WheezingNCT05447832
Remote Monitoring in Preschool Wheeze
An observational study of Wheezing and Respiratory Sounds, run by Imperial College London at 2 sites in United Kingdom.
Trial summary
The aim of this project is to fill the significant unmet healthcare need to prevent wheeze attacks in preschool children. This will be achieved by developing a proof-of-concept, bespoke home remote objective monitoring system for preschool children that can identify early signs before a wheeze attack to allow early… Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Wheezing, Respiratory Sounds
- What is being tested?
- Lung function monitoring equipment at home - 2 weeks, Lung function monitoring equipment at home - 4 months and Inflammation and remodelling from clinical indicted bronchoscopy
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Aug 2022to 29 Mar 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 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 1-5 years with recurrent wheezing selected from the hospital emergency department and electively investigations.
Who may be able to join
- Children aged 1-5 years
- Doctor diagnosed and confirmed wheeze
- At least one previous attack of wheeze in the previous year
- Parents/carers with access to a smart phone or computer (to allow data to be entered into the online questionnaire)
Who cannot join
- Prematurity < 34 weeks gestation
- Need for ventilation in the first seven days after birth
- Known cardiac disease
- Known diagnosis of another respiratory condition (e.g. cystic fibrosis, bronchiectasis)
Trial locations and contacts
2 sites in 1 country.
Karina Mayoral, MPH contact
United Kingdom2 sites
Royal Brompton and Harefield NHS Foundation Trust
London, SW3 6NP
Sejal Saglani, MD, +442075943167, s.saglani@imperial.ac.uk
Imperial College Healthcare NHS Trust
London, W2 1BL
Adnan Custovic, MD, a.custovic@imperial.ac.uk
About this study
Official title: Remote Monitoring to Predict and Prevent Asthma Attacks in Preschool Children
The aim of this project is to fill the significant unmet healthcare need to prevent wheeze attacks in preschool children. This will be achieved by developing a proof-of-concept, bespoke home remote objective monitoring system for preschool children that can identify early signs before a wheeze attack to allow early intervention and prevention. This study aims to develop methods for recognising child-specific abnormal patterns in time-course lung function data, and wheeze onset providing early warning of deterioration. The prototype system is targeted for use by caregivers of preschool children with wheeze, and will integrate the individual child's information about symptoms, medication use and lung function to alert parents to seek healthcare advice to prevent hospitalisation.
Read the detailed description
Asthma is the most common childhood non-infectious lung disease in the United Kingdom, affecting ~8% of children. Asthma symptoms include wheezing (a high-pitched whistling sound created by turbulent airflow through narrowed airways) associated with difficulty in breathing and shortness of breath, often with a dry cough. Asthma is characterised by episodic (wheeze attacks) and variable symptoms which fluctuate day-to-day. An asthma, or wheeze attack, is a sudden worsening of symptoms, associated with airway obstruction that requires treatment to open up the airways.
Preschool children (aged 1-5 years) account for the majority (75%) of hospital admissions for acute attacks of wheezing in the UK. Up to half of all preschool children will suffer at least one episode of wheezing by their 6th birthday, and 7.8% of preschool children came to primary care with acute wheezing in 2017 in the UK. Frequent severe wheeze attacks in preschool age are the strongest risk factor for diminished lung function at physiological peak in early adulthood and are associated with chronic obstructive pulmonary disease (COPD) in the sixth decade of life, as well as early all-cause mortality and cardiovascular and metabolic comorbidities. It is therefore vital to prevent wheeze attacks in preschool children.
Preschool children experience a 5-times higher rate of hospitalisation for acute wheeze attacks compared to school-aged children. This suggests overt symptoms present late, and not soon enough, for early intervention to prevent attacks in preschool children. The number of unscheduled healthcare presentations of acute wheeze attacks has not decreased for the last 2 decades for preschool children, while it has been declining for school-aged children and adults, resulting in a high socioeconomic burden in the UK and worldwide.
Failure to prevent wheeze attacks in preschool children is in part due to the absence of age-specific remote and objective monitoring technology for disease severity. Currently, in this age group, symptoms are diagnosed and monitored by subjective assessments of airway obstruction (narrowing). Evidence that the symptoms improve following treatment with inhaled bronchodilators is used as an indirect indication of the presence of reversible airway obstruction, which is a cardinal feature of asthma. In school-aged children and adults, airway obstruction is monitored objectively with lung function tests such as spirometry. Spirometry can be performed remotely at home to aid telemedicine monitoring in asthma. However, spirometry requires a forced expiratory manoeuvre and cooperation from the patient. It can thus only be reliably performed in children over 5 years old. As a result, diagnosis and monitoring of wheezing/asthma in preschool children depends on parental reports, clinical examination and subjective assessment of symptoms, but no objective measures of airway obstruction.
