MucAct COPD
Research type
Research Study
Full title
What is the clinical effectiveness and cost-effectiveness of nebulised sodium chloride in patients with chronic obstructive pulmonary disease? The MucAct COPD Study.
IRAS ID
281629
Contact name
Adam Hill
Contact email
Sponsor organisation
ACCORD
Eudract number
2020-001949-39
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 9 months, 31 days
Research summary
Research summary
: What is the clinical effectiveness and cost-effectiveness of nebulised 7% sodium chloride in patients with chronic obstructive pulmonary disease? (MucAct COPD Study).
This study looked at ways to help people with chronic obstructive pulmonary disease (COPD) who also have chronic bronchitis and/or bronchiectasis and find it hard to clear mucus from their lungs. It compared two treatments used alongside a breathing exercise called the Active Cycle of Breathing Technique (ACBT). One group used a salty mist (7% saline) inhaled through a nebuliser twice a day, and the other group took an oral medicine called carbocisteine twice a day. Both treatments continued for 12 months.
The main aim was to see which treatment improved participants’ COPD symptoms the most, as measured by the COPD Assessment Test (CAT). Other outcomes included quality of life, number of flare-ups (exacerbations), lung function, safety, and cost.
The study planned to include 860 people across several UK hospitals but was stopped early after COVID-19 made recruitment difficult. A total of 206 participants took part — 104 received carbocisteine, and 102 received nebulised saline. The two groups were similar in age, smoking status, and disease severity.
After 12 months, there was no significant difference between the two treatments in symptom improvement, quality of life, or lung function. However, people using the nebulised saline had fewer flare-ups of their lung condition and went longer before their first flare-up compared to those taking carbocisteine. There was also a trend toward fewer upper respiratory tract infections in the saline group. The saline treatment, however, was more expensive.
In summary, while both treatments improved symptoms similarly, nebulised hypertonic saline helped reduce the number and timing of COPD flare-ups. This suggests that saline nebulisation could be a useful addition to airway clearance therapy for people with COPD and bronchiectasis who struggle to clear mucus, though it comes at a higher cost.Aim(s) of the research
We want to study whether breathing in salty water through a nebuliser can help patients with Chronic Obstructive Pulmonary Disease (COPD) cough up phlegm, make them feel better and cut down the number of chest infections. We also would like to know whether this is better than taking tablets (carbocisteine), also thought to help patients clear phlegm from the airways.
A nebuliser is a machine that creates a mist, which can be inhaled through a mask or tube. The salty water can be inhaled through a nebuliser to help clear excess mucus from the airways.
There is poor evidence of what treatments help clear mucus from the airways. Usually carbocisteine tablets are used (to help clear mucus from the airways). The study investigators believe inhaling salty water is better at clearing mucus from the airways and has additional beneficial effects combating bacterial and viral infection.Background
Some patients with COPD find it hard to clear sputum (phlegm) from the airways. Unfortunately, there’s no good evidence that shows the best treatment for patients.How we will do the study
We will select 860 patients with COPD throughout the UK.
Half of the group, at random, will inhale salty water through a nebuliser twice a day for 1 year. The other half will get carbocisteine tablets daily for 1 year. It is not possible for it to be a blind trial because the participants and clinician will obviously know the treatment given. Both groups will be taught chest clearance using a video of breathing and coughing techniques that they can use twice a day to help clear phlegm from the chest.
The main goal of the study is to see whether inhaled saline is better and is more cost effective than oral carbocisteine which is the traditional medication used. Theoretically, inhaled saline is better than carbocisteine at clearing phlegm in the airways.
Ethics and data protection
The study will only begin following approvals of the multi-centre research ethics committee, approval by the Medicines and Healthcare products Regulatory Agency (MHRA) and management approval.
Data protection will comply with relevant data protection guidelines.
Involving patients and the public
Our grant proposal has been reviewed by the British Lung Foundation (BLF), University of Edinburgh
Patient & Public Involvement (PPI) group based in the Usher Institute and the patient group “Breathtakers, Action for Bronchiectasis”. We amended our plans for the study after getting their feedback. The PPI group also helped with writing this lay summary. A PPI group member has now joined as a co-applicant and two separate members have joined the steering committee for the trial who will link to the BLF patient advisory group.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
21/EM/0074
Date of REC Opinion
13 Apr 2021
REC opinion
Further Information Favourable Opinion