Pulmonary Disease, Chronic ObstructivePhase 3NCT00239434
A Comparison of 18g of Tiotropium Inhalation Capsules Once Daily and Atrovent Metered Dose Inhaler (2 Puffs of 20g, 4 Times Daily) in a Double-Blind, Double-Dummy, Efficacy and Safety Study in Adults With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study testing tiotropium inhalation powder capsule and ipratropium bromide Metered Dose Inhaler in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 6 sites in China.
Trial summary
The objective of this study is to compare the bronchodilator efficacy and safety of once daily dosing of tiotropium inhalation capsules (18 ?g) and Atrovent? MDI (2 puffs of ipratropium bromide 20 ?g four times daily) in patients with chronic obstructive pulmonary disease. 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?
- tiotropium inhalation powder capsule and ipratropium bromide Metered Dose Inhaler
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 6 sitesChina
- Study dates
- Jun 2003to Mar 2004
- Phase
- Phase 3
- 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 chronic obstructive pulmonary disease according to the following criteria:
- Patients must have relatively stable airway obstruction with an FEV1 ? 65% of predicted normal and FEV1 70% of FVC.
- Predicted normal values will be based on the following formula. Males: FEV1 pred.(L) = height2(m) x (-0.016 x age(year) + 1.823) Females: FEV1 pred.(L) = height2(m) x (-0.012 x age(year) + 1.4427)
- Male or female patients 40 years of age 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 per day for a year.
- Patients must be able to perform pulmonary function tests as required in the protocol.
- Patients must be able to inhale medication from the HandiHaler device and should have a good technique of inhaling aerosol administered from an MDI.
- 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.
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 which may influence the results of the study or the patient's ability to participate in the study.
- Patients with clinically significant abnormal baseline hematology, blood chemistry or urinalysis, if the abnormality defines a disease listed as an exclusion criterion will be excluded.
- All patients with a SGOT and SGPT twice the normal range, bilirubin 150% or creatinine 125% of the normal range will be excluded regardless of the clinical condition. Repeat laboratory evaluation will not be conducted in these subjects.
- Patients with a recent history (i.e. one year or less) of myocardial infarction.
- Patients with a recent history (i.e. three years or less) of heart failure or patients with any cardiac arrhythmia requiring drug therapy.
- Patients with regular use of daytime oxygen therapy.
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- Patients with known active tuberculosis.
- Patients with a history of cancer within the last five 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 pulmonary resection.
- Patients with an upper respiratory tract infection in the past 6 weeks prior to the Screening Visit (=Visit 1) or during the baseline period of 2-weeks (run-in period).
- Patients with known hypersensitivity to anticholinergic drugs, lactose or any other component of the inhalation capsule delivery system or the MDI.
- Patients with known symptomatic prostatic hyperplasia or bladder neck obstruction.
- Patients with known narrow-angle glaucoma.
- Patients who are being treated with cromolyn sodium or nedocromil sodium.
- Patients who are being treated with antihistamines.
- Patients using oral corticosteroid medication at unstable (i.e. less than 6 weeks on a stable dose) or at a dose in excess of the equivalent 10 mg of prednisone per day or 20 mg every other day.
- Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (e.g. oral contraceptives, intrauterine devices, or diaphragm).
- Patients with a history of asthma, allergic rhinitis or atopy or who have a blood total eosinophil count >= 400 per µl (males) or >= 320 per µl (females). A repeat eosinophil count will not be conducted in these patients.
- Patients with a history and/or active alcohol or drug abuse.
- Patients who have taken an investigational drug one month or six half-lives (whichever is greater) prior to the Screening Visit (=Visit 1).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
People Hospital of Beijing University
Beijing, 100044
Peking Union Medical College Hospital
Beijing, 100730
1st Hospital of Guangzhou Medical College
Guangzhou, 510120
Zhongshan Hospital of Fudan University
Shanghai, 200032
Shanghai 1st People Hospital
Shanghai, 200080
1st Hospital of Chinese Medical University
Shenyang, 110001
About this study
Official title: Comparison of 18 mg of Tiotropium Inhalation Capsules Once Daily and Atrovent Metered Dose Inhaler (2 Puffs of 20 mg, Four Times Daily) in a Double-Blind, Double-dummy, Efficacy and Safety Study in Adults With Chronic Obstructive Pulmonary Disease (COPD).
