Pulmonary Disease, Chronic ObstructivePhase 4NCT02182856
Ipratropium or Salbutamol Sulphate Alone or Combination Therapy Salbutamol and Ipratropium in Patients With COPD
A Phase 4 study testing Ipratropium bromide 500 µg/salbutamol sulphate 3 mg, Ipratropium 500 µg and Salbutamol sulphate 3 mg in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
Trial summary
Study to compare the effects of nebulised salbutamol or ipratropium alone in patients with COPD with those of combined salbutamol and ipratropium nebuliser solution on arterial oxygen saturation (SaO2) and to characterise patients with COPD (chronic obstructive pulmonary disease) at risk of significant arterial oxygen… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Ipratropium bromide 500 µg/salbutamol sulphate 3 mg, Ipratropium 500 µg and Salbutamol sulphate 3 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- Feb 1998to Jul 2000
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients with moderate to severe stable COPD:
- Patients with a diagnosis of chronic bronchitis and/or emphysema
- FEV1 <65% of predicted value without regard to prior treatment
- Forced expiratory ration (FER = FEV1/VC) <70% of predicted value without regard to prior treatment
- Patients must not have had a respiratory infection or an exacerbation of COPD during the four weeks immediately prior to entering the trial
- Patients must not have changed their normal treatment for COPD during the four weeks immediately prior to entering the trial
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- Patient aged ≥40 years
- Patients with a smoking history of ≥15 pack-years
- Patients must have given informed consent to participate in the trial
Who cannot join
- Patients with a diagnosis of asthma, bronchiectasis, cystic fibrosis or bronchiolitis obliterans
- Patients with any of the following:
- untreated angle closure glaucoma
- hypertrophic obstructive cardiomyopathy
- tachyarrhythmia
- recent myocardial infarction (within six months of screening visit)
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- severe organic cardiac or vascular disorder
- untreated hyperthyroidism
- diabetes mellitus (after approval of Protocol Amendment 1, the inclusion of well controlled diabetic patients was allowed)
- Patients who are pregnant, or who are planning a pregnancy, and nursing mothers
- Patients known to be hypersensitive to anticholinergic drugs or to β2 agonists
- Patients known to abuse drugs or alcohol
- Patients, who in the opinion of the investigator, are likely not to co-operate with any of the requirements of the trial
- Patients with a PaO2 (arterial carbon dioxide tension) <56 mmHg (7.5 kPa) at rest while breathing air without regard to prior treatment
- Patients with a SaO2 ≤85% at rest while breathing air without regard to prior treatment
- Patients who are taking part in another investigation, and patients who have participated in another clinical trial during the three months immediately preceding entry to this trial
- Patients on home oxygen concentrator therapy
- Patients who have previously participated in the randomised phase of this trial
About this study
Official title: A Randomised, Double-blind, Active-controlled, Within-patient Trial Comparing the Effect of Single Doses of Nebulised Ipratropium 500µg, Salbutamol Sulphate 3mg, Salbutamol 6mg and the Combination Therapy Salbutamol Sulphate 3 mg Plus Ipratropium 500µg on Arterial Oxygen Saturation in Patients With Stable, Moderate to Severe Chronic Obstructive Pulmonary Disease
Study to compare the effects of nebulised salbutamol or ipratropium alone in patients with COPD with those of combined salbutamol and ipratropium nebuliser solution on arterial oxygen saturation (SaO2) and to characterise patients with COPD (chronic obstructive pulmonary disease) at risk of significant arterial oxygen desaturation following nebulised salbutamol.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Ipratropium bromide 500 µg/salbutamol sulphate 3 mg, Ipratropium 500 µg, Salbutamol sulphate 3 mg, Salbutamol sulphate 6 mg
- 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.
