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De dosis Salbutamol (Ventolin) bij de reversibiliteitsmeting

The doses Salbutamol (Ventolin) during the reversibility measurement



- candidate number27809
- NTR NumberNTR6672
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-aug-2017
- Secondary IDsNL61496.098.17 METC ZWH HagaZiekenhuis
- Public TitleDe dosis Salbutamol (Ventolin) bij de reversibiliteitsmeting

The doses Salbutamol (Ventolin) during the reversibility measurement
- Scientific TitleDe dosis Salbutamol (Ventolin) bij de reversibiliteitsmeting

The doses Salbutamol (Ventolin) during the reversibility measurement
- ACRONYMDo-Re-Mi-study
- hypothesisHet doel van het onderzoek is het onderzoeken of de huidige standaard dosis Salbutamol van 400Ķg, gereduceerd kan worden naar een dosis van 200Ķg Salbutamol.

The objective of this trial is to determine wether the current standard doses Salbutamol 400 ug can be reduced to a doses Salbutamol 200 ug.
- Healt Condition(s) or Problem(s) studiedCOPD, Asthma
- Inclusion criteria- Age >18 years - < 80 years.
- Referral for diagnostic Asthma/COPD
- Referral by GP for diagnostic Asthma/COPD
- No previous treatment for lungconditions
- Signed informed consent.
- Understanding of the informed consent form.
- Exclusion criteria- Use of Beta2-sympathicomimetica <6 hour prior to measurement.
Use of anticholinergica <12 hour prior to measurement.
- Patient unable to comply to instructions
- Patient decides to withdraw participation
- lungfunctionanalist decides for the patient to withdraw participation
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 18-sep-2017
- planned closingdate18-sep-2018
- Target number of participants170
- Interventionsn/a
- Primary outcomeFEV1 (L)
- Secondary outcomeFVC (L) en subjective dyspnea
- Timepointsn/a
- Trial web siten/a
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Sylvie Caron
- CONTACT for SCIENTIFIC QUERIES
- Sponsor/Initiator Haga Hospital
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summary
- Main changes (audit trail)This research is to measure de doserespons of Salbutamol by adults with asthma and chronic obstructive pulmonary disease. The setup of the research is to investigate if the dose of 200ug Salbutamol the same reversibility shows as the standard dose of 400ug Salbutamol.
The patiŽnts will come to the hospital for a lungfunctiontest. The spirometry will take place under the same conditions as usual, the only thing that difference is that there will be performed an extra spiromety at the day of visit. The participation to the trail stops the moment the patiŽnts have finished to carry out the spirometry correctly.
The doserespons will be measured by the following parameters: FEV1, FVC, FEV1/FVC and subjective dyspnea.
- RECORD31-aug-2017 - 21-sep-2017


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