Pulmonary Disease, Chronic ObstructivePhase 3NCT00239447
Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in COPD
A Phase 3 study testing Tiotropium, HandiHaler and Respimat SMI in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 11 sites in 2 countries.
Trial summary
Non-inferiority of lung function response to Tiotropium inhalation solution compared to Spiriva HandiHaler 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, HandiHaler and Respimat SMI
- Type of treatment
- Medical device
- How many people
- 131 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 26 Nov 2002to 29 Apr 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 had to sign an informed consent consistent with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, which includes medication washout and restrictions.
- All patients had to have a diagnosis of chronic obstructive pulmonary disease.
- Patients had to have relatively stable, moderate to severe airway obstruction with an forced expiratory volume in one second (FEV1) ≤ 60% of predicted normal and FEV1 ≤ 70% of forced vital capacity FVC (Visits 1 and 2).
- Male or female patients 40 years of age or older.
- Patients had to be current or ex-smokers with a smoking history of more than 10 pack-years.
- Patients had to be able to perform technically acceptable pulmonary function tests and peak expiratory flow rate (PEFR) measurements, and had to be able to maintain records (Patient Daily Diary Card) during the study period as required in the protocol.
- Patients had to be able to inhale medication in a competent manner from the Respimat inhaler, the HandiHaler and from a metered dose inhaler (MDI).
Who cannot join
- Patients with significant diseases other than chronic obstructive pulmonary disease (COPD) had to be excluded. A significant disease was 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 relevant abnormal baseline haematology, blood chemistry, or urinalysis, if the abnormality defines a significant disease as defined in exclusion criterion No. 1.
- Patients with a recent history (i.e., one year or less) of myocardial infarction.
- Patients with any cardiac arrhythmia requiring drug therapy or who had been hospitalised for heart failure within the past three years.
- Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma were allowed.
- Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction.
Show all 9Show fewer
- Patients with known narrow-angle glaucoma.
- Patients with a history of asthma, allergic rhinitis or who have a total blood eosinophil count ≥600 mm3.
- Further exclusion criteria apply
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States10 sites
National Jewish Medical and Research Center
Denver, Colorado, 80206-2762
Division of Pulmonary and Critical Care Medicine
Little Rock, Arkansas, 72205
Minisota Lung Center
Minneapolis, Minnesota, 55407
Boehringer Ingelheim Investigational Site
San Diego, California, 92120
San Jose Clinical Research
San Jose, California, 95128
LSU MC-Sheveport
Shreveport, Louisiana, 71103
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
Boehringer Ingelheim Investigational Site
Stockton, California, 95207
Boehringer Ingelheim Investigational Site
Tacoma, Washington, 98405
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157
Canada1 site
Montreal Chest Institute - McGill University Health Centre
Montreal, Quebec, H2X 2P4
About this study
Official title: Efficacy and Safety Comparison of 4-week Treatment Periods of Two Doses [5 μg (2 Actuations of 2.5 μg) and 10 μg (2 Actuations of 5 μg)] of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Tiotropium Inhalation Powder Capsule (18μg) Delivered by the HandiHaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Non-inferiority of lung function response to Tiotropium inhalation solution compared to Spiriva HandiHaler
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Tiotropium, HandiHaler, Respimat SMI
- 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
HandiHalerDevice
Respimat SMIDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Trough FEV1 response determined at the end of each 4-week period of randomised treatment.