For this study, time-course lung function data will be obtained using a novel home-based wearable device designed for preschool children that detects airway obstruction whilst the child is asleep (Ventica®). Also, eliciting objective confirmation of wheeze will be obtained by the use of the WheezeScan® device, which detects presence/absence of wheeze when placed on the child's chest. This information will contribute to developing an app that combines symptoms, medication use, and lung function to allow wheeze detection and provide a personalised plan for parents to seek healthcare advice.
STUDY HYPOTHESES
- A mobile-based system integrating data on remote lung function, symptoms and medication use can be used to predict the development of an acute attack of wheeze in children aged 1-5 years.
- The dynamic change in lung function reflects underlying airway pathology in severe wheezing
STUDY OBJECTIVES
- To develop a mobile app system that collects data on lung function, symptoms and medication use, and returns personalised prediction for preschool wheezers, empowering parents to self-manage their child's wheeze/asthma.
- To quantify airway inflammation and remodelling in endobronchial biopsies and broncho-alveolar lavage from a subgroup of preschool children with severe wheezing and relate pathology to the pattern of airway obstruction detected using the Ventica® system.
- To develop prediction models that integrate patient-specific abnormal patterns in time-course lung function data, symptoms recorded using with and without WheezeScan®, and rescue medication use, providing early warning of deterioration.
- Conditions
- Wheezing, Respiratory Sounds
- Being tested
- Lung function monitoring equipment at home - 2 weeks, Lung function monitoring equipment at home - 4 months, Inflammation and remodelling from clinical indicted bronchoscopy
- Keywords
- Preschool Wheeze, Asthma Attack
- Medical subject headings
- Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung function monitoring equipment at home - 2 weeksDevice
The parent/carer setup the lung function monitoring equipment (Ventica®), and placed the WheezeScan® device on the child's chest at home before the child goes to sleep. This is performed once daily for 2 weeks.
Lung function monitoring equipment at home - 4 monthsDevice
The parent/carer setup the lung function monitoring equipment (Ventica®), and placed the WheezeScan® device on the child's chest at home before the child goes to sleep. This is performed once weekly for 4 months.
Inflammation and remodelling from clinical indicted bronchoscopyDiagnostic test
For patients who are undergoing clinically indicated bronchoscopy, consent will be obtained to use any surplus clinical samples for this study. The samples to be collected are broncho-alveolar lavage and endobronchial biopsies. Both of these are taken from the airways during clinical bronchoscopy.
| Study group | Role | What they receive |
|---|---|---|
| 1/Children aged between 1-5 years from the emergency department | Children who have attended the emergency department at St Mary's Hospital, with an acute attack of wheezing. These families will be asked to use the lung function monitoring and the wheeze detection device every night for 2 weeks, while recording symptoms and medication use in the last 24 hours. Receives: Device: Lung function monitoring equipment at home - 2 weeks | |
| 2/Children aged between 1-5 years admitted electively for wheezing investigation | Children who have been admitted electively for investigations of their wheezing at the Brompton Hospital. These children/families will be asked to do the lung function monitoring and the wheeze detection device once per week for 4 months, while recording symptoms and medication use in the last 24 hours. Receives: Device: Lung function monitoring equipment at home - 4 months; Diagnostic Test: Inflammation and remodelling from clinical indicted bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relation of lung function to symptoms and medication use (Group 1)
The lung function measured with the Ventica® system measures tidal breathing variability (non-invasive) in order to assist with the diagnosis and monitoring of asthma or asthmatic symptoms in children aged five years and under. It includes 4 electrodes that are placed under the child's arms - with wires that connect to a small recorder, which is included in a vest that is worn overnight. The presence of wheeze would be detected with the WheezeScan® device, this device needs to be placed on the child's chest for 30-60 seconds and it will confirm if wheezing is present. This will be used by families either when they think their child has symptoms or routinely just prior to the lung function monitoring equipment being used. Both devices include European Conformity (CE) certification and are available for purchase commercially. Symptoms and medication use will be collected using an online secure questionnaire that will be accessible from a computer or a mobile phone.
