AsthmaNCT00677560
The Natural History of Small Airways Physiology in Diseased and Healthy States
An observational study of Asthma and COPD, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Spirometry is a useful clinical tool for the assessment and monitoring of lung disease, however, it does not provide information on peripheral airways resistance. On the contrary, impulse oscillometry (IOS) may provide information not only on airway resistance (Rrs) but also on the elastic properties of the lung… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, COPD, Interstitial Lung Disease
- How many people
- 126 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Jun 2010to 10 Jul 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients will be recruited from outpatient clinics
Who may be able to join
- male or female, aged between 18-85 years;
- volunteers who are able to give written informed consent Patients meeting the diagnostic criteria for asthma, COPD, ILD, CF, chronic cough.
Who cannot join
- upper respiratory tract infection within the previous 28 days
- any history or evidence of renal, cardiovascular, gastrointestinal or hepatic disease
- any history and evidence of neuropsychiatric disease
- treatment with antibiotics within 4 weeks prior to the study
- alcohol, drug abuse or any other condition associated with poor compliance
- breast feeding
- pregnancy
- are unable to provide written informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Airway Disease Section, National Heart and Lung Institute, Imperial College
London, SW3 6LY
About this study
Official title: Impulse Oscillometry and Airway Inflammation in Asthma and Chronic Obstructive Pulmonary Disease and Airways Physiology in Other Lung Conditions and Healthy Lungs
Spirometry is a useful clinical tool for the assessment and monitoring of lung disease, however, it does not provide information on peripheral airways resistance. On the contrary, impulse oscillometry (IOS) may provide information not only on airway resistance (Rrs) but also on the elastic properties of the lung (Xrs). In addition, multiple breath nitrogen washout (MBNW) utilizes the exhalation of nitrogen gas from the airways to determine changes in lung ventilation and derive small airways indices (that tells us about small airways calibre). This method, like IOS, allows a precise assessment of small airways function.
Even though patients with asthma may show some reduction of the caliber of the small airways these changes are more a feature of patients with COPD. The study team hypothesize that IOS and MBNW measurements may detect these differences and provide different resistance profiles for asthma and COPD. Furthermore, the study team would like to investigate the relationship between airway inflammation and small airway disease by measuring exhaled nitric oxide (NO) at multiple exhalation flow rates. This technique allows the partitioning of NO produced in the central airways from that generated more peripherally in the lung, providing valuable information on the activity of inflammation in different parts of the respiratory system. The study team hope that the combined use of IOS, MBNW and NO will identify a possible correlation between inflammation and small airway dysfunction.
Read the detailed description
Background
The main objective of this study is to measure the damage of the small airways in lung disease exploring the "silent zone" with methods that have not been used before together in the same patients. Furthermore, because this is a 4 year longitudinal study, the study team will investigate the time related changes of small airway function in lung disease and normal healthy subjects.
The study will also investigate the relationship between small airway resistance and inflammation.
- Conditions
- Asthma, COPD, Interstitial Lung Disease, Cystic Fibrosis, Patients Requiring Lung Transplant
- Keywords
- resistance, reactance, inflammation, lung function, respiratory function
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial, Cystic Fibrosis, Inflammation, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 3 | Mild-moderate asthma. Within the asthma group, there were two sub-groups; mild-moderate asthma and severe asthma distinguished using the Global Initiative for Asthma (GINA) guidelines (GINA, 2009). | |
| 4 | Severe Asthma Within the asthma group, there were two sub-groups; mild-moderate asthma and severe asthma distinguished using the Global Initiative for Asthma (GINA) guidelines (GINA, 2009). | |
| 1 | Normal subjects Normal subjects were a group made up of healthy subjects, with normal lung function, non-smokers at the time of the screening. | |
| 2 | Healthy smokers Healthy smokers were comprised of people who were current smokers and had normal lung function at the time of screening. | |
| 5 | COPD (Gold stage I - III) The COPD group included stage I to III patients, classified according to severity of airflow limitation (post bronchodilator FEV1), from the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (GOLD, 2011). |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1
Forced expiratory volume in one second
Measured: 120 minutes
Secondary outcomes (6)
Calv
Nitric oxide arising from the alveolar compartment.
