Pulmonary Disease, Chronic ObstructivePhase 2NCT02182869
Combivent® HFA-propelled Compared to CFC-propelled Metered Dose Inhaler in Patients With COPD (Chronic Obstructive Pulmonary Disease)
A Phase 2 study testing Combivent® HFA inhalation aerosol and Combivent® CFC inhalation aerosol in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
Trial summary
Study to evaluate the safety of combivent delivered in two different formulations (hydrofluoroalkane (HFA) or chlorofluorocarbon (CFC)) from a metered dose inhaler (MDI), using a cumulative dose response model in patients with COPD. 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?
- Combivent® HFA inhalation aerosol and Combivent® CFC inhalation aerosol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- Apr 2001to Aug 2001
- Phase
- Phase 2
- 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 or female patients 40 years of age or older
- A diagnosis of COPD as defined by American Thoracic Society (ATS) criteria. Patients must have relatively stable, moderate to severe airway obstruction with a baseline FEV 1 <=65% of predicted normal and FEV1/FVC >=70%.
- A smoking history of more than ten pack-years. A pack-year is defined as the equivalent of smoking one pack of 20 cigarettes per day for a year
- Able to perform technical satisfactory pulmonary function test
- Able to be trained in the proper use of a MDI
- Having signed an informed consent from prior to participation in the trial
- Affiliation to the French social security system or beneficiary of such a system
Who cannot join
- Significant disease other than COPD. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study
- Clinical relevant abnormal baseline hematology, blood chemistry or urinalysis. If the abnormality defines a disease listed as an exclusion criterion, the patient is excluded
- Serum glutamic oxaloacetic transaminase (SGOT) >80 IU/L; serum glutamic pyruvic transaminase (SGPT) >80IU/L, bilirubin >2.0mg/dL or creatinine >2.0mg/dL
- Serum potassium level above or below the normal range
- Total blood eosinophil count >=600/mm³
- Recent history (i.e., one year or less) of myocardial infarction
Show all 33Show fewer
- Recent history (i.e., three years or less) of heart failure or any cardiac arrhythmia requiring drug therapy
- History of cancer, other than treated basal cell carcinoma, within the last five years
- History of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis
- History of thoracotomy with pulmonary resection. History or a thoracotomy for other reasons should be evaluated as per exclusion criteria no. 1
- History of asthma, allergic rhinitis or atopy
- History of or active alcohol or drug abuse
- Known active tuberculosis
- Upper respiratory tract infection or COPD exacerbation in the six weeks prior to screening visit or between the screening visit and visit 2
- Known symptomatic prostatic hypertrophy or bladder neck obstruction
- Known narrow-angle glaucoma
- Current significant psychiatric disorders
- Regular use of daytime oxygen therapy
- Use of beta-blocker medications, mono-amine oxidase inhibitors or tricyclic antidepressants
- Use of cromolyn sodium or nedocromil sodium
- Use of antihistamines.
- Use of oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose before screening visit or a change between the screening visit and visit2) or at a dose in excess of the equivalent of 10 mg of prednisone per day or 20mg every other day
- Use of oral beta-adrenergics or long-acting beta-adrenergics such as salmeterol (Serevent®) and formoterol in the two weeks prior to the screening visit or between the screening visit and visit 2
- Changes in the therapeutic plan within the last six weeks prior to the screening visit or between the screening visit and visit 2, excluding changes from long acting or oral beta-adrenergics to short acting inhaled beta-adrenergics for purposes of this trial
- Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception
- Known hypersensitivity to anti-cholinergic or beta-agonist drugs or any other component of either Combivent® formulations
- Use of an investigational drug within one month or six half lives prior to the screening visit
- Previous participation in this study
- Patient deprived of their freedom by a judicial or administrative decision
- Patient leaving in medical or social establishments
- Patient hospitalized for mental disorder without his (her) consent
- Patient under guardianship
- Patient in emergency situations
About this study
Official title: Safety Assessment of Cumulative Dose of Combivent® HFA-propelled Metered Dose Inhaler in Comparison to Combivent® CFC-propelled Metered Dose Inhaler. A Randomised, Double-blind, Active-controlled, Two-way Cross-over Study in COPD Patients
Study to evaluate the safety of combivent delivered in two different formulations (hydrofluoroalkane (HFA) or chlorofluorocarbon (CFC)) from a metered dose inhaler (MDI), using a cumulative dose response model in patients with COPD.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Combivent® HFA inhalation aerosol, Combivent® CFC inhalation aerosol
- 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.