The objective of this study is to compare the bronchodilator efficacy and safety of once daily dosing of tiotropium inhalation capsules (18 ?g) and Atrovent? MDI (2 puffs of ipratropium bromide 20 ?g four times daily) in patients with chronic obstructive pulmonary disease.
Read the detailed description
This is a randomized, double-blind, double-dummy, parallel group study to compare the bronchodilator efficacy and safety of tiotropium inhalation capsules and Atrovent? MDI in patients with chronic obstructive pulmonary disease (COPD).
Following an initial screening visit, patients will enter a 2-week baseline period. Patients who successfully complete this phase will be randomized into the double-blind portion of the study in which they will receive tiotropium once daily (morning) or Atrovent? four times daily for 4 weeks. Pulmonary function testing will be conducted just prior (i.e. 5 minutes before) to the start of therapy at Visit 2 (i.e. randomization visit after completion of the 2-week run-in period) and at 30, 60, 120 and 180 minutes post-dosing. Pulmonary function testing will be repeated at the same time intervals after 14 days of therapy (visit 3) and at the end of therapy.
Those patients taking theophylline, will be questioned about their last theophylline intake in order to ensure adherence to the washout requirements.
Vital signs will be measured in conjunction with the pulmonary function tests. Adverse events will be recorded throughout the entire run-in and treatment period.
Study Hypothesis:
The null hypothesis is that there is no difference in mean response between tiotropium and Atrovent. The alternative hypothesis is that there is a difference in mean response between tiotropium and Atrovent.
Comparison(s):
The primary pulmonary function variable will be FEV1 (Forced Expiratory Volume in one second) and trough FEV1 response at the end of the four week treatment period, i.e. visit 4, will be the primary efficacy endpoint.
Trough FEV1 is defined as FEV1 at the end of the dosing interval (for tiotropium at approximately 24 hours post treatment administration). On test days (Visits 3 and 4) it is measured by the PFT just prior to dosing. Trough FEV1 response is defined as change from baseline in trough FEV1. Baseline FEV1 is defined as FEV1 measured just prior to first dosing in the morning of randomization visit (Visit 2).
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- tiotropium inhalation powder capsule, ipratropium bromide Metered Dose Inhaler
- 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.
tiotropium inhalation powder capsuleDrug
ipratropium bromide Metered Dose InhalerDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Trough FEV1 response: change from baseline trough FEV1 (visit 2) at visit 4
Secondary outcomes (1)
Trough FEV1 response at visit 3 Average FEV1 (AUC0-3) response (change from baseline) for the 3 hours post drug administration Trough FVC response Average FVC (AUC0-3) response (as defined for FEV1) 5. Amount of rescue medication 6. Patient questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2005 (estimated)
- Study startJun 2003
- Study completionMar 2004
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, Boehringer Ingelheim Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00239434
- Sponsor's protocol ID
- 205.245
- Status last verified
- May 2012
- First submitted
- 14 Oct 2005
- Last updated
- 14 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 18 mg of Tiotropium Inhalation Capsules Once Daily and Atrovent Metered Dose Inhaler (2 Puffs of 20 mg, Four Times Daily) in a Double-Blind, Double-dummy, Efficacy and Safety Study in Adults With Chronic Obstructive Pulmonary Disease (COPD).
- ClinicalTrials.gov ID
- NCT00239434
- Acronym / sponsor ID
- 205.245
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Study completion
- Mar 2004
- First posted
- 17 Oct 2005 (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 is to compare the bronchodilator efficacy and safety of once daily dosing of tiotropium inhalation capsules (18 ?g) and Atrovent? MDI (2 puffs of ipratropium bromide 20 ?g four times daily) in patients with chronic obstructive pulmonary disease.
