Pulmonary Disease, Chronic ObstructivePhase 3NCT00274040
Comparison of Tiotropium and Ipratropium in a Double-Blind, Double-dummy, Efficacy and Safety Study in Adults With COPD
A Phase 3 study testing Tiotropium and Ipratropium in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 18 sites in South Korea.
Trial summary
Comparison of 18 mcg of Tiotropium Inhalation Capsules and ipratropiumMetered Dose Inhaler (2 puffs of 20 mcg, four times daily) in a Double-Blind, Double-dummy, Efficacy and Safety Study in Adults with Chronic Obstructive Pulmonary Disease (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?
- Tiotropium and Ipratropium
- How many people
- 141 participants
- Where
- 18 sitesSouth Korea
- Study dates
- Jul 2002to Mar 2003
- 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 formulas as supplied by the individual study sites."
- 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 or a thoracotomy for any reason.
- 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 hypertrophy 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 mcl (males) or 320>= per mcl (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
18 sites in 1 country.
18 sites in 1 country
South Korea18 sites
Chungnam National University Hospital
Daejeon
Jeonbuk National University Hospital
Jeonju
Jeonnam National University Hospital
Kwangju
Pusan University Hospital
Pusan
Chung-ang University Hospital
Seoul
Hanyang University Hosital
Seoul
Kangnam St. Mary's Hospital
Seoul
Korea University Hospital
Seoul
Kyoungbuk National University Hospital
Seoul
Kyunghee University Hospital
Seoul
National Medical Center
Seoul
Samsung Seoul Hospital
Seoul
Seoul Asan Hospital
Seoul
Seoul National University Hospital
Seoul
Shinchon Severence Hosp (Yonsei University Hosp)
Seoul
St. Paul's Hospital, Dept. of Respiratory
Seoul
Youngdong Sevarence Hospital (Yonsei University Hospital)
Seoul
Wonju Christian Hospital (Yonsei University Hosp)
Wŏnju
About this study
Official title: A Comparison of 18 μg of Tiotropium Inhalation Capsules and Atrovent Metered Dose Inhaler (2 Puffs of 20 μg, 4 Times Daily) in a Double-Blind, Double-Dummy, Efficacy and Safety Study in Adults With Chronic Obstructive Pulmonary Disease (COPD).
Comparison of 18 mcg of Tiotropium Inhalation Capsules and ipratropiumMetered Dose Inhaler (2 puffs of 20 mcg, 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 tiotropium inhalation capsules (18 mcg once daily) and ipratropium MDI (2 puffs of 20 mcg q.i.d.) in patients with chronic obstructive pulmonary disease (COPD).
Read the detailed description
This is a 2-treatment, randomized, double-blind, parallel design trial in adult patient with COPD.
Each dose of tiotropium or placebo will consist of one capsule self administered from the HandiHaler device once daily during the treatment period (tiotropium or placebo). Each dose will be taken at the same time each morning between 08:00 a.m. and 10:00 a.m.
Each dose of ipratropium MDI or placebo MDI will consist of 2 puffs; patients will inhale 2 puffs four times daily. The first dose will be taken at the same time each morning between 08:00 a.m. and 10:00 a.m.; subsequent doses will be taken at lunch, at dinner and when going to bed.
Study Hypothesis:
The null hypothesis is that there is no difference in mean response between tiotropium and ipratropium.
The alternative hypothesis is that there is a difference in mean response between tiotropium and ipratropium.
Comparison(s):
This is a multi-center, randomized, double-blind, double-dummy, parallel group trial to compare the bronchodilator efficacy and safety of Tiotropium (18 mcg once a day) and ipratropium Metered Dose Inhaler (2 puffs of 18 mcg four times a day).
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Tiotropium, Ipratropium
- 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.
