Chronic Obstructive Pulmonary DiseaseNCT00180843
Assessment of Ventilation-perfusion Abnormalities in Patients With Stable Smoking-related Airways Disease
A study testing salbutamol + ipratropium bromide nebules and nebulized saline in people with Chronic Obstructive Pulmonary Disease, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Subjects undergo history, examination, lung function assessment after informed consent has been obtained. All subjects will undergo ventilation-perfusion scans. If there first scan is normal they will undergo a second and final scan four weeks later. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- salbutamol + ipratropium bromide nebules and nebulized saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2005to Feb 2008
- Phase
- Interventional
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- FEV1 < 70% predicted at baseline on spirometry
- significant smoking history or alpha 1 antitrypsin deficiency
- no evidence of current infection or restrictive lung disease
Who cannot join
- history of other significant respiratory disease
- significant respiratory infection within 6 weeks
- history of significant physical or mental illness rendering them unfit for the study in the opinion of the investigator
- taken part in any other research within the past 12 months, or received exposure to ionizing radiation
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College Hammersmith Campus
London, London, W12 0HS
About this study
Official title: Assessment of Ventilation-perfusion Abnormalities in Patients With Smoking-related Airways Disease in Stable Condition and the Effect of Bronchodilator Therapy
Subjects undergo history, examination, lung function assessment after informed consent has been obtained. All subjects will undergo ventilation-perfusion scans. If there first scan is normal they will undergo a second and final scan four weeks later. If abnormal they will undergo two further scans with either nebulized bronchodilator or nebulized saline prior to their second and third scans. Each time they will have repeat lung function tests prior to scanning. We will examine the regional changes in ventilation and perfusion and there relationship to lung function.
Read the detailed description
As in Brief description
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- salbutamol + ipratropium bromide nebules, nebulized saline
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salbutamol + ipratropium bromide nebulesDrug
Also called albuterol, Ventolin, Atrovent
nebulized salineDrug
| Study group | Role | What they receive |
|---|---|---|
| saline control | Placebo comparator | nebulized saline Receives: Drug: nebulized saline |
| salbutamol and ipratropium bromide nebules | Active comparator | salbutamol 2.5 mg and ipratropium bromide 0.5 mg Receives: Drug: salbutamol + ipratropium bromide nebules |
What is being measured
The primary outcome is the main question the study is designed to answer.
scan grade
previously validated grading score
Measured: post scan
Secondary outcomes (1)
lung function
Measured: pre scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionFeb 2008
- Study completionFeb 2008
Why it stopped: lack of resources research fellow left
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Philip Ind, Imperial College London
- Investigators
- Philip W Ind, MB BChir MRCP, Principal investigator, Imperial College Hammersmith
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00180843
- Sponsor's protocol ID
- 04/6741
- Status last verified
- Sep 2013
- First submitted
- 13 Sep 2005
- Last updated
- 24 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Ventilation-perfusion Abnormalities in Patients With Smoking-related Airways Disease in Stable Condition and the Effect of Bronchodilator Therapy
- ClinicalTrials.gov ID
- NCT00180843
- Acronym / sponsor ID
- 04/6741
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of resources research fellow left
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Sep 2005
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 16 Sep 2005 (estimated)
- 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.
Subjects undergo history, examination, lung function assessment after informed consent has been obtained. All subjects will undergo ventilation-perfusion scans. If there first scan is normal they will undergo a second and final scan four weeks later. If abnormal they will undergo two further scans with either nebulized bronchodilator or nebulized saline prior to their second and third scans. Each time they will have repeat lung function tests prior to scanning. We will examine the regional changes in ventilation and perfusion and there relationship to lung function.
Detailed description
As in Brief description
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| saline control | Placebo comparator | Drug: nebulized salinenebulized saline |
| salbutamol and ipratropium bromide nebules | Active comparator | Drug: salbutamol + ipratropium bromide nebulessalbutamol 2.5 mg and ipratropium bromide 0.5 mg |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- FEV1 < 70% predicted at baseline on spirometry
- significant smoking history or alpha 1 antitrypsin deficiency
- no evidence of current infection or restrictive lung disease
Key exclusion criteria (4 listed)
- history of other significant respiratory disease
- significant respiratory infection within 6 weeks
- history of significant physical or mental illness rendering them unfit for the study in the opinion of the investigator
- taken part in any other research within the past 12 months, or received exposure to ionizing radiation
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 |
|---|---|---|
| salbutamol + ipratropium bromide nebulesAlso: albuterol, Ventolin, Atrovent | Drug | salbutamol and ipratropium bromide nebules |
| nebulized saline | Drug | saline control |
Primary outcome
scan grade
Time frame: post scan
previously validated grading score
1 secondary outcome
lung function
Time frame: pre scan
Results and safety
The study was stopped early (reason given: lack of resources research fellow left). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2013.
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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.
Philip W Ind, MB BChir MRCP principal investigator
Imperial College Hammersmith
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing salbutamol + ipratropium bromide nebules and nebulized saline in people with Chronic Obstructive Pulmonary Disease, 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 3 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: stopped early, as of the sponsor's last update on 24 Sep 2013. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: lack of resources research fellow left). Results are not available in the source record.
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?
scan grade (time frame: post scan). 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 24 Sep 2013.