Chronic Obstructive Pulmonary DiseaseICENCT00981851
Interaction in Chronic Obstructive Pulmonary Disease Experiment
A study testing Tiotropium (Spiriva) + Salbutamol (Ventolin) in people with Chronic Obstructive Pulmonary Disease and Cardiovascular Disease, run by Radboud University Medical Center at 2 sites in Netherlands.
Trial summary
The final purpose of this study is to determine whether bronchodilation and cigarette smoking in Chronic Obstructive Pulmonary Disease (COPD) patients interact, resulting in an increase of cardiovascular disease. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Cardiovascular Disease, Smoking
- What is being tested?
- Tiotropium (Spiriva) + Salbutamol (Ventolin)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesNetherlands
- Study dates
- Sep 2009to May 2011
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD Gold stage II-III (FEV1/FVC<0,70 and FEV1 30-80% of predicted value).
- Current cigarette smoking (at the time of performing the study).
- Willing to provide written informed consent.
- Refrain from smoking and bronchodilators > 8 hours (depends on treatment) before the test.
- Registered in one of the recruitment institutes.
Who cannot join
- COPD gold stage I or IV.
- Asthmatic component: History of asthma, present asthma by complaints, eosinophilia or reversibility ≥ 10% of predicted.
- Unable to communicate.
- Physically unable to perform any of the tests.
- Non-COPD respiratory disorders.
- Previous lung-volume reduction surgery and/or lung transplantation.
- Evidence of alcohol, drug or solvent abuse.
- Known α-1 antitrypsin deficiency.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
University Center for Chronic Diseases Dekkerswald
Groesbeek
Primary care, general practitioners
Nijmegen
About this study
Official title: A Hazardous Combination of Cigarette Smoking and Bronchodilation in Chronic Obstructive Pulmonary Disease
The final purpose of this study is to determine whether bronchodilation and cigarette smoking in Chronic Obstructive Pulmonary Disease (COPD) patients interact, resulting in an increase of cardiovascular disease. The aim of this part of the study is to demonstrate the basic mechanism: Does increased respiratory function after administration of a bronchodilator in patients with COPD lead to elevated pulmonary retention of the harmful compounds in inhaled cigarette smoke and to short-term biological effects associated with cardiovascular disease?
Read the detailed description
COPD currently is one of the most frequent diseases. In more than 80% of COPD patients, the disease is caused by smoking. About half of the COPD patients are active smokers, although smoking is also the most important prognostic factor. Also, smoking is an important cause as well as an important prognostic factor in cardiovascular disease. The corner stone of medical treatment in COPD is bronchodilation; more than half of the patients use a long-acting bronchodilator. An increase of the pathogenic effect of smoking by an increased lung function after bronchodilation is likely though, since more pathogenic particles would penetrate the lung. We hypothesize that bronchodilators increase cardiovascular disease in COPD patients who smoke.
In order to demonstrate the basic mechanism of our hypothesis, COPD patients receive a bronchodilator at one time and a placebo at another time, preceded and followed by cigarette smoking during one hour as by a strict time schedule. Smoke retention, lung function and blood biomarkers are repeatedly measured.
- Being tested
- Tiotropium (Spiriva) + Salbutamol (Ventolin), placebo
- Keywords
- intervention study, interaction, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cardiovascular Diseases, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tiotropium (Spiriva) + Salbutamol (Ventolin)Drug
Also called Spiriva Respimat, Ventolin Aerosol
1 time inhalation of 5 mcg of Tiotropium bromide by Respimat and 400 mcg of Salbutamol by Volume Spacer. cigarette smoking
placeboDrug
Also called Ventolin placebo and Spiriva placebo
1 time inhalation of placebo with the amount of puffs similar to the active comparator. cigarette smoking
| Study group | Role | What they receive |
|---|---|---|
| beta 2 agonist + anticholinergic aerosol | Active comparator | Not described Receives: Drug: Tiotropium (Spiriva) + Salbutamol (Ventolin) |
| placebo inhalation | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
cigarette smoke retention
Measured: retention measurement is during smoking. smoking is 1 cigarette before and 1 cigarette 45 minutes after medication inhalation for each arm. 1 week between arms
Secondary outcomes (4)
(hs)CRP
Measured: 3 times within 2 hours for each arm
fibrinogen
Measured: 3 times within 2 hours for each arm
respiratory function
Measured: at baseline and repeatedly around medication inhalation for 1.5 hours
smoking pattern: smoke inhalation and smoke exhalation time and volume
Measured: during smoking cigarettes: twice for each arm.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Tjard RJ Schermer, PhD, Principal investigator, Radboud University Nijmegen Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981851
- Sponsor's protocol ID
- RvB08.066.51196/GE
- Acronym
- ICE
- Status last verified
- Oct 2009
- First submitted
- 21 Sep 2009
- Last updated
- 6 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
van Dijk WD, Heijdra Y, Lenders JW, Klerx W, Akkermans R, van der Pouw A, van Weel C, Scheepers PT, Schermer TR. Cigarette smoke retention and bronchodilation in patients with COPD. A controlled randomized trial. Respir Med. 2013 Jan;107(1):112-9. doi: 10.1016/j.rmed.2012.09.019. Epub 2012 Oct 12.