TiotropiumDrug
IpratropiumDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Trough FEV1 response: change from baseline FEV1 (visit 2) to visit 4 trough FEV1
Measured: 4 weeks
Secondary outcomes (11)
FEV1 (AUC0-3) response (change from baseline) for the 3 hours post drug administration
Measured: 4 weeks
Trough FVC response
Measured: 4 weeks
FVC (AUC0-3) response (as defined for FEV1)
Measured: 4 weeks
Patient questionnaire
Measured: 4 weeks
Daily PEFR
Measured: 4 weeks
Amount of rescue medication
Measured: 4 weeks
All adverse events
Measured: 4 weeks
Vital signs (pulse rate and blood pressure)
Measured: 4 weeks
Number of patients with abnormalities in routine blood chemistry, haematology and urinanalysis
Measured: 4 weeks
Changes from baseline in 12-lead electrocardiogram (ECG)
Measured: 4 weeks
Physical examination
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2006 (estimated)
- Study startJul 2002
- Primary completionMar 2003
- Study completionMar 2003
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
- 141 participants
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, B.I. Korea Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00274040
- Sponsor's protocol ID
- 205.244
- Status last verified
- Oct 2013
- First submitted
- 9 Jan 2006
- Last updated
- 1 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of 18 μg of Tiotropium Inhalation Capsules and Atrovent Metered Dose Inhaler (2 Puffs of 20 μg, 4 Times Daily) in a Double-Blind, Double-Dummy, Efficacy and Safety Study in Adults With Chronic Obstructive Pulmonary Disease (COPD).
- ClinicalTrials.gov ID
- NCT00274040
- Acronym / sponsor ID
- 205.244
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- Primary completion
- Mar 2003 (actual)
- Study completion
- Mar 2003 (actual)
- First posted
- 10 Jan 2006 (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.
Comparison of 18 mcg of Tiotropium Inhalation Capsules and ipratropiumMetered Dose Inhaler (2 puffs of 20 mcg, 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 tiotropium inhalation capsules (18 mcg once daily) and ipratropium MDI (2 puffs of 20 mcg q.i.d.) in patients with chronic obstructive pulmonary disease (COPD).
Detailed description
This is a 2-treatment, randomized, double-blind, parallel design trial in adult patient with COPD.
Each dose of tiotropium or placebo will consist of one capsule self administered from the HandiHaler device once daily during the treatment period (tiotropium or placebo). Each dose will be taken at the same time each morning between 08:00 a.m. and 10:00 a.m.
Each dose of ipratropium MDI or placebo MDI will consist of 2 puffs; patients will inhale 2 puffs four times daily. The first dose will be taken at the same time each morning between 08:00 a.m. and 10:00 a.m.; subsequent doses will be taken at lunch, at dinner and when going to bed.
Study Hypothesis:
The null hypothesis is that there is no difference in mean response between tiotropium and ipratropium.
The alternative hypothesis is that there is a difference in mean response between tiotropium and ipratropium.
Comparison(s):
This is a multi-center, randomized, double-blind, double-dummy, parallel group trial to compare the bronchodilator efficacy and safety of Tiotropium (18 mcg once a day) and ipratropium Metered Dose Inhaler (2 puffs of 18 mcg four times a day).
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 (7 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 formulas as supplied by the individual study sites."
- 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.
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 | Drug | – |
| Ipratropium | Drug | – |
Primary outcome
Trough FEV1 response: change from baseline FEV1 (visit 2) to visit 4 trough FEV1
Time frame: 4 weeks
11 secondary outcomes
FEV1 (AUC0-3) response (change from baseline) for the 3 hours post drug administration
Time frame: 4 weeks
Trough FVC response
Time frame: 4 weeks
FVC (AUC0-3) response (as defined for FEV1)
Time frame: 4 weeks
Patient questionnaire
Time frame: 4 weeks
Daily PEFR
Time frame: 4 weeks
Amount of rescue medication
Time frame: 4 weeks
All adverse events
Time frame: 4 weeks
Vital signs (pulse rate and blood pressure)
Time frame: 4 weeks
Number of patients with abnormalities in routine blood chemistry, haematology and urinanalysis
Time frame: 4 weeks
Changes from baseline in 12-lead electrocardiogram (ECG)
Time frame: 4 weeks
Physical examination
Time frame: 4 weeks
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 1 Nov 2013.
- 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
B.I. Korea Ltd.
18 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 and Ipratropium in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 18 sites in South Korea.
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 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 1 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in South Korea. 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 FEV1 (visit 2) to visit 4 trough FEV1 (time frame: 4 weeks). 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 1 Nov 2013.