CoughNCT05469555
Azithromycin and Oesophageal Function in Respiratory Disease
An observational study of Cough and Asthma, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Symptoms such as cough, wheeze, and breathlessness are among the most common reasons for general practitioner or emergency department visits in the UK. Such symptoms have a profound impact on patients' ability to live a fulfilled life, often rendering people unable to work and socialise. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- High Resolution Oesophageal Manometry
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Jun 2023to 2 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with chronic respiratory disease whose normal respiratory physician is considering initiating azithromycin therapy for.
Who may be able to join
- Males and females aged ≥18 years.
- Have a diagnosis of chronic respiratory disease (COPD, asthma, interstitial lung disease, chronic cough, cystic fibrosis, and/or bronchiectasis) confirmed by a respiratory consultant.
- Exhibit symptoms consistent with airway reflux, demonstrated by a score ≥14 on the Hull Airways Reflux Questionnaire
- Are being initiated on azithromycin as part of routine clinical care, as judged by their usual respiratory clinician. This will include all common treatment regimes, 250mg once daily, 250mg three times per week, and 500mg three time per week.
- Are willing and able to consent to all study procedures.
Who cannot join
- Previous treatment with long-term macrolides in the past 3 months.
- Unable to be investigated with HROM due to contraindications such as anatomical abnormalities or diseases of the oesophagus or unwilling/ unable to be investigated with HROM based on the clinical judgement of the investigators due to severity of lung disease.
- Have another cardiorespiratory cause for their symptoms (such as heart failure or lung cancer).
- Women of child bearing potential not using effective means of contraception.
- Are unable or unwilling to consent to or complete the study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring the Effect of Azithromycin on Oesophageal Motility and Respiratory Symptoms in Patients With Chronic Respiratory Disease: a Prospective Observational Study
Symptoms such as cough, wheeze, and breathlessness are among the most common reasons for general practitioner or emergency department visits in the UK. Such symptoms have a profound impact on patients' ability to live a fulfilled life, often rendering people unable to work and socialise.
Azithromycin (a type of antibiotic) improves symptoms and reduces flare-ups of diseases such as asthma and chronic obstructive pulmonary disease (COPD). The reason why it works is unclear. Many people believe that it either decreases the number of bacteria in the lungs or reduces inflammation in the lungs and the upper airways. Neither theory is proven. Another possible mechanism that has been much less studied is that Azithromycin encourages the body to move food and fluid through the gut more quickly, thus preventing reflux and aspiration of small food particles and stomach acid. It has been shown that lung damage can occur when gut contents enter the airways, which may contribute chronic lung disease patients' symptoms
Read more
In this study the investigators will test the effect of azithromycin on the gut in patients with chronic lung diseases. The investigators will measure the strength of a patients swallow by measuring the pressures in their gullet, using high-resolution oesophageal manometry (HROM), before and after treatment, in people being started on azithromycin as part of their routine care. The investigators will also measure the effect that azithromycin has on their symptoms and observe whether there is a relationship between the strength of their swallow and their symptoms.
At the end of this study, the investigators hope to better understand the way in which azithromycin helps to improve the symptoms of patients with chronic lung diseases. The investigators also hope to open the door to investigate the effect of other drugs that improve gut function in patients with chronic lung diseases.
- Being tested
- High Resolution Oesophageal Manometry
- Medical subject headings
- Cough, Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Resolution Oesophageal ManometryProcedure or surgery
High Resolution Oesophageal manometry assesses how well the muscles of the oesophagus are working when you swallow. It also checks the relaxation of the valves at the top and bottom of the oesophagus.
What is being measured
The primary outcome is the main question the study is designed to answer.
Eligibility to consent ratio
The ratio of participants deemed eligible to participate in the study to the number of those who provide consent to take part
Measured: 1 year
Recruitment rate
The number of participants successfully recruited per month
Measured: 1 year
Participant retention to follow-up
The proportion of those participants who consent to take part that compete all study measures to follow-up
Measured: 1 year
Acceptability of assessment
Quantify the proportion of participants who judge the study investigations, principally HROM, to be acceptable.
Measured: 1 year
Secondary outcomes (16)
Distal Contractile Integrity
To evaluate the effect of azithromycin on the contraction vigour and swallow coordination. This will be evaluated by investigating patients with HROM before and 1 month after initiation of azithromycin as part of routine clinical care. Measured in mmHg/sec/cm.
Measured: 1 month
Lower Oesophageal Sphincter Pressure
To evaluate the effect of azithromycin on the pressure of the lower oesophageal sphincter as measured by HROM. This will be evaluated by investigating patients with HROM before and 1 month after initiation of azithromycin as part of routine clinical care. Measured in mmHg.
Measured: 1 month
Distal Latency
To evaluate the effect of azithromycin on the timeframe of the wave from the beginning of the swallow to an inflection of the peristaltic axis, as measured by HROM. This will be evaluated by investigating patients with HROM before and 1 month after initiation of azithromycin as part of routine clinical care. Measured in seconds.
Measured: 1 month
Integrated Relaxation Pressure.
To evaluate the effect of azithromycin on the oeosphageal pressure topography metric that is used for assessing the adequacy of oesophageogastric junction relaxation, as measured by HROM. This will be evaluated by investigating patients with HROM before and 1 month after initiation of azithromycin as part of routine clinical care. Measured in seconds.
Measured: 1 month
Chicago Classification
A composite classification based on all HROM measurements. We will be using the current version 4.0.
Measured: 1 month
Hull Airway Reflux questionnaire
A validated tool for assessing symptoms of reflux. A likert scale questionnaire. Scored out of 70 with higher score representing worse symptoms.
Measured: 1 month
Breathlessness, cough, and sputum scale
A validated tool for assessing symptom burden. A 5-point likert scale that is scored out of 12. A higher score representing worse symptoms.
Measured: 1 month
MRC dyspnoea scale
A validated tool for measuring breathlessness. It is scored out out of 5 with a higher score representing worse symptoms.
Measured: 1 month
Visual analogue scale - cough severity
A visual scale of 100mm in length. Participants will mark on the scale from 0-100 how bad their cough is currently with 100mm representing worst cough imaginable.
Measured: 1 month
COPD Assessment test (COPD patients only)
An 8 item questionnaire which quantifies the symptom burden participants with COPD and how it impacts their life. Scored out of 40, with a higher score signifying worse control.
Measured: 1 month
Asthma control questionnaire (asthma patients only)
An 7 item questionnaire which quantifies the symptom burden participants with asthma and how it impacts their life. Scored 5-25 - a score of 5 is very poorly controlled asthma and a score of 25 is very well controlled asthma.
Measured: 1 month
Numerical rating scale - breathlessness severity
A horizontally arranged scale numbered 0-10 with 0 representing no breathlessness and 10 representing the worst breathlessness imaginable
Measured: 1 month
Leicester Cough Questionnaire
A 19-item questionnaire with a 7-point Likert scale used to assess the impact of cough on physical, social, and psychological welfare of the patient. It is scored out of 133 with a higher score representing better health.
Measured: 1 month
St. George's Respiratory Questionnaire
A 50-item questionnaire which assess impact of overall health, daily life, and well-being in patients with obstructive airways disease. Scores range from 0-100, with higher scores indicating more limitations.
Measured: 1 month
King's Brief Interstitial Lung Disease Questionnaire (ILD Patients only)
A 15-item 7-point Likert scale questionnaire aimed to measure the impact of ILD on quality of life and health status. It is scored out of 100, with 100 representing the best health status.
Measured: 1 month
Relationship between oesophageal motility and symptoms
The change in oesophageal functioning and presence of respiratory symptoms will be examined in each participant. The relationship between these two parameters will then be examined using statistical analysis
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start29 Jun 2023
- Primary completion2 Oct 2024
- Study completion2 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05469555
- Sponsor's protocol ID
- 315000
- Status last verified
- May 2025
- First submitted
- 18 Jul 2022
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sykes DL, Brindle K, Menon R, Hart SP, Nielsen J, Jackson W, Gallagher J, Kirton E, Zhang M, Morice AH, Crooks MG. Azithromycin and oesophageal motility in chronic respiratory disease: a feasibility study. Ther Adv Respir Dis. 2025 Jan-Dec;19:17534666251360065. doi: 10.1177/17534666251360065. Epub 2025 Jul 29.
PubMed 40734318
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effect of Azithromycin on Oesophageal Motility and Respiratory Symptoms in Patients With Chronic Respiratory Disease: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05469555
- Acronym / sponsor ID
- 315000
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Study start
- 29 Jun 2023 (actual)
- Primary completion
- 2 Oct 2024 (actual)
- Study completion
- 2 Oct 2024 (actual)
- First posted
- 21 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Symptoms such as cough, wheeze, and breathlessness are among the most common reasons for general practitioner or emergency department visits in the UK. Such symptoms have a profound impact on patients' ability to live a fulfilled life, often rendering people unable to work and socialise.
