Pulmonary Disease, Chronic ObstructivePhase 3NCT00281567
Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study testing Tiotropium, Respimat SMI and HandiHaler in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 2 sites in 2 countries.
Trial summary
Comparison of lung function response between tiotropium inhalation solution and 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, Respimat SMI and HandiHaler
- Type of treatment
- Medical device
- How many people
- 76 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2002to Jul 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
- Diagnosis of COPD
- FEV1 < 60% predicted
- FEV1 < 70% of FVC
- Smoking history of 10 pack-years
Who cannot join
- Significant other disease than COPD
- Recent history of MI (1 year or less)
- Cardiac arrhythmia requiring drug therapy
- History of asthma, allergic rhinitis or eosinophil count > 600 mm3
- Symptomatic prostatic hypertrophy or bladder neck obstruction
- Known narrow-angle glaucoma
Show all 12Show fewer
- Abnormal baseline hematology, blood chemistry or urinalysis
- History of cancer within last 5 years
- Life-threatening pulmonary obstruction
- Cystic fibrosis or bronchiectasis
- Tuberculosis
- Pulmonary resection
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Belgium1 site
Boehringer Ingelheim Investigational Site
Study Chairs Or Principal Investigators
Netherlands1 site
Boehringer Ingelheim Investigational Site
Study Chairs Or Principal Investigators
About this study
Official title: A Randomised, Double-blind, Double-dummy, Placebo-controlled, Crossover 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)
Comparison of lung function response between tiotropium inhalation solution and Spiriva HandiHaler.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Tiotropium, Respimat SMI, HandiHaler
- 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
Respimat SMIDevice
HandiHalerDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of trough FEV1 values at the end of 4-week treatment with tiotropium inhalation solution (5 mcg, 10 mcg) to that achieved with tiotropium inhalation powder (Spiriva 18 mcg).
Secondary outcomes (11)
Trough forced vital capacity (FVC) response after 4 weeks (change from baseline)
Measured: baseline until week 28
Peak response (FEV1 and FVC) to first dose
Measured: within 3 hours to first dose
Peak response (FEV1 and FVC) after 4 weeks
Measured: within 3 hours after 4 weeks
FEV1 AUC0-12h and FVC AUC0-12h response after 4 weeks
Measured: after 4 weeks
FEV1 AUC0-3h and FVC AUC0-3h response after the first dose and after 4 weeks
Measured: after first dose and after 4 weeks
Individual FEV1and FVC measurements at each time point
Measured: up to 28 weeks
Pre-dose morning and evening peak expiratory flow rate (PEFR) measured by patients
Measured: up to 28 weeks
Number of occasions of rescue therapy used as required (p.r.n. salbutamol)
Measured: up to 28 weeks
Median time to onset of therapeutic response after first dose
Measured: after 4 weeks
Number of patients with 15% response above baseline for each treatment at each timepoint after first dose
Measured: at week 4, 12, 20
Number of patients with 15% response above baseline for each treatment at each timepoint after 4 weeks
Measured: at week 8, 16, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2006 (estimated)
- Study startAug 2002
- Primary completionJul 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
- Crossover
- Masking
- Double blind
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, Boehringer Ingelheim KG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00281567
- Sponsor's protocol ID
- 205.250
- Status last verified
- Oct 2013
- First submitted
- 24 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 Randomised, Double-blind, Double-dummy, Placebo-controlled, Crossover 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
- NCT00281567
- Acronym / sponsor ID
- 205.250
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Aug 2002
- Primary completion
- Jul 2003 (actual)
- First posted
- 25 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 lung function response between tiotropium inhalation solution and 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 (4 listed)
- Diagnosis of COPD
- FEV1 < 60% predicted
- FEV1 < 70% of FVC
- Smoking history of 10 pack-years
Key exclusion criteria (12 listed)
- Significant other disease than COPD
- Recent history of MI (1 year or less)
- Cardiac arrhythmia requiring drug therapy
- History of asthma, allergic rhinitis or eosinophil count > 600 mm3
- Symptomatic prostatic hypertrophy or bladder neck obstruction
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 | – |
| Respimat SMI | Device | – |
| HandiHaler | Device | – |
Primary outcome
Comparison of trough FEV1 values at the end of 4-week treatment with tiotropium inhalation solution (5 mcg, 10 mcg) to that achieved with tiotropium inhalation powder (Spiriva 18 mcg).
11 secondary outcomes
Trough forced vital capacity (FVC) response after 4 weeks (change from baseline)
Time frame: baseline until week 28
Peak response (FEV1 and FVC) to first dose
Time frame: within 3 hours to first dose
Peak response (FEV1 and FVC) after 4 weeks
Time frame: within 3 hours after 4 weeks
FEV1 AUC0-12h and FVC AUC0-12h response after 4 weeks
Time frame: after 4 weeks
FEV1 AUC0-3h and FVC AUC0-3h response after the first dose and after 4 weeks
Time frame: after first dose and after 4 weeks
Individual FEV1and FVC measurements at each time point
Time frame: up to 28 weeks
Pre-dose morning and evening peak expiratory flow rate (PEFR) measured by patients
Time frame: up to 28 weeks
Number of occasions of rescue therapy used as required (p.r.n. salbutamol)
Time frame: up to 28 weeks
Median time to onset of therapeutic response after first dose
Time frame: after 4 weeks
Number of patients with 15% response above baseline for each treatment at each timepoint after first dose
Time frame: at week 4, 12, 20
Number of patients with 15% response above baseline for each treatment at each timepoint after 4 weeks
Time frame: at week 8, 16, 24
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.
Related trials for Pulmonary Disease, Chronic Obstructive
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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 KG
2 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, Respimat SMI and HandiHaler in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 2 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 4 inclusion and 12 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 2 sites in Belgium, Netherlands. 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?
Comparison of trough FEV1 values at the end of 4-week treatment with tiotropium inhalation solution (5 mcg, 10 mcg) to that achieved with tiotropium inhalation powder (Spiriva 18 mcg).. 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.