Ipratropium bromide 500 µg/salbutamol sulphate 3 mgDrug
Also called Combivent® UDVs®
Ipratropium 500 µgDrug
Salbutamol sulphate 3 mgDrug
Salbutamol sulphate 6 mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Ipratropium bromide/salbutamol sulphate | Experimental | Randomised sequence of four different treatments
1. Ipratropium bromide 500 µg/salbutamol sulphate 3 mg
2. Ipratropium 500 µg
3. Salbutamol sulphate 3 mg
4. Salbutamol sulphate 6 mg Receives: Drug: Ipratropium bromide 500 µg/salbutamol sulphate 3 mg; Drug: Ipratropium 500 µg; Drug: Salbutamol sulphate 3 mg; Drug: Salbutamol sulphate 6 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve of arterial oxygen saturation (SaO2)
Measured: over 70 min observation period from each start of nebulisation
Secondary outcomes (4)
Forced expiratory volume in the first second of expiration (FEV1)
Measured: up to 60 min after end of nebulisation
Relaxed (expiratory) vital capacity (VC)
Measured: up to 60 min after end of nebulisation
Forced (expiratory) vital capacity (FVC)
Measured: up to 60 min after end of nebulisation
Forced expiratory ratio (FER)
Measured: up to 60 min after end of nebulisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startFeb 1998
- Primary completionJul 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02182856
- Sponsor's protocol ID
- 1012.39
- Status last verified
- Jul 2014
- First submitted
- 4 Jul 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Active-controlled, Within-patient Trial Comparing the Effect of Single Doses of Nebulised Ipratropium 500µg, Salbutamol Sulphate 3mg, Salbutamol 6mg and the Combination Therapy Salbutamol Sulphate 3 mg Plus Ipratropium 500µg on Arterial Oxygen Saturation in Patients With Stable, Moderate to Severe Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02182856
- Acronym / sponsor ID
- 1012.39
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 1998
- Primary completion
- Jul 2000 (actual)
- First posted
- 8 Jul 2014 (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.
Study to compare the effects of nebulised salbutamol or ipratropium alone in patients with COPD with those of combined salbutamol and ipratropium nebuliser solution on arterial oxygen saturation (SaO2) and to characterise patients with COPD (chronic obstructive pulmonary disease) at risk of significant arterial oxygen desaturation following nebulised salbutamol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ipratropium bromide/salbutamol sulphate | Experimental | Drug: Ipratropium bromide 500 µg/salbutamol sulphate 3 mg, Drug: Ipratropium 500 µg, Drug: Salbutamol sulphate 3 mg, Drug: Salbutamol sulphate 6 mgRandomised sequence of four different treatments 1. Ipratropium bromide 500 µg/salbutamol sulphate 3 mg 2. Ipratropium 500 µg 3. Salbutamol sulphate 3 mg 4. Salbutamol sulphate 6 mg |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and female patients with moderate to severe stable COPD:
- Patient aged ≥40 years
- Patients with a smoking history of ≥15 pack-years
- Patients must have given informed consent to participate in the trial
Key exclusion criteria (18 listed)
- Patients with a diagnosis of asthma, bronchiectasis, cystic fibrosis or bronchiolitis obliterans
- Patients with any of the following:
- Patients who are pregnant, or who are planning a pregnancy, and nursing mothers
- Patients known to be hypersensitive to anticholinergic drugs or to β2 agonists
- Patients known to abuse drugs or alcohol
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 |
|---|---|---|
| Ipratropium bromide 500 µg/salbutamol sulphate 3 mgAlso: Combivent® UDVs® | Drug | Ipratropium bromide/salbutamol sulphate |
| Ipratropium 500 µg | Drug | Ipratropium bromide/salbutamol sulphate |
| Salbutamol sulphate 3 mg | Drug | Ipratropium bromide/salbutamol sulphate |
| Salbutamol sulphate 6 mg | Drug | Ipratropium bromide/salbutamol sulphate |
Primary outcome
Area under the curve of arterial oxygen saturation (SaO2)
Time frame: over 70 min observation period from each start of nebulisation
4 secondary outcomes
Forced expiratory volume in the first second of expiration (FEV1)
Time frame: up to 60 min after end of nebulisation
Relaxed (expiratory) vital capacity (VC)
Time frame: up to 60 min after end of nebulisation
Forced (expiratory) vital capacity (FVC)
Time frame: up to 60 min after end of nebulisation
Forced expiratory ratio (FER)
Time frame: up to 60 min after end of nebulisation
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 8 Jul 2014.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ipratropium bromide 500 µg/salbutamol sulphate 3 mg, Ipratropium 500 µg and Salbutamol sulphate 3 mg in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
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 9 inclusion and 18 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 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Area under the curve of arterial oxygen saturation (SaO2) (time frame: over 70 min observation period from each start of nebulisation). 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 8 Jul 2014.