Pulmonary Disease, Chronic ObstructivePhase 2NCT02236169
Trial to Determine the Comparability of Ipratropium Bromide Hydrofluoroalkane (HFA)-134a Inhalation Aerosol to ATROVENT® Chlorofluorocarbon (CFC) Inhalation Aerosol, in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study testing Ipratropium bromide HFA-134a inhalation aerosol and Atrovent CFC inhalation aerosol in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
Trial summary
The objective of this study was to determine the pharmacokinetic comparability of 84 µg ipratropium bromide HFA-134a inhalation aerosol and 84 µg ATROVENT® CFC Inhalation Aerosol in COPD patients 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 HFA-134a inhalation aerosol and Atrovent CFC inhalation aerosol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2000to Apr 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
- All patients must have a diagnosis of COPD and must meet the following spirometric criteria:
- Patients must have a stable, moderate to severe airway obstruction with an Forced Expiratory Volume in one second (FEV1) <=65% of predicted normal and FEV1 <=70% of Forced vital capacity (FVC)
- Males: Predicted Normal FEV1 = 0.093 (height in inches)-0.032 (age)-1.343
- Females: Predicted Normal FEV1 = 0.085 (height in inches)-0.025(age)-1.692
- Male or female age 40 years or older
- Patients must have a smoking history of more than 10 pack-years. A pack-year is defined as the equivalent of smoking one pack of cigarettes (20 cigarettes) per day for a year
- Patients must be able to satisfactorily administer the medication, perform pulmonary function tests (PFTs) and maintain records during the study period as required in the protocol
- All patients must sign an Informed Consent Form prior to participation in the trial (i.e., prior to pre-study washout of their usual pulmonary medications and prior to fasting for laboratory tests)
Who cannot join
- Patients with significant diseases other than COPD will be excluded. 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 with may influence the results of the study or patients ability to participate in the study
- Patients with clinically relevant baseline hematology, blood chemistry or urinalysis. If the abnormality defines a disease listed as an exclusion criterion the patient is excluded
- All patients with serum glutamic oxaloacetic transaminase (SGOT) >80 IU/L, serum glutamic pyruvic transaminase (SGPT) >80 IU/L, bilirubin >2.0 mg/dl, or creatinine >2.0 mg/dl will be excluded regardless of the clinical condition. Repeat laboratory evaluation will be not be conducted in these patients
- Patients with a history of asthma, allergic rhinitis or atopy or who have a blood eosinophil count above 600/mm3. A repeat eosinophil count will be not be conducted in these patients
- Patients with a recent (i.e., one year or less) history of myocardial infarction
- Patients with a recent history (i.e., three years or less) of cardiac failure, patients with cardiac arrhythmia requiring therapy, patients receiving any systemic beta-blockers and patients on chronic daytime oxygen therapy
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- Patients with known active tuberculosis
- Patients with a history of cancer within the last 5 years. Patients with treated basal cell carcinoma are allowed
- Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis
- Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reason should be evaluated per exclusion criterion No.1
- Patients with an upper respiratory tract infection or COPD exacerbation in the 6 weeks prior to the screening visit (Visit 1) or during the baseline period
- Patients with known hypersensitivity to anticholinergic drugs
- Patients with known symptomatic prostatic hypertrophy or bladder-neck obstruction
- Patients with known narrow-angle glaucoma
- Patients who are on cromolyn sodium or nedocromil sodium
- Patients who are on antihistamines
- Pregnant or nursing women and women of childbearing potential not using a medically approved means of contraception (e.g., oral contraceptive, intrauterine devices, diaphragm or Norplant®)
- Patients who have taken an investigational drug within 1 month or 6 half-lives (whichever is longer) of the drug prior to the screening visit or patients currently enrolled in another research study
- Patients with a history of and/or active alcohol or drug abuse
About this study
Official title: An Open-Label, Crossover, Pharmacokinetic Trial to Determine the Comparability of 84 µg Ipratropium Bromide HFA-134a Inhalation Aerosol to 84 µg ATROVENT® CFC Inhalation Aerosol, in Patients With Chronic Obstructive Pulmonary Disease (COPD)
The objective of this study was to determine the pharmacokinetic comparability of 84 µg ipratropium bromide HFA-134a inhalation aerosol and 84 µg ATROVENT® CFC Inhalation Aerosol in COPD patients
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Ipratropium bromide HFA-134a inhalation aerosol, Atrovent 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.
