Nebulized morphine for breathlessness in chronic obstructive pulmonary disease

Dosimetrically administered nebulized morphine for breathlessness in very severe chronic obstructive pulmonary disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14865597

Enrollment

Registered

2017-03-23

Start date

2014-03-04

Completion date

Unknown

Last updated

2018-08-20

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

Conditions

Breathlessness in very severe chronic obstructive pulmonary disease Respiratory Chronic obstructive pulmonary disease

Interventions

Patients are randomly assigned to two treatment sequences using online software for simple randomization (Research Randomizer ver. 3.0). Each sequence lasts for eight days and consists of two periods

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age above 50 years 2. COPD group D, according to 2013 Global Initiative For Chronic Obstructive Lung Disease (GOLD) guidelines 3. Stage IV airflow limitation i.e. FEV1% < 30%, according to 2011 GOLD classification 4. Breathlessness rated 3 or 4 in the modified Medical Research Council scale (mMRC) breathlessness scale 5. Current non-smoker 6. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Other coexisting severe chronic lung diseases, such as lung cancer 2. Breathlessness caused by other than COPD chronic diseases, such as heart failure or renal failure 3. Inability to give informed consent 4. previous history of respiratory depression after opioid administration or allergic reactions to opioids 5. Ongoing opioid treatment for any indication 6. COPD exacerbation within the last month

Design outcomes

Primary

Measure	Time frame
Intensity of breathlessness, measured by visual analogue scale (VAS) 15-30 minutes before the nebulisation, immediately after the nebulisation and 15 minutes, 30 minutes, 1, 2, 3 and 4 hours after the nebulization.	—

Secondary

Measure	Time frame
1. Most effective dose of morphine is noted when =20 mm drop in VAS is detected 2. Exercise tolerance is measured using the Wilcock’s test 15-30 minutes before and 2 hours after nebulization 3. Safety is assessed by measuring heart rate, respiratory rate and peripheral capillary oxygen saturation at the same time points as VAS, and spirometry and peak expiratory flow (PEF) one hour before and one hour after nebulisation	—

Measure

Time frame

1. Most effective dose of morphine is noted when =20 mm drop in VAS is detected 2. Exercise tolerance is measured using the Wilcock’s test 15-30 minutes before and 2 hours after nebulization 3. Safety is assessed by measuring heart rate, respiratory rate and peripheral capillary oxygen saturation at the same time points as VAS, and spirometry and peak expiratory flow (PEF) one hour before and one hour after nebulisation

—

Countries

Poland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 25, 2026