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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-004377-44-AT

Enrollment

Registered

2021-07-13

Start date

2021-08-24

Completion date

Unknown

Last updated

2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: none

Design outcomes

Primary

Measure	Time frame
Main Objective: The main study objective is to assess subjective respondent ratings. ;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. ;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". ;Timepoint(s) of evaluation of this end point: after 12 weeks	—

Measure

Time frame

Main Objective: The main study objective is to assess subjective respondent ratings. ;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. ;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". ;Timepoint(s) of evaluation of this end point: after 12 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): no;Timepoint(s) of evaluation of this end point: na	—

Countries

Austria

Contacts

Public ContactEva Katharina Masel

Med. Univ. Wien, Innere Med. I, Abt. f. Palliativmedizin

eva.masel@meduniwien.ac.at+4314040077800

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026