Detailed description
This is a randomized, double-blind, double-dummy, parallel group study to compare the bronchodilator efficacy and safety of tiotropium inhalation capsules and Atrovent? MDI in patients with chronic obstructive pulmonary disease (COPD).
Following an initial screening visit, patients will enter a 2-week baseline period. Patients who successfully complete this phase will be randomized into the double-blind portion of the study in which they will receive tiotropium once daily (morning) or Atrovent? four times daily for 4 weeks. Pulmonary function testing will be conducted just prior (i.e. 5 minutes before) to the start of therapy at Visit 2 (i.e. randomization visit after completion of the 2-week run-in period) and at 30, 60, 120 and 180 minutes post-dosing. Pulmonary function testing will be repeated at the same time intervals after 14 days of therapy (visit 3) and at the end of therapy.
Those patients taking theophylline, will be questioned about their last theophylline intake in order to ensure adherence to the washout requirements.
Vital signs will be measured in conjunction with the pulmonary function tests. Adverse events will be recorded throughout the entire run-in and treatment period.
Study Hypothesis:
The null hypothesis is that there is no difference in mean response between tiotropium and Atrovent. The alternative hypothesis is that there is a difference in mean response between tiotropium and Atrovent.
Comparison(s):
The primary pulmonary function variable will be FEV1 (Forced Expiratory Volume in one second) and trough FEV1 response at the end of the four week treatment period, i.e. visit 4, will be the primary efficacy endpoint.
Trough FEV1 is defined as FEV1 at the end of the dosing interval (for tiotropium at approximately 24 hours post treatment administration). On test days (Visits 3 and 4) it is measured by the PFT just prior to dosing. Trough FEV1 response is defined as change from baseline in trough FEV1. Baseline FEV1 is defined as FEV1 measured just prior to first dosing in the morning of randomization visit (Visit 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
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 chronic obstructive pulmonary disease according to the following criteria:
- Patients must have relatively stable airway obstruction with an FEV1 ? 65% of predicted normal and FEV1 70% of FVC.
- Predicted normal values will be based on the following formula. Males: FEV1 pred.(L) = height2(m) x (-0.016 x age(year) + 1.823) Females: FEV1 pred.(L) = height2(m) x (-0.012 x age(year) + 1.4427)
- Male or female patients 40 years of age 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 per day for a year.
Key exclusion criteria (21 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 which may influence the results of the study or the patient's ability to participate in the study.
- Patients with clinically significant abnormal baseline hematology, blood chemistry or urinalysis, if the abnormality defines a disease listed as an exclusion criterion will be excluded.
- All patients with a SGOT and SGPT twice the normal range, bilirubin 150% or creatinine 125% of the normal range will be excluded regardless of the clinical condition. Repeat laboratory evaluation will not be conducted in these subjects.
- Patients with a recent history (i.e. one year or less) of myocardial infarction.
- Patients with a recent history (i.e. three years or less) of heart failure or patients with any cardiac arrhythmia requiring drug therapy.
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 inhalation powder capsule | Drug | – |
| ipratropium bromide Metered Dose Inhaler | Drug | – |
Primary outcome
Trough FEV1 response: change from baseline trough FEV1 (visit 2) at visit 4
1 secondary outcome
Trough FEV1 response at visit 3 Average FEV1 (AUC0-3) response (change from baseline) for the 3 hours post drug administration Trough FVC response Average FVC (AUC0-3) response (as defined for FEV1) 5. Amount of rescue medication 6. Patient questionnaire
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 14 May 2012.
- 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.
Boehringer Ingelheim Study Coordinator study chair
Boehringer Ingelheim Shanghai
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tiotropium inhalation powder capsule and ipratropium bromide Metered Dose Inhaler in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 6 sites in China.
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 21 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 14 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Trough FEV1 response: change from baseline trough FEV1 (visit 2) at visit 4. 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 14 May 2012.