|- candidate number||5583|
|- NTR Number||NTR1756|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||9-apr-2009|
|- Secondary IDs||P08.237 METC LUMC|
|- Public Title||ASTHMA CONTROL COST-UTILITY RANDOMIZED TRIAL EVALUATION. |
|- Scientific Title||ASTHMA CONTROL COST-UTILITY RANDOMIZED TRIAL EVALUATION. |
|- hypothesis||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.
|- Healt Condition(s) or Problem(s) studied||Asthma|
|- 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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2008|
|- planned closingdate||1-jun-2011|
|- Target number of participants||720|
|- 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.
|- Primary outcome||Pharmaco-economics:|
1. Net health benefit;
|- Secondary outcome||1. Patient preferences; |
3. Asthma related quality of life;
4. The number of limited activity days;
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.
|- Timepoints||Baseline, 3months, 6 months, 9months, 12 months + unplanned visits.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| P.J. Honkoop|
|- CONTACT for SCIENTIFIC QUERIES||PhD. MD. Jaap K. Sont|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, Longfonds The Netherlands , Aerocrine AB |
|- Brief 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.
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).
|- Main changes (audit trail)||22-06-09: Added to secondary outcomes: |
- Smokers vs. Non-smokers
- 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)
- Exhaled Nitric Oxide status at baseline, subdivided into low(<25), medium(25-50) and high(>50))
- Allergic vs. non-allergic Asthma
- BMI ≤ 30 vs BMI > 30.
14-Nov-2012: In our protocol we anticipated a participation rate per cluster of six asthma patients. In reality the participation rate during the inclusion phase proved to be lower, with a mean of 4.7 patients per cluster. Therefore, we increased the number of clusters (general practices) from 120 to 131 clusters in our study in order to preserve the required power. By using a mathematical model of iso-power lines, showing the trade-off between the number of patients per cluster and the total number of clusters required for a given power, we showed that the actual study size of 131 clusters with on average 4.7 patients yields the same power as the planned study size of 120 clusters with 6 patients.
30-1-2014: In the original protocol to the dutch governmental organisation Zon-MW we had a planned date of start for our study in June 2008, which is also described in this register (planned startdate). Unfortunately, we experienced a delay in the start of our study, since one of the participating centers (Academic Medical Center, Amsterdam), had a change in staff and needed time to re-evaluate the decision to participate. Furthermore, the decision to approve our study at the Medical Ethics Committee took more time as planned. Therefore the actual start of the first participant of our study was July 2009.
|- RECORD||9-apr-2009 - 30-jan-2014|