Pulmonary Disease, Chronic ObstructivePhase 4NCT00144196
12 Week Efficacy of Tiotropium Versus Placebo in Patients With Mild COPD According to Swedish Guidelines (SPIRIMILD)
A Phase 4 study testing tiotropium (Spiriva) in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 27 sites in Sweden.
Trial summary
To show that treatment with tiotropium inhalation capsules (18 μg q.d.) via HandiHaler® improves lung function in patients with mild COPD according to Swedish guidelines. 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 (Spiriva)
- How many people
- 224 participants
- Where
- 27 sitesSweden
- Study dates
- 11 Mar 2004to 25 Jul 2005
- Phase
- Phase 4
- 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
- Patients who have signed an written informed consent consistent with ICH GCP guidelines and local legislations prior to participation in the trial.
- Patients with a diagnosis of COPD. COPD is defined as a disease state characterised by the presence of airflow obstruction often due to chronic bronchitis or emphysema; the airflow obstruction is generally progressive, may be accompanied by airway hyperreactivity, and may be partially reversible.
- Patients 40 years of age or older without any restriction to sex.
- Patients who currently smoke or who are ex-smokers with a cigarette smoking history of >10 pack-years.
- Patients who have a relatively stable airway obstruction (at least 4 weeks free of COPD exacerbations) with a post bronchodilator FEV1 ? 60% of predicted normal, a post bronchodilation FEV1 < 70% of FVC, and a MRC symptom score minimum of 2 at Visit 1
Who cannot join
- Patients with a history of asthma, allergic rhinitis, atopy, or who have a total (absolute) blood eosinophil count ? 600 per mm3 (= 0.6 * 109/L) of the first determination at Visit 1
- Patients with known moderate or severe renal insufficiency.
- Patients with a recent history (i.e., 6 months or less prior to Visit 1) of myocardial infarction.
- Patients with any unstable or life threatening cardiac arrhythmia, including patients with a newly diagnosed, clinically relevant arrhythmia on the electrocardiogram (ECG) performed at Visit 1 as well as patients with cardiac arrhythmia requiring an intervention (i.e., hospitalisation, cardioversion, pacemaker placement, and automatic implantable cardiac defibrillator (AICD) placement) or a change in drug therapy during the last year prior to Visit 1.
- Patients who regularly use oxygen therapy.
- Patients with known active tuberculosis.
Show all 13Show fewer
- 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 clinically evident bronchiectasis.
- Patients who have undergone thoracotomy with pulmonary resection.
- Patients who are currently in a pulmonary rehabilitation program or who have completed a pulmonary rehabilitation program in the 6 weeks prior to the screening visit (Visit 1).
- Patients with known hypersensitivity to anticholinergic drugs, lactose or any other components of the inhalation capsule delivery system.
- Patients with known symptomatic hyperplasia or bladder neck obstruction. Patients being treated for prostatic hyperplasia and report minimal symptoms may be included and should continue their medications.
- Patients with known narrow-angle glaucoma.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
Sweden27 sites
Boehringer Ingelheim Investigational Site
?tvidaberg, 597 26
Boehringer Ingelheim Investigational Site
Alvesta, 342 36
Boehringer Ingelheim Investigational Site
Boden, 961 44
Boehringer Ingelheim Investigational Site
Dalum, 520 25
Boehringer Ingelheim Investigational Site
Gislaved, 332 30
Boehringer Ingelheim Investigational Site
Gothenburg, 411 53
Boehringer Ingelheim Investigational Site
Gothenburg, 416 65
Boehringer Ingelheim Investigational Site
Hässelby, 165 55
Boehringer Ingelheim Investigational Site
Helsingborg, 254 43
Boehringer Ingelheim Investigational Site
Helsingborg, 254 67
Boehringer Ingelheim Investigational Site
Höllviken, 236 51
Jakobsbergs sjukhus, Birgittavagen 4
Jarfalla, 17731
Boehringer Ingelheim Investigational Site
Kalmar, 393 50
Boehringer Ingelheim Investigational Site
Karlstad, 65224
Boehringer Ingelheim Investigational Site
Kristianstad, 291 38
Boehringer Ingelheim Investigational Site
Linköping, 581 88
Boehringer Ingelheim Investigational Site
Lule?, 971 89
KvartersAkuten, Timmermansgatan 26
Lule?, 972 31
Boehringer Ingelheim Investigational Site
Lund, 221 85
Boehringer Ingelheim Investigational Site
Motala, 591 36
Boehringer Ingelheim Investigational Site
Skärholmen, 127 37
Boehringer Ingelheim Investigational Site
Stockholm, 114 86
Halsocentralen, Hans?kervagen 1A
Stugun, 830 76
Alno V?rdcentral, Raholmsvagen 24
Sundsvall, 865 31
Boehringer Ingelheim Investigational Site
Sunne, 686 22
Boehringer Ingelheim Investigational Site
Ulricehamn, 523 26
Boehringer Ingelheim Investigational Site
Uppsala, 754 27
About this study
Official title: A 12-week Double-blind, Randomised, Parallel-group, Multi-centre Study Evaluating the Efficacy of Tiotropium Versus Placebo in Patients With Mild COPD, According to Swedish Guidelines (SPIRIMILD)
To show that treatment with tiotropium inhalation capsules (18 μg q.d.) via HandiHaler® improves lung function in patients with mild COPD according to Swedish guidelines.