Measured: 2 weeks
Relation of lung function to symptoms and medication use (Group 2)
The lung function measured with the Ventica® system measures tidal breathing variability (non-invasive) in order to assist with the diagnosis and monitoring of asthma or asthmatic symptoms in children aged five years and under. It includes 4 electrodes that are placed under the child's arms - with wires that connect to a small recorder, which is included in a vest that is worn overnight. The presence of wheeze would be detected with the WheezeScan® device, this device needs to be placed on the child's chest for 30-60 seconds and it will confirm if wheezing is present. This will be used by families either when they think their child has symptoms or routinely just prior to the lung function monitoring equipment being used. Both devices include European Conformity (CE) certification and are available for purchase commercially. Symptoms and medication use will be collected using an online secure questionnaire that will be accessible from a computer or a mobile phone.
Measured: 4 months
Relation of lung function to airway pathology (Group 2)
Information of patients having a planned bronchoscopy will be collected, to relate airway inflammation and remodelling in bronchial biopsies and broncho-alveolar lavage to the pattern of airway obstruction detected using the Ventica® lung function monitoring system. The endobronchial biopsies will quantify the changes that may cause a child to have wheezing, this includes the amount of mucus, smooth muscle and collagen in the biopsy. The results from these analyses will be related to the lung function measurements, to assess whether specific types of changes in the airway samples relate to specific types of changes in lung function.
Measured: 4 months
Develop a prototype app that combine symptoms, medication use and lung function
The mobile app system will collect data on lung function, symptoms and medication use, and will return personalised predictions for preschool wheezers. The prediction model of attacks and loss of symptom control will be trained using the longitudinal data obtained from the children in the study. Change in lung function, and time to normalisation following treatment for wheezing, will be assessed to understand the time taken for full recovery, and whether persistently abnormal lung function, without overt symptoms, may be an early and sensitive sign for a future attack. The relative contributions of each parameter (symptoms, medication use, wheeze detection, lung function, lower airway inflammation) in determining the accuracy of the model will be assessed to determine the added value of lung function monitoring in predicting individualised patterns of loss of control.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study startAug 2022 (estimated)
- Primary completion29 Nov 2023 (estimated)
- Study completion29 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WheezingStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Engineering and Physical Sciences Research Council, UK
- Responsible party
- Principal investigator, Sejal Saglani, Imperial College London
- Investigators
- Sejal Saglani, MD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05447832
- Sponsor's protocol ID
- 307300
- Status last verified
- Jul 2022
- First submitted
- 23 Jun 2022
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Monitoring to Predict and Prevent Asthma Attacks in Preschool Children
- ClinicalTrials.gov ID
- NCT05447832
- Acronym / sponsor ID
- 307300
- Conditions
- Wheezing, Respiratory Sounds
- Keywords
- Preschool Wheeze, Asthma Attack
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Engineering and Physical Sciences Research Council, UK
- Study start
- Aug 2022 (estimated)
- Primary completion
- 29 Nov 2023 (estimated)
- Study completion
- 29 Mar 2024 (estimated)
- First posted
- 7 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.
The aim of this project is to fill the significant unmet healthcare need to prevent wheeze attacks in preschool children. This will be achieved by developing a proof-of-concept, bespoke home remote objective monitoring system for preschool children that can identify early signs before a wheeze attack to allow early intervention and prevention. This study aims to develop methods for recognising child-specific abnormal patterns in time-course lung function data, and wheeze onset providing early warning of deterioration. The prototype system is targeted for use by caregivers of preschool children with wheeze, and will integrate the individual child's information about symptoms, medication use and lung function to alert parents to seek healthcare advice to prevent hospitalisation.
Detailed description
Asthma is the most common childhood non-infectious lung disease in the United Kingdom, affecting ~8% of children. Asthma symptoms include wheezing (a high-pitched whistling sound created by turbulent airflow through narrowed airways) associated with difficulty in breathing and shortness of breath, often with a dry cough. Asthma is characterised by episodic (wheeze attacks) and variable symptoms which fluctuate day-to-day. An asthma, or wheeze attack, is a sudden worsening of symptoms, associated with airway obstruction that requires treatment to open up the airways.