Combivent® HFA inhalation aerosolDrug
Combivent® CFC inhalation aerosolDrug
| Study group | Role | What they receive |
|---|---|---|
| Combivent® HFA | Experimental | Not described Receives: Drug: Combivent® HFA inhalation aerosol |
| Combivent® CFC | Active comparator | Not described Receives: Drug: Combivent® CFC inhalation aerosol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with clinically significant changes in electrocardiogram (ECG) parameters (ventricular rate, PQ, QRS, QT and QTc intervals)
Measured: Baseline, up to 8 days after last treatment day
Number of patients with clinically significant changes in vital signs (blood pressure, puls rate, respiratory rate)
Measured: Baseline, up to 8 days after last treatment day
Changes in intra ocular pressure (IOP)
Measured: Baseline, up to 30 min after last drug administration
Changes in serum potassium levels
Measured: Baseline, up to 180 min after last drug administration
Changes in serum glucose levels
Measured: Baseline, up to 60 min after last drug administration
Number of patients with clinically significant changes from baseline in clinical laboratory evaluations
Measured: Baseline, 8 days after last treatment day
Number of patients with adverse events including paradoxical bronchospasm
Measured: Up to 8 days after last treatment day
Number of patients with clinically significant changes from baseline in physical examination
Measured: Baseline, 8 days after last treatment day
Secondary outcomes (2)
Change in FEV1 (forced expiratory volume in one second)
Measured: Baseline, up to 180 min after last drug administration
Change in FVC (forced vital capacity)
Measured: Baseline, up to 180 min after last drug administration
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 startApr 2001
- Primary completionAug 2001
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 7 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
- NCT02182869
- Sponsor's protocol ID
- 1012.43
- Status last verified
- Aug 2018
- First submitted
- 4 Jul 2014
- Last updated
- 31 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Assessment of Cumulative Dose of Combivent® HFA-propelled Metered Dose Inhaler in Comparison to Combivent® CFC-propelled Metered Dose Inhaler. A Randomised, Double-blind, Active-controlled, Two-way Cross-over Study in COPD Patients
- ClinicalTrials.gov ID
- NCT02182869
- Acronym / sponsor ID
- 1012.43
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2001
- Primary completion
- Aug 2001 (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 evaluate the safety of combivent delivered in two different formulations (hydrofluoroalkane (HFA) or chlorofluorocarbon (CFC)) from a metered dose inhaler (MDI), using a cumulative dose response model in patients with COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combivent® HFA | Experimental | Drug: Combivent® HFA inhalation aerosol |
| Combivent® CFC | Active comparator | Drug: Combivent® CFC inhalation aerosol |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patients 40 years of age or older
- A diagnosis of COPD as defined by American Thoracic Society (ATS) criteria. Patients must have relatively stable, moderate to severe airway obstruction with a baseline FEV 1 <=65% of predicted normal and FEV1/FVC >=70%.
- A smoking history of more than ten pack-years. A pack-year is defined as the equivalent of smoking one pack of 20 cigarettes per day for a year
- Able to perform technical satisfactory pulmonary function test
- Able to be trained in the proper use of a MDI
Key exclusion criteria (33 listed)
- Significant disease other than COPD. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study
- Clinical relevant abnormal baseline hematology, blood chemistry or urinalysis. If the abnormality defines a disease listed as an exclusion criterion, the patient is excluded
- Serum glutamic oxaloacetic transaminase (SGOT) >80 IU/L; serum glutamic pyruvic transaminase (SGPT) >80IU/L, bilirubin >2.0mg/dL or creatinine >2.0mg/dL
- Serum potassium level above or below the normal range
- Total blood eosinophil count >=600/mm³
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 |
|---|---|---|
| Combivent® HFA inhalation aerosol | Drug | Combivent® HFA |
| Combivent® CFC inhalation aerosol | Drug | Combivent® CFC |
Primary outcome
Number of patients with clinically significant changes in electrocardiogram (ECG) parameters (ventricular rate, PQ, QRS, QT and QTc intervals)
Time frame: Baseline, up to 8 days after last treatment day
Number of patients with clinically significant changes in vital signs (blood pressure, puls rate, respiratory rate)
Time frame: Baseline, up to 8 days after last treatment day
Changes in intra ocular pressure (IOP)
Time frame: Baseline, up to 30 min after last drug administration
Changes in serum potassium levels
Time frame: Baseline, up to 180 min after last drug administration
Changes in serum glucose levels
Time frame: Baseline, up to 60 min after last drug administration
Number of patients with clinically significant changes from baseline in clinical laboratory evaluations
Time frame: Baseline, 8 days after last treatment day
Number of patients with adverse events including paradoxical bronchospasm
Time frame: Up to 8 days after last treatment day
Number of patients with clinically significant changes from baseline in physical examination
Time frame: Baseline, 8 days after last treatment day
2 secondary outcomes
Change in FEV1 (forced expiratory volume in one second)
Time frame: Baseline, up to 180 min after last drug administration
Change in FVC (forced vital capacity)
Time frame: Baseline, up to 180 min after last drug administration
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
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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 2 study testing Combivent® HFA inhalation aerosol and Combivent® CFC inhalation aerosol 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 7 inclusion and 33 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 31 Aug 2018. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early. 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?
Number of patients with clinically significant changes in electrocardiogram (ECG) parameters (ventricular rate, PQ, QRS, QT and QTc intervals) (time frame: Baseline, up to 8 days after last treatment day). The study lists 8 primary outcomes in all. 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 31 Aug 2018.