Ambroxol inhalation for mucus clearance in palliative care patients - a randomized placebo-controlled double-blind pilot study.

INTERVENTION: Trade Name: Ambroxol Pharmaceutical Form: Inhalation solution CAS Number: 15942‐05‐9 Current Sponsor code: Ambroxpall Other descriptive name: AMBROXOL HYDROCHLORIDE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 7.5‐ Pharmaceutical form of the placebo: Inhalation solution Route of administration of the placebo: Inhalation use CONDITION: cancer Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: Secondary Objective: Secondary objectives: ; ‐ Oxygen saturation (SpO2); ‐ spirometry (FEV1); ‐ Ejection weight of mucus (measured with a tare scale in grams); ‐ Ejection volume of mucus (in milliliters); ‐ Leicester Cough Questionnaire (LCQ) Questionnaire( 7); These endpoints aim to determine whether and how inhaled therapy affects the above variables. The LCQ questionnaire is used for further, more precise determination of the patient's assessment.; ; Main Objective: The main study objective is to assess subjective respondent ratings. Timepoint(s) of evaluation of this end point: after 12 weeks Primary end point(s): The primary endpoint is the Patients' Global Impression of Change (PGIC) questionnaire (6).; This questionnaire is designed to assess how therapy with ABX affects the subjective well‐being of patients with regard to symptom burden caused by the symptom "airway congestion". SECONDARY OUTCOME: Secondary end point(s): no Timepoint(s) of evaluation of this end point: na INCLUSION CRITERIA: Patients over 18 years of age, ‐ No pregnancy ‐ History of more than three sputum sputum sputum sputum sputum sputum sputum sputum sputum sputum sputum per day, ‐ No mucolytic medication ‐ No reasons for non‐participation (e.g., cognitive deficit, delirium, marked dementia or severe psychiatric illness, excessively poor performance status, severe septicemia with impaired consciousness, intolerance of ABX) ‐ No language barrier ‐ Given ability to sign verbal as well as written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10