Preschool children (aged 1-5 years) account for the majority (75%) of hospital admissions for acute attacks of wheezing in the UK. Up to half of all preschool children will suffer at least one episode of wheezing by their 6th birthday, and 7.8% of preschool children came to primary care with acute wheezing in 2017 in the UK. Frequent severe wheeze attacks in preschool age are the strongest risk factor for diminished lung function at physiological peak in early adulthood and are associated with chronic obstructive pulmonary disease (COPD) in the sixth decade of life, as well as early all-cause mortality and cardiovascular and metabolic comorbidities. It is therefore vital to prevent wheeze attacks in preschool children.
Preschool children experience a 5-times higher rate of hospitalisation for acute wheeze attacks compared to school-aged children. This suggests overt symptoms present late, and not soon enough, for early intervention to prevent attacks in preschool children. The number of unscheduled healthcare presentations of acute wheeze attacks has not decreased for the last 2 decades for preschool children, while it has been declining for school-aged children and adults, resulting in a high socioeconomic burden in the UK and worldwide.
Failure to prevent wheeze attacks in preschool children is in part due to the absence of age-specific remote and objective monitoring technology for disease severity. Currently, in this age group, symptoms are diagnosed and monitored by subjective assessments of airway obstruction (narrowing). Evidence that the symptoms improve following treatment with inhaled bronchodilators is used as an indirect indication of the presence of reversible airway obstruction, which is a cardinal feature of asthma. In school-aged children and adults, airway obstruction is monitored objectively with lung function tests such as spirometry. Spirometry can be performed remotely at home to aid telemedicine monitoring in asthma. However, spirometry requires a forced expiratory manoeuvre and cooperation from the patient. It can thus only be reliably performed in children over 5 years old. As a result, diagnosis and monitoring of wheezing/asthma in preschool children depends on parental reports, clinical examination and subjective assessment of symptoms, but no objective measures of airway obstruction.
For this study, time-course lung function data will be obtained using a novel home-based wearable device designed for preschool children that detects airway obstruction whilst the child is asleep (Ventica®). Also, eliciting objective confirmation of wheeze will be obtained by the use of the WheezeScan® device, which detects presence/absence of wheeze when placed on the child's chest. This information will contribute to developing an app that combines symptoms, medication use, and lung function to allow wheeze detection and provide a personalised plan for parents to seek healthcare advice.
STUDY HYPOTHESES
- A mobile-based system integrating data on remote lung function, symptoms and medication use can be used to predict the development of an acute attack of wheeze in children aged 1-5 years.
- The dynamic change in lung function reflects underlying airway pathology in severe wheezing
STUDY OBJECTIVES
- To develop a mobile app system that collects data on lung function, symptoms and medication use, and returns personalised prediction for preschool wheezers, empowering parents to self-manage their child's wheeze/asthma.
- To quantify airway inflammation and remodelling in endobronchial biopsies and broncho-alveolar lavage from a subgroup of preschool children with severe wheezing and relate pathology to the pattern of airway obstruction detected using the Ventica® system.
- To develop prediction models that integrate patient-specific abnormal patterns in time-course lung function data, symptoms recorded using with and without WheezeScan®, and rescue medication use, providing early warning of deterioration.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1/Children aged between 1-5 years from the emergency department | – | Device: Lung function monitoring equipment at home - 2 weeksChildren who have attended the emergency department at St Mary's Hospital, with an acute attack of wheezing. These families will be asked to use the lung function monitoring and the wheeze detection device every night for 2 weeks, while recording symptoms and medication use in the last 24 hours. |
| 2/Children aged between 1-5 years admitted electively for wheezing investigation | – | Device: Lung function monitoring equipment at home - 4 months, Diagnostic Test: Inflammation and remodelling from clinical indicted bronchoscopyChildren who have been admitted electively for investigations of their wheezing at the Brompton Hospital. These children/families will be asked to do the lung function monitoring and the wheeze detection device once per week for 4 months, while recording symptoms and medication use in the last 24 hours. |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 1-5 years with recurrent wheezing selected from the hospital emergency department and electively investigations.
