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Inhalation mit Ambroxol zur Schleimlösung bei Patient:innen auf der Palliativstation - eine randomisierte Placebo-kontrollierte Doppelblind-Pilotstudie

Titel Inhalation mit Ambroxol zur Schleimlösung bei Patient:innen auf der Palliativstation - eine randomisierte Placebo-kontrollierte Doppelblind-Pilotstudie
Beginn Datum 02.08.2021
Voraussichtliches Ende 01.04.2023
Institutionen AKH Wien
Projektleitung Assoc. Prof. PD Dr. Eva Katharina Masel, MSc
E-mail jakob@jdonath.de
Abstract

Palliative care aims for the best individual solution for patients with life- limiting diseases. Therefore, the control of burdensome symptoms is a main task of this field. Beside pain, malnutrition, cachexia, sarcopenia, anxiety and depression, dyspnoea occurs frequently with patients in a palliative setting while airway mucus hypersecretion (AMH) is an accompanying symptom of dyspnoea.

This study will be a randomised double-blind placebo-controlled pilot trial where one group of patients with AMH will be treated with ambroxol hydrochloride and sodium chloride inhalation (ABX) and the other group with sodium chloride inhalation solely (SC).

ABX and for the control group SC will be administered for inhalation twice a day for five days. For all study participants, one day before the intervention (day -1), pulmonary function testing will be performed through a spirometry. Primary endpoint will be the subjective feeling of the patients, which will be measured with the patient global impression of change (PGIC) and the Leicester Questionnaire (LCQ). The patients will be handed out the these questionnaires on day -1, day 3 and day 6. To further measure the success of the intervention, exacerberated mucus will be collected once daily (day1- day5) after inhalation. The collected mucus will be weighed in grams and serve as secondary endpoint as will the exacerbarations volume. Further secondary endpoints will be the results from the spirometry.

Seven days after the intervention (day +12), pulmonary function testing will be performed again and all primary and secondary endpoints will be collected repeatedly and compared with the results before the intervention.

 

Stellungnahme der Ethikkommission genehmigt
Datum der Stellungnahme der Ethikkommission 06.07.2021
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Disziplin/-en
  • - Palliativmedizin
  • - Palliativpharmazie
Status Rekrutierung läuft
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