled asthma based on exhaled nitric oxide as an additional disease marker.
In the third treatment strategy an algorithm was designed that combines the results of an NO-measurement and the composite score measurements. The question is whether this leads to better asthma control in a general practice population and whether it is a cost-effective addition.
Methods:
720 Patients with mild to moderate persistent asthma from general practices with a nurse practitioner or physician assistant, age 18-50 yr, need for daily treatment with inhaled corticosteroids (more then 3 months usage of inhaled corticosteroids in the previous year), will be identified via primary care patient registries, including Leiden, Nijmegen and Amsterdam areas. The design is a cluster-randomised trial with 40 general practices in all three arms and 12 months follow-up. The patients will visit the general practice at baseline, 3, 6, 9 and 12 months. At each planned and unplanned visit to the general practice treatment will be adjusted with support of an ICT-based asthma monitoring system supervised by a central coordinating specialist nurse. Patient preferences and utilities will be assessed by questionnaire and interview. Data on asthma control, treatment step, adherence to treatment, utilities and costs will be obtained every 3 months. Differences in societal costs (medication, other (health) care and productivity) will be compared to differences in the number of limited activity days and in quality adjusted life years (Dutch EQ5D, SF6D, e-TTO, VAS).
Study objective
1. A treatment strategy aimed at well controlled asthma is more (cost-)effective as compared to a treatment strategy aimed at achieving partly controlled asthma;
2. A treatment strategy aimed at well controlled asthma is (cost-)effective when the treatment step is additionally guided by measurements of exhaled nitric oxide (NO) as compared to a treatment strategy aimed at achieving well controlled asthma or partly controlled asthma.
Study design
Baseline, 3months, 6 months, 9months, 12 months + unplanned visits.
Intervention
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.
P.O.box 9600
P.J. Honkoop
Leiden 2300 RC
The Netherlands
+31 (0)71 5264904
P.J.Honkoop@lumc.nl
P.O.box 9600
P.J. Honkoop
Leiden 2300 RC
The Netherlands
+31 (0)71 5264904
P.J.Honkoop@lumc.nl
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
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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1658 |
| NTR-old | NTR1756 |
| Other | METC LUMC : P08.237 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |