COPDPhase 4NCT00911651
Study to Assess the Effect of Salbutamol and Ipratropium Bromide in Chronic Obstructive Pulmonary Disease (COPD) Patients
A Phase 4 study testing Salbutamol and ipratropium bromide in people with COPD, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
The objectives of this study are to assess the effect of salbutamol in comparison with ipratropium bromide on the geometry of central and peripheral airways and to correlate spirometric indices with the Computational Fluid Dynamics (CFD) based calculated airway volumes and resistances for both compounds. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- COPD
- What is being tested?
- Salbutamol and ipratropium bromide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2008to Aug 2008
- Phase
- Phase 4
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with documented COPD based on the following criteria:
- Smoking history of at least 10 pack-years.
- Decreased Tiffeneau index (FEV1/(F)VC < 0.70).
- Patients aged ≥ 40 years.
- Patients should present moderate to severe COPD with an FEV1 between 30 and 80% of predicted (GOLD 2 and 3).
- Patients should be treated according to GOLD guidelines.
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- Able to inhale study drug.
- Maintained on stable respiratory medications for 6 weeks prior to visit 1.
- Able to perform lung function tests.
- Able to follow study procedures.
Who cannot join
- Patients who are allergic to salbutamol, ipratropium bromide or to another element of the product.
- Patients allergic to sojalecithin and products on the basis of soja and peanut.
- Patients who have or ever had glaucoma.
- Patients with urinary problems, prostate hyperplasy or bladder-neck obstruction. Patients whose symptoms are controlled on treatment may be included.
- Patients with a recent history (i.e. six months or less) of myocardial infarction.
- Patients with any unstable or life threatening cardiac arrhythmia.
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- Patients with severe kidney insufficiency (creatinine clearance ≤50 ml/min)a.
- Patients below the age of 40.
- Patients who are pregnant or are breast-feeding.
- Patients who are treated with other anticholinergic medications, that cannot be stopped during the study period.
- A respiratory infection or exacerbation of COPD in the four weeks prior to screening.
- Significant alcohol or drug abuse within the past 12 months.
- Participation in another trial with an investigational drug within one month or six half lives (whichever is greater) prior to screening visit.
- Known active tuberculosis.
- A history of asthma, cystic fibrosis, central bronchiectasis, interstitial lung disease or pulmonary thromboembolic disease.
- A history of thoracotomy with pulmonary resection.
- Active or untreated malignancy.
- Use of oral corticosteroid medication at unstable doses (i.e. less than six weeks on a stable dose) or at doses ≥ 10 mg/day.
- a Cockroft's formulae should be applied: in male: creatinine clearance = (140-age) x weight / 72 x creatininemia in female: creatinine clearance = 0.85 x (140-age) x weight / 72 x creatininemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open, Randomized, Two-Way Crossover, Pilot Study to Assess the Effect of Salbutamol in Comparison With Ipratropium Bromide on Central and Peripheral Airway Dimensions in COPD Patients
The objectives of this study are to assess the effect of salbutamol in comparison with ipratropium bromide on the geometry of central and peripheral airways and to correlate spirometric indices with the Computational Fluid Dynamics (CFD) based calculated airway volumes and resistances for both compounds.
Read the detailed description
Salbutamol (VentolinTM) is a short acting beta agonist (SABA) which is used to treat wheezing, dyspnea and breathing difficulties caused by asthma and COPD. Further, it is also used to prevent bronchospasm during exercise.
Ipratropium bromide (Atrovent® HFA) is a short acting anticholinergic bronchodilator (short acting muscarinic antagonist (SAMA)) that improves lung function, dyspnea, exercise tolerance and health-related quality of life in patients with COPD. Studies have also shown that ipratropium bromide might reduce COPD exacerbations and related hospitalisations because the extended bronchodilatation might reduce infection rates by improving clearance of respiratory secretions.
In this open, randomized, two-way crossover, pilot study the effect of salbutamol in patients with moderate and severe COPD will be examined in comparison with the effects of ipratropium bromide. These patients will receive 400 µg salbutamol and 80 µg ipratropium bromide in a randomized crossover design.
The objectives of this study are to assess the effect of salbutamol in comparison with ipratropium bromide on the geometry of central and peripheral airways and to correlate spirometric indices (as Forced Expiratory Volume in one second (FEV1) and Tiffeneau index) with the Computational Fluid Dynamics (CFD) based calculated airway volumes and resistances for both compounds.
- Conditions
- COPD
- Being tested
- Salbutamol, ipratropium bromide
- Keywords
- COPD, salbutamol, ipratropium bromide, computational fluid dynamics, functional imaging, central and peripheral airways
- 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.
SalbutamolDrug
Also called Ventolin
400 µg inhalation once
ipratropium bromideDrug
Also called atrovent
80 µg inhalation once
| Study group | Role | What they receive |
|---|---|---|
| salbutamol | Active comparator | 6 patients with moderate (GOLD 2) and severe (GOLD 3) COPD Receives: Drug: Salbutamol |
| ipratropium bromide | Active comparator | COPD patients GOLD stage II and III Receives: Drug: ipratropium bromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to assess the effect of a single dose of salbutamol in comparison with ipratropium bromide on central and peripheral small airways with high-resolution/multislice CT scan imaging technique.
Measured: 1 month
Secondary outcomes (1)
The secondary objectives are to evaluate effects on spirometric indices to correlate these with the CFD based calculated airway volumes and resistances for both compounds and to evaluate the safety of the products.
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 posted2 Jun 2009 (estimated)
- Study startJun 2008
- Primary completionJul 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Wilfried A De Backer, MD PhD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00911651
- Sponsor's protocol ID
- PML_DOC_0801
- Status last verified
- May 2009
- First submitted
- 28 May 2009
- Last updated
- 2 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Randomized, Two-Way Crossover, Pilot Study to Assess the Effect of Salbutamol in Comparison With Ipratropium Bromide on Central and Peripheral Airway Dimensions in COPD Patients
- ClinicalTrials.gov ID
- NCT00911651
- Acronym / sponsor ID
- PML_DOC_0801
- Conditions
- COPD
- Keywords
- COPD, salbutamol, ipratropium bromide, computational fluid dynamics, functional imaging, central and peripheral airways
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jun 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 2 Jun 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 objectives of this study are to assess the effect of salbutamol in comparison with ipratropium bromide on the geometry of central and peripheral airways and to correlate spirometric indices with the Computational Fluid Dynamics (CFD) based calculated airway volumes and resistances for both compounds.
Detailed description
Salbutamol (VentolinTM) is a short acting beta agonist (SABA) which is used to treat wheezing, dyspnea and breathing difficulties caused by asthma and COPD. Further, it is also used to prevent bronchospasm during exercise.
Ipratropium bromide (Atrovent® HFA) is a short acting anticholinergic bronchodilator (short acting muscarinic antagonist (SAMA)) that improves lung function, dyspnea, exercise tolerance and health-related quality of life in patients with COPD. Studies have also shown that ipratropium bromide might reduce COPD exacerbations and related hospitalisations because the extended bronchodilatation might reduce infection rates by improving clearance of respiratory secretions.
In this open, randomized, two-way crossover, pilot study the effect of salbutamol in patients with moderate and severe COPD will be examined in comparison with the effects of ipratropium bromide. These patients will receive 400 µg salbutamol and 80 µg ipratropium bromide in a randomized crossover design.
The objectives of this study are to assess the effect of salbutamol in comparison with ipratropium bromide on the geometry of central and peripheral airways and to correlate spirometric indices (as Forced Expiratory Volume in one second (FEV1) and Tiffeneau index) with the Computational Fluid Dynamics (CFD) based calculated airway volumes and resistances for both compounds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| salbutamol | Active comparator | Drug: Salbutamol6 patients with moderate (GOLD 2) and severe (GOLD 3) COPD |
| ipratropium bromide | Active comparator | Drug: ipratropium bromideCOPD patients GOLD stage II and III |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with documented COPD based on the following criteria:
- Patients aged ≥ 40 years.
- Patients should present moderate to severe COPD with an FEV1 between 30 and 80% of predicted (GOLD 2 and 3).
- Patients should be treated according to GOLD guidelines.
- Able to inhale study drug.
Key exclusion criteria (19 listed)
- Patients who are allergic to salbutamol, ipratropium bromide or to another element of the product.
- Patients allergic to sojalecithin and products on the basis of soja and peanut.
- Patients who have or ever had glaucoma.
- Patients with urinary problems, prostate hyperplasy or bladder-neck obstruction. Patients whose symptoms are controlled on treatment may be included.
- Patients with a recent history (i.e. six months or less) of myocardial infarction.
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 |
|---|---|---|
| SalbutamolAlso: Ventolin400 µg inhalation once | Drug | salbutamol |
| ipratropium bromideAlso: atrovent80 µg inhalation once | Drug | ipratropium bromide |
Primary outcome
The primary objective of this study is to assess the effect of a single dose of salbutamol in comparison with ipratropium bromide on central and peripheral small airways with high-resolution/multislice CT scan imaging technique.
Time frame: 1 month
1 secondary outcome
The secondary objectives are to evaluate effects on spirometric indices to correlate these with the CFD based calculated airway volumes and resistances for both compounds and to evaluate the safety of the products.
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 2 Jun 2009.
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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.
Wilfried A De Backer, MD PhD principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Salbutamol and ipratropium bromide in people with COPD, run by University Hospital, Antwerp at 1 site in Belgium.
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 10 inclusion and 19 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 2 Jun 2009. 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 Belgium. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary objective of this study is to assess the effect of a single dose of salbutamol in comparison with ipratropium bromide on central and peripheral small airways with high-resolution/multislice CT scan imaging technique. (time frame: 1 month). 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 2 Jun 2009.