Measured: 120 minutes
AX
Reactance area for whole-breath
Measured: 120 minutes
R5 EX
Resistance measured at 5 hertz during expiration
Measured: 120 minutes
J'aw
Bronchial nitric oxide flux
Measured: 120 minutes
Sacin
Ventilation heterogeneity within the acinar airways
Measured: 120 minutes
Scond
Ventilation heterogeneity within the conducting airways
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2008 (estimated)
- Study start22 Jun 2010
- Primary completion10 Jul 2013
- Study completion10 Jul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies 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
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paolo Paredi, MD, PhD, Study director, Airway Disease Section, National Heart and Lung Institute, Imperial College, LondonOmar A Usmani, MD, PhD, Principal investigator, Airway Disease Section, National Heart and Lung Institute, Imperial College, LondonPeter J Barnes, Prof, Study chair, Airway Disease Section, National Heart and Lung Institute, Imperial College, LondonNeil Pride, Prof, Study chair, Airway Disease Section, National Heart and Lung Institute, Imperial College, LondonMichael Goldman, Prof, Study chair, Airway Disease Section, National Heart and Lung Institute, Imperial College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677560
- Sponsor's protocol ID
- 08/H0709/2
- Status last verified
- Nov 2021
- First submitted
- 12 May 2008
- Last updated
- 20 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impulse Oscillometry and Airway Inflammation in Asthma and Chronic Obstructive Pulmonary Disease and Airways Physiology in Other Lung Conditions and Healthy Lungs
- ClinicalTrials.gov ID
- NCT00677560
- Acronym / sponsor ID
- 08/H0709/2
- Conditions
- Asthma, COPD, Interstitial Lung Disease, Cystic Fibrosis, Patients Requiring Lung Transplant
- Keywords
- resistance, reactance, inflammation, lung function, respiratory function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 22 Jun 2010 (actual)
- Primary completion
- 10 Jul 2013 (actual)
- Study completion
- 10 Jul 2013 (actual)
- First posted
- 14 May 2008 (estimated)
- Results
- Posted 20 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Spirometry is a useful clinical tool for the assessment and monitoring of lung disease, however, it does not provide information on peripheral airways resistance. On the contrary, impulse oscillometry (IOS) may provide information not only on airway resistance (Rrs) but also on the elastic properties of the lung (Xrs). In addition, multiple breath nitrogen washout (MBNW) utilizes the exhalation of nitrogen gas from the airways to determine changes in lung ventilation and derive small airways indices (that tells us about small airways calibre). This method, like IOS, allows a precise assessment of small airways function.
Even though patients with asthma may show some reduction of the caliber of the small airways these changes are more a feature of patients with COPD. The study team hypothesize that IOS and MBNW measurements may detect these differences and provide different resistance profiles for asthma and COPD. Furthermore, the study team would like to investigate the relationship between airway inflammation and small airway disease by measuring exhaled nitric oxide (NO) at multiple exhalation flow rates. This technique allows the partitioning of NO produced in the central airways from that generated more peripherally in the lung, providing valuable information on the activity of inflammation in different parts of the respiratory system. The study team hope that the combined use of IOS, MBNW and NO will identify a possible correlation between inflammation and small airway dysfunction.
Detailed description
Background
The main objective of this study is to measure the damage of the small airways in lung disease exploring the "silent zone" with methods that have not been used before together in the same patients. Furthermore, because this is a 4 year longitudinal study, the study team will investigate the time related changes of small airway function in lung disease and normal healthy subjects.
The study will also investigate the relationship between small airway resistance and inflammation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 3 | – | –Mild-moderate asthma. Within the asthma group, there were two sub-groups; mild-moderate asthma and severe asthma distinguished using the Global Initiative for Asthma (GINA) guidelines (GINA, 2009). |
| 4 | – | –Severe Asthma Within the asthma group, there were two sub-groups; mild-moderate asthma and severe asthma distinguished using the Global Initiative for Asthma (GINA) guidelines (GINA, 2009). |
| 1 | – | –Normal subjects Normal subjects were a group made up of healthy subjects, with normal lung function, non-smokers at the time of the screening. |
| 2 | – | –Healthy smokers Healthy smokers were comprised of people who were current smokers and had normal lung function at the time of screening. |
| 5 | – | –COPD (Gold stage I - III) The COPD group included stage I to III patients, classified according to severity of airflow limitation (post bronchodilator FEV1), from the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (GOLD, 2011). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients will be recruited from outpatient clinics
Key inclusion criteria (2 listed)
- male or female, aged between 18-85 years;
- volunteers who are able to give written informed consent Patients meeting the diagnostic criteria for asthma, COPD, ILD, CF, chronic cough.
Key exclusion criteria (8 listed)
- upper respiratory tract infection within the previous 28 days
- any history or evidence of renal, cardiovascular, gastrointestinal or hepatic disease
- any history and evidence of neuropsychiatric disease
- treatment with antibiotics within 4 weeks prior to the study
- alcohol, drug abuse or any other condition associated with poor compliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
FEV1
Time frame: 120 minutes
Forced expiratory volume in one second
6 secondary outcomes
Calv
Time frame: 120 minutes
AX
Time frame: 120 minutes
R5 EX
Time frame: 120 minutes
J'aw
Time frame: 120 minutes
Sacin
Time frame: 120 minutes
Scond
Time frame: 120 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Paolo Paredi, MD, PhD study director
Airway Disease Section, National Heart and Lung Institute, Imperial College, London
Omar A Usmani, MD, PhD principal investigator
Airway Disease Section, National Heart and Lung Institute, Imperial College, London
Peter J Barnes, Prof study chair
Airway Disease Section, National Heart and Lung Institute, Imperial College, London
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 Asthma and COPD, run by Imperial College London 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 2 inclusion and 8 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 20 Dec 2021. 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?
Yes. Results are posted in the registry (first posted 20 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
FEV1 (time frame: 120 minutes). 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 20 Dec 2021.