Ipratropium bromide HFA-134a inhalation aerosolDrug
Atrovent CFC inhalation aerosolDrug
| Study group | Role | What they receive |
|---|---|---|
| Ipratropium bromide | Experimental | Not described Receives: Drug: Ipratropium bromide HFA-134a inhalation aerosol |
| ATROVENT | Active comparator | Not described Receives: Drug: Atrovent CFC inhalation aerosol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of unchanged ipratropium excreted in the urine from 0 to 24 h after a single dose
Measured: Up to 24 hours (h) after single drug administration
Amount of unchanged ipratropium excreted in the urine within 1 hour at steady state
Measured: 1h after drug administration
Amount of unchanged ipratropium excreted in the urine over the 6 h dosing interval at steady state
Measured: up to 6 h after drug administration
Secondary outcomes (13)
Area under the plasma ipratropium concentration time curve at different time points
Measured: Up to 23 days after first drug administration
Peak plasma ipratropium concentration at different time points
Measured: Up to 23 days after first drug administration
Trough plasma ipratropium concentration at different time points
Measured: Up to 23 days after first drug administration
Time to peak plasma ipratropium concentrations at steady state
Measured: Up to 23 days after first drug administration
Degree of fluctuation (DF) of the plasma ipratropium concentrations
Measured: Up to 23 days after first drug administration
Area under the plasma ipratropium concentration time curve
Measured: Day 1 after first drug administration
Peak plasma ipratropium concentration
Measured: Day 1 after first drug administration
Number of patients with adverse events
Measured: Up to 23 days after first drug administration
Changes from baseline in pulse rate and blood pressure
Measured: Baseline, day 23 day after first drug administration
Number of patients with clinical significant findings in laboratory tests
Measured: Up to 23 days after first drug administration
Number of patients with clinical significant findings in physical examination
Measured: Up to 23 days after first drug administration
Number of patients with clinical significant findings in electrocardiogram (ECG)
Measured: Up to 23 days after first drug administration
Changes from test-day baseline in pulse rate and blood pressure
Measured: Up to 23 days after first drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startOct 2000
- Primary completionApr 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
- None (open label)
- Enrolment
- 30 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
- NCT02236169
- Sponsor's protocol ID
- 244.2480
- Status last verified
- Sep 2014
- First submitted
- 9 Sep 2014
- Last updated
- 10 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Crossover, Pharmacokinetic Trial to Determine the Comparability of 84 µg Ipratropium Bromide HFA-134a Inhalation Aerosol to 84 µg ATROVENT® CFC Inhalation Aerosol, in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT02236169
- Acronym / sponsor ID
- 244.2480
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 2000
- Primary completion
- Apr 2001 (actual)
- First posted
- 10 Sep 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.
The objective of this study was to determine the pharmacokinetic comparability of 84 µg ipratropium bromide HFA-134a inhalation aerosol and 84 µg ATROVENT® CFC Inhalation Aerosol in COPD patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ipratropium bromide | Experimental | Drug: Ipratropium bromide HFA-134a inhalation aerosol |
| ATROVENT | Active comparator | Drug: Atrovent 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 (8 listed)
- All patients must have a diagnosis of COPD and must meet the following spirometric criteria:
- Patients must have a stable, moderate to severe airway obstruction with an Forced Expiratory Volume in one second (FEV1) <=65% of predicted normal and FEV1 <=70% of Forced vital capacity (FVC)
- Male or female age 40 years or older
- Patients must have a smoking history of more than 10 pack-years. A pack-year is defined as the equivalent of smoking one pack of cigarettes (20 cigarettes) per day for a year
- Patients must be able to satisfactorily administer the medication, perform pulmonary function tests (PFTs) and maintain records during the study period as required in the protocol
Key exclusion criteria (19 listed)
- Patients with significant diseases other than COPD will be excluded. 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 with may influence the results of the study or patients ability to participate in the study
- Patients with clinically relevant baseline hematology, blood chemistry or urinalysis. If the abnormality defines a disease listed as an exclusion criterion the patient is excluded
- All patients with serum glutamic oxaloacetic transaminase (SGOT) >80 IU/L, serum glutamic pyruvic transaminase (SGPT) >80 IU/L, bilirubin >2.0 mg/dl, or creatinine >2.0 mg/dl will be excluded regardless of the clinical condition. Repeat laboratory evaluation will be not be conducted in these patients
- Patients with a history of asthma, allergic rhinitis or atopy or who have a blood eosinophil count above 600/mm3. A repeat eosinophil count will be not be conducted in these patients
- Patients with a recent (i.e., one year or less) history 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 |
|---|---|---|
| Ipratropium bromide HFA-134a inhalation aerosol | Drug | Ipratropium bromide |
| Atrovent CFC inhalation aerosol | Drug | ATROVENT |
Primary outcome
Amount of unchanged ipratropium excreted in the urine from 0 to 24 h after a single dose
Time frame: Up to 24 hours (h) after single drug administration
Amount of unchanged ipratropium excreted in the urine within 1 hour at steady state
Time frame: 1h after drug administration
Amount of unchanged ipratropium excreted in the urine over the 6 h dosing interval at steady state
Time frame: up to 6 h after drug administration
13 secondary outcomes
Area under the plasma ipratropium concentration time curve at different time points
Time frame: Up to 23 days after first drug administration
Peak plasma ipratropium concentration at different time points
Time frame: Up to 23 days after first drug administration
Trough plasma ipratropium concentration at different time points
Time frame: Up to 23 days after first drug administration
Time to peak plasma ipratropium concentrations at steady state
Time frame: Up to 23 days after first drug administration
Degree of fluctuation (DF) of the plasma ipratropium concentrations
Time frame: Up to 23 days after first drug administration
Area under the plasma ipratropium concentration time curve
Time frame: Day 1 after first drug administration
Peak plasma ipratropium concentration
Time frame: Day 1 after first drug administration
Number of patients with adverse events
Time frame: Up to 23 days after first drug administration
Changes from baseline in pulse rate and blood pressure
Time frame: Baseline, day 23 day after first drug administration
Number of patients with clinical significant findings in laboratory tests
Time frame: Up to 23 days after first drug administration
Number of patients with clinical significant findings in physical examination
Time frame: Up to 23 days after first drug administration
Number of patients with clinical significant findings in electrocardiogram (ECG)
Time frame: Up to 23 days after first drug administration
Changes from test-day baseline in pulse rate and blood pressure
Time frame: Up to 23 days after first drug administration
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 10 Sep 2014.
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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 Ipratropium bromide HFA-134a inhalation aerosol and Atrovent 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 8 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 10 Sep 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 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 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?
Amount of unchanged ipratropium excreted in the urine from 0 to 24 h after a single dose (time frame: Up to 24 hours (h) after single drug administration). The study lists 3 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 10 Sep 2014.