Azithromycin (a type of antibiotic) improves symptoms and reduces flare-ups of diseases such as asthma and chronic obstructive pulmonary disease (COPD). The reason why it works is unclear. Many people believe that it either decreases the number of bacteria in the lungs or reduces inflammation in the lungs and the upper airways. Neither theory is proven. Another possible mechanism that has been much less studied is that Azithromycin encourages the body to move food and fluid through the gut more quickly, thus preventing reflux and aspiration of small food particles and stomach acid. It has been shown that lung damage can occur when gut contents enter the airways, which may contribute chronic lung disease patients' symptoms
In this study the investigators will test the effect of azithromycin on the gut in patients with chronic lung diseases. The investigators will measure the strength of a patients swallow by measuring the pressures in their gullet, using high-resolution oesophageal manometry (HROM), before and after treatment, in people being started on azithromycin as part of their routine care. The investigators will also measure the effect that azithromycin has on their symptoms and observe whether there is a relationship between the strength of their swallow and their symptoms.
At the end of this study, the investigators hope to better understand the way in which azithromycin helps to improve the symptoms of patients with chronic lung diseases. The investigators also hope to open the door to investigate the effect of other drugs that improve gut function in patients with chronic lung diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with chronic respiratory disease whose normal respiratory physician is considering initiating azithromycin therapy for.
Key inclusion criteria (5 listed)
- Males and females aged ≥18 years.
- Have a diagnosis of chronic respiratory disease (COPD, asthma, interstitial lung disease, chronic cough, cystic fibrosis, and/or bronchiectasis) confirmed by a respiratory consultant.
- Exhibit symptoms consistent with airway reflux, demonstrated by a score ≥14 on the Hull Airways Reflux Questionnaire
- Are being initiated on azithromycin as part of routine clinical care, as judged by their usual respiratory clinician. This will include all common treatment regimes, 250mg once daily, 250mg three times per week, and 500mg three time per week.
- Are willing and able to consent to all study procedures.
Key exclusion criteria (5 listed)
- Previous treatment with long-term macrolides in the past 3 months.
- Unable to be investigated with HROM due to contraindications such as anatomical abnormalities or diseases of the oesophagus or unwilling/ unable to be investigated with HROM based on the clinical judgement of the investigators due to severity of lung disease.
- Have another cardiorespiratory cause for their symptoms (such as heart failure or lung cancer).
- Women of child bearing potential not using effective means of contraception.
- Are unable or unwilling to consent to or complete the study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Resolution Oesophageal ManometryHigh Resolution Oesophageal manometry assesses how well the muscles of the oesophagus are working when you swallow. It also checks the relaxation of the valves at the top and bottom of the oesophagus. | Procedure or surgery | – |
Primary outcome
Eligibility to consent ratio
Time frame: 1 year
The ratio of participants deemed eligible to participate in the study to the number of those who provide consent to take part
Recruitment rate
Time frame: 1 year
The number of participants successfully recruited per month
Participant retention to follow-up
Time frame: 1 year
The proportion of those participants who consent to take part that compete all study measures to follow-up
Acceptability of assessment
Time frame: 1 year
Quantify the proportion of participants who judge the study investigations, principally HROM, to be acceptable.
16 secondary outcomes
Distal Contractile Integrity
Time frame: 1 month
Lower Oesophageal Sphincter Pressure
Time frame: 1 month
Distal Latency
Time frame: 1 month
Integrated Relaxation Pressure.
Time frame: 1 month
Chicago Classification
Time frame: 1 month
Hull Airway Reflux questionnaire
Time frame: 1 month
Breathlessness, cough, and sputum scale
Time frame: 1 month
MRC dyspnoea scale
Time frame: 1 month
Visual analogue scale - cough severity
Time frame: 1 month
COPD Assessment test (COPD patients only)
Time frame: 1 month
Asthma control questionnaire (asthma patients only)
Time frame: 1 month
Numerical rating scale - breathlessness severity
Time frame: 1 month
Leicester Cough Questionnaire
Time frame: 1 month
St. George's Respiratory Questionnaire
Time frame: 1 month
King's Brief Interstitial Lung Disease Questionnaire (ILD Patients only)
Time frame: 1 month
Relationship between oesophageal motility and symptoms
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Derived from this study: PubMed 40734318Sykes DL, Brindle K, Menon R, Hart SP, Nielsen J, Jackson W, Gallagher J, Kirton E, Zhang M, Morice AH, Crooks MG. Azithromycin and oesophageal motility in chronic respiratory disease: a feasibility study. Ther Adv Respir Dis. 2025 Jan-Dec;19:17534666251360065. doi: 10.1177/17534666251360065. Epub 2025 Jul 29.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cough and Asthma, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eligibility to consent ratio (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05469555, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.