Read the detailed description
Following an initial screening at the screening visit(Visit 1), patients enter a 2 week run-in period. Patients are allowed to take salbutamol (Ventoline, Diskus, 0.2 mg) prn as rescue medication and have to record their daily use of it on the Patient's Diary. Patients who meet all inclusion and none of the exclusion criteria at the check at Visit 2 will be randomised thereafter into the randomised treatment period of the study during which they will receive either tiotropium(Spiriva) or placebo in blinded fashion.
On Day 0 (Visit 2), the first administration of blinded study medication (tiotropium(Spiriva) or matching placebo) will be performed at the study site, after a pre-dose pulmonary function test (PFT) has been carried out. First administration of blinded study medication will be monitored by the investigator. Post dose PFTs will be performed at 30 min, 1 and 2 hours.
On Days 1 to 83 except Day 14, the blinded study medication will be self-administered by the patients at home. The patients will inhale one capsule (tiotropium)(Spiriva) or matching placebo) using the HandiHaler device once daily in the morning. The morning dose of the blinded study medication should be taken at approximately the same time each morning between 7:00 a.m. and 10:00 a.m.
At visit 3 and 4 PFTs will be performed predose and post dose at 30 minutes, 1 and 2 hours
Study Hypothesis:
The rationale of the study is to show that treatment with tiotropium (Spiriva) 18 ?g inhalation capsule via HandiHaler once daily improves FEV1 when compared with placebo in patients with mild COPD according to Swedish guidelines, i.e., a post-bronchodilator FEV1 < 60% of predicted normal and FEV1 < 70% of FVC.
Comparison(s):
One group will be treated with inhalation powder capsules of tiotropium (Spiriva), 18 micrograms once daily. The other group will be treated with matching placebo. Randomisation is 1:1
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- tiotropium (Spiriva)
- 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 (Spiriva)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint is defined as area under the curve of change in FEV1 from baseline for the time period from pre-dose to 2 hours post dose (AUC0 2hFEV1) after 12 weeks of randomised treatment.
Measured: week 12
Secondary outcomes (15)
Change in trough FEV1 from baseline after 12 weeks of randomized treatment
Measured: week 12
Change in trough FEV1 % of predicted after 12 weeks of randomized treatment
Measured: week 12
AUC0-2h (FEV1 % of predicted) after 12 weeks of randomized treatment
Measured: week 12
Change in trough forced vital capacity (FVC) from baseline after 12 weeks of randomized treatment
Measured: week 12
AUC0-2hFVC after 12 weeks of randomized treatment
Measured: week 12
Weekly average number of doses of rescue therapy used in the daytime, at nighttime, and total daily
Measured: week 12
Change in Baseline Dyspnea Index (BDI) scores (R96-2117)
Measured: week 12
Change in health related quality of life (HRQoL) scores according to EQ 5D (R96-2382)
Measured: week 12
Change of symptom score according to Medical Research Council (MRC) scale
Measured: week 12
Change in smoking status
Measured: week 12
Change in working status
Measured: week 12
Incidences of adverse events
Measured: week 2, 12
Pulse rate measured just before spirometry
Measured: week 2, 12
systolic blood pressure, measured just before spirometry
Measured: week 2, 12
diastolic blood pressure, measured just before spirometry
Measured: week 2, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study start11 Mar 2004
- Primary completion25 Jul 2005
- Study completion25 Jul 2005
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 224 participants
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, B.I. Sweden AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00144196
- Sponsor's protocol ID
- 205.281
- Status last verified
- Nov 2023
- First submitted
- 2 Sep 2005
- Last updated
- 5 Dec 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week Double-blind, Randomised, Parallel-group, Multi-centre Study Evaluating the Efficacy of Tiotropium Versus Placebo in Patients With Mild COPD, According to Swedish Guidelines (SPIRIMILD)
- ClinicalTrials.gov ID
- NCT00144196
- Acronym / sponsor ID
- 205.281
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2004 (actual)
- Primary completion
- 25 Jul 2005 (actual)
- Study completion
- 25 Jul 2005 (actual)
- First posted
- 5 Sep 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.
To show that treatment with tiotropium inhalation capsules (18 μg q.d