Key inclusion criteria (4 listed)
- Children aged 1-5 years
- Doctor diagnosed and confirmed wheeze
- At least one previous attack of wheeze in the previous year
- Parents/carers with access to a smart phone or computer (to allow data to be entered into the online questionnaire)
Key exclusion criteria (4 listed)
- Prematurity < 34 weeks gestation
- Need for ventilation in the first seven days after birth
- Known cardiac disease
- Known diagnosis of another respiratory condition (e.g. cystic fibrosis, bronchiectasis)
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 |
|---|---|---|
| Lung function monitoring equipment at home - 2 weeksThe parent/carer setup the lung function monitoring equipment (Ventica®), and placed the WheezeScan® device on the child's chest at home before the child goes to sleep. This is performed once daily for 2 weeks. | Device | 1/Children aged between 1-5 years from the emergency department |
| Lung function monitoring equipment at home - 4 monthsThe parent/carer setup the lung function monitoring equipment (Ventica®), and placed the WheezeScan® device on the child's chest at home before the child goes to sleep. This is performed once weekly for 4 months. | Device | 2/Children aged between 1-5 years admitted electively for wheezing investigation |
| Inflammation and remodelling from clinical indicted bronchoscopyFor patients who are undergoing clinically indicated bronchoscopy, consent will be obtained to use any surplus clinical samples for this study. The samples to be collected are broncho-alveolar lavage and endobronchial biopsies. Both of these are taken from the airways during clinical bronchoscopy. | Diagnostic test | 2/Children aged between 1-5 years admitted electively for wheezing investigation |
Primary outcome
Relation of lung function to symptoms and medication use (Group 1)
Time frame: 2 weeks
The lung function measured with the Ventica® system measures tidal breathing variability (non-invasive) in order to assist with the diagnosis and monitoring of asthma or asthmatic symptoms in children aged five years and under. It includes 4 electrodes that are placed under the child's arms - with wires that connect to a small recorder, which is included in a vest that is worn overnight. The presence of wheeze would be detected with the WheezeScan® device, this device needs to be placed on the child's chest for 30-60 seconds and it will confirm if wheezing is present. This will be used by families either when they think their child has symptoms or routinely just prior to the lung function monitoring equipment being used. Both devices include European Conformity (CE) certification and are available for purchase commercially. Symptoms and medication use will be collected using an online secure questionnaire that will be accessible from a computer or a mobile phone.
Relation of lung function to symptoms and medication use (Group 2)
Time frame: 4 months
The lung function measured with the Ventica® system measures tidal breathing variability (non-invasive) in order to assist with the diagnosis and monitoring of asthma or asthmatic symptoms in children aged five years and under. It includes 4 electrodes that are placed under the child's arms - with wires that connect to a small recorder, which is included in a vest that is worn overnight. The presence of wheeze would be detected with the WheezeScan® device, this device needs to be placed on the child's chest for 30-60 seconds and it will confirm if wheezing is present. This will be used by families either when they think their child has symptoms or routinely just prior to the lung function monitoring equipment being used. Both devices include European Conformity (CE) certification and are available for purchase commercially. Symptoms and medication use will be collected using an online secure questionnaire that will be accessible from a computer or a mobile phone.
Relation of lung function to airway pathology (Group 2)
Time frame: 4 months
Information of patients having a planned bronchoscopy will be collected, to relate airway inflammation and remodelling in bronchial biopsies and broncho-alveolar lavage to the pattern of airway obstruction detected using the Ventica® lung function monitoring system. The endobronchial biopsies will quantify the changes that may cause a child to have wheezing, this includes the amount of mucus, smooth muscle and collagen in the biopsy. The results from these analyses will be related to the lung function measurements, to assess whether specific types of changes in the airway samples relate to specific types of changes in lung function.
Develop a prototype app that combine symptoms, medication use and lung function
Time frame: 4 months
The mobile app system will collect data on lung function, symptoms and medication use, and will return personalised predictions for preschool wheezers. The prediction model of attacks and loss of symptom control will be trained using the longitudinal data obtained from the children in the study. Change in lung function, and time to normalisation following treatment for wheezing, will be assessed to understand the time taken for full recovery, and whether persistently abnormal lung function, without overt symptoms, may be an early and sensitive sign for a future attack. The relative contributions of each parameter (symptoms, medication use, wheeze detection, lung function, lower airway inflammation) in determining the accuracy of the model will be assessed to determine the added value of lung function monitoring in predicting individualised patterns of loss of control.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Karina Mayoral, MPH contact
Sejal Saglani, MD principal investigator
Imperial College London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wheezing and Respiratory Sounds, run by Imperial College London at 2 sites 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sejal Saglani, MD (+442075943167, s.saglani@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relation of lung function to symptoms and medication use (Group 1) (time frame: 2 weeks). 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?
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 7 Jul 2022.