Measured: at the end of each 4-week period
Secondary outcomes (10)
Tiotropium plasma concentration data and urinary excretion data
Measured: at the end of each 4-week period
Trough forced vital capacity (FVC) response
Measured: after 4 weeks
Peak response (FEV1 and FVC)
Measured: within 3 hours after first dose, after 4 weeks
FEV1 AUC 0-12h and FVC AUC 0-12h response
Measured: after 4 weeks
FEV1 AUC 0-3h and FVC AUC 0-3h response
Measured: after the first dose, after 4 weeks
Individual FEV1and FVC measurements
Measured: during study course of 28 weeks
pre-dose morning and evening peak expiratory flow rate (PEFR)
Measured: during study course of 28 weeks
Number of occasions of rescue therapy used
Measured: during study course of 28 weeks
Median time to onset of therapeutic response after first dose (FEV1)
Measured: after first dose and after 4 weeks
Number of patients with 15% response above baseline for each treatment at each time point after first dose and after 4 weeks
Measured: up to 28 weeks
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 start26 Nov 2002
- Primary completion29 Apr 2004
- Study completion29 Apr 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
- Crossover
- Masking
- Double blind
- Enrolment
- 131 participants
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, Boehringer Ingelheim BV/Alkmaar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00239447
- Sponsor's protocol ID
- 205.249
- Status last verified
- Nov 2023
- First submitted
- 14 Oct 2005
- Last updated
- 1 Dec 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Comparison of 4-week Treatment Periods of Two Doses [5 μg (2 Actuations of 2.5 μg) and 10 μg (2 Actuations of 5 μg)] of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Tiotropium Inhalation Powder Capsule (18μg) Delivered by the HandiHaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT00239447
- Acronym / sponsor ID
- 205.249
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2002 (actual)
- Primary completion
- 29 Apr 2004 (actual)
- Study completion
- 29 Apr 2004 (actual)
- 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.
Non-inferiority of lung function response to Tiotropium inhalation solution compared to Spiriva HandiHaler
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 had to sign an informed consent consistent with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, which includes medication washout and restrictions.
- All patients had to have a diagnosis of chronic obstructive pulmonary disease.
- Patients had to have relatively stable, moderate to severe airway obstruction with an forced expiratory volume in one second (FEV1) ≤ 60% of predicted normal and FEV1 ≤ 70% of forced vital capacity FVC (Visits 1 and 2).
- Male or female patients 40 years of age or older.
- Patients had to be current or ex-smokers with a smoking history of more than 10 pack-years.
Key exclusion criteria (9 listed)
- Patients with significant diseases other than chronic obstructive pulmonary disease (COPD) had to be excluded. A significant disease was 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 relevant abnormal baseline haematology, blood chemistry, or urinalysis, if the abnormality defines a significant disease as defined in exclusion criterion No. 1.
- Patients with a recent history (i.e., one year or less) of myocardial infarction.
- Patients with any cardiac arrhythmia requiring drug therapy or who had been hospitalised for heart failure within the past three years.
- Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma were allowed.
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 | – |
| HandiHaler | Device | – |
| Respimat SMI | Device | – |
Primary outcome
Trough FEV1 response determined at the end of each 4-week period of randomised treatment.
Time frame: at the end of each 4-week period
10 secondary outcomes
Tiotropium plasma concentration data and urinary excretion data
Time frame: at the end of each 4-week period
Trough forced vital capacity (FVC) response
Time frame: after 4 weeks
Peak response (FEV1 and FVC)
Time frame: within 3 hours after first dose, after 4 weeks
FEV1 AUC 0-12h and FVC AUC 0-12h response
Time frame: after 4 weeks
FEV1 AUC 0-3h and FVC AUC 0-3h response
Time frame: after the first dose, after 4 weeks
Individual FEV1and FVC measurements
Time frame: during study course of 28 weeks
pre-dose morning and evening peak expiratory flow rate (PEFR)
Time frame: during study course of 28 weeks
Number of occasions of rescue therapy used
Time frame: during study course of 28 weeks
Median time to onset of therapeutic response after first dose (FEV1)
Time frame: after first dose and after 4 weeks
Number of patients with 15% response above baseline for each treatment at each time point after first dose and after 4 weeks
Time frame: up to 28 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 Dec 2023.
- 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 BV/Alkmaar
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tiotropium, HandiHaler and Respimat SMI in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 11 sites in 2 countries.
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 9 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 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Canada. 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 determined at the end of each 4-week period of randomised treatment. (time frame: at the end of each 4-week period). 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 Dec 2023.