PubMed 23069326van Dijk WD, Scheepers PT, Cremers R, Lenders JW, Klerx W, van Weel C, Schermer TR, Heijdra Y. A method to study the effect of bronchodilators on smoke retention in COPD patients: study protocol for a randomized controlled trial. Trials. 2011 Feb 10;12:37. doi: 10.1186/1745-6215-12-37.
PubMed 21310040
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Hazardous Combination of Cigarette Smoking and Bronchodilation in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT00981851
- Acronym / sponsor ID
- ICE / RvB08.066.51196/GE
- Keywords
- intervention study, interaction, COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 22 Sep 2009 (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.
The final purpose of this study is to determine whether bronchodilation and cigarette smoking in Chronic Obstructive Pulmonary Disease (COPD) patients interact, resulting in an increase of cardiovascular disease. The aim of this part of the study is to demonstrate the basic mechanism: Does increased respiratory function after administration of a bronchodilator in patients with COPD lead to elevated pulmonary retention of the harmful compounds in inhaled cigarette smoke and to short-term biological effects associated with cardiovascular disease?
Detailed description
COPD currently is one of the most frequent diseases. In more than 80% of COPD patients, the disease is caused by smoking. About half of the COPD patients are active smokers, although smoking is also the most important prognostic factor. Also, smoking is an important cause as well as an important prognostic factor in cardiovascular disease. The corner stone of medical treatment in COPD is bronchodilation; more than half of the patients use a long-acting bronchodilator. An increase of the pathogenic effect of smoking by an increased lung function after bronchodilation is likely though, since more pathogenic particles would penetrate the lung. We hypothesize that bronchodilators increase cardiovascular disease in COPD patients who smoke.
In order to demonstrate the basic mechanism of our hypothesis, COPD patients receive a bronchodilator at one time and a placebo at another time, preceded and followed by cigarette smoking during one hour as by a strict time schedule. Smoke retention, lung function and blood biomarkers are repeatedly measured.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| beta 2 agonist + anticholinergic aerosol | Active comparator | Drug: Tiotropium (Spiriva) + Salbutamol (Ventolin) |
| placebo inhalation | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- COPD Gold stage II-III (FEV1/FVC<0,70 and FEV1 30-80% of predicted value).
- Current cigarette smoking (at the time of performing the study).
- Willing to provide written informed consent.
- Refrain from smoking and bronchodilators > 8 hours (depends on treatment) before the test.
- Registered in one of the recruitment institutes.
Key exclusion criteria (8 listed)
- COPD gold stage I or IV.
- Asthmatic component: History of asthma, present asthma by complaints, eosinophilia or reversibility ≥ 10% of predicted.
- Unable to communicate.
- Physically unable to perform any of the tests.
- Non-COPD respiratory disorders.
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 |
|---|---|---|
| Tiotropium (Spiriva) + Salbutamol (Ventolin)Also: Spiriva Respimat, Ventolin Aerosol1 time inhalation of 5 mcg of Tiotropium bromide by Respimat and 400 mcg of Salbutamol by Volume Spacer. cigarette smoking | Drug | beta 2 agonist + anticholinergic aerosol |
| placeboAlso: Ventolin placebo and Spiriva placebo1 time inhalation of placebo with the amount of puffs similar to the active comparator. cigarette smoking | Drug | placebo inhalation |
Primary outcome
cigarette smoke retention
Time frame: retention measurement is during smoking. smoking is 1 cigarette before and 1 cigarette 45 minutes after medication inhalation for each arm. 1 week between arms
4 secondary outcomes
(hs)CRP
Time frame: 3 times within 2 hours for each arm
fibrinogen
Time frame: 3 times within 2 hours for each arm
respiratory function
Time frame: at baseline and repeatedly around medication inhalation for 1.5 hours
smoking pattern: smoke inhalation and smoke exhalation time and volume
Time frame: during smoking cigarettes: twice for each arm.
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 6 Jul 2011.
- Derived from this study: PubMed 23069326van Dijk WD, Heijdra Y, Lenders JW, Klerx W, Akkermans R, van der Pouw A, van Weel C, Scheepers PT, Schermer TR. Cigarette smoke retention and bronchodilation in patients with COPD. A controlled randomized trial. Respir Med. 2013 Jan;107(1):112-9. doi: 10.1016/j.rmed.2012.09.019. Epub 2012 Oct 12.
- Derived from this study: PubMed 21310040van Dijk WD, Scheepers PT, Cremers R, Lenders JW, Klerx W, van Weel C, Schermer TR, Heijdra Y. A method to study the effect of bronchodilators on smoke retention in COPD patients: study protocol for a randomized controlled trial. Trials. 2011 Feb 10;12:37. doi: 10.1186/1745-6215-12-37.
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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.
Tjard RJ Schermer, PhD principal investigator
Radboud University Nijmegen Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tiotropium (Spiriva) + Salbutamol (Ventolin) in people with Chronic Obstructive Pulmonary Disease and Cardiovascular Disease, run by Radboud University Medical Center at 2 sites in Netherlands.
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 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 6 Jul 2011. 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 Netherlands. 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 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?
cigarette smoke retention (time frame: retention measurement is during smoking. smoking is 1 cigarette before and 1 cigarette 45 minutes after medication inhalation for each arm. 1 week between arms). 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 NCT00981851, which also lists 2 linked publications.
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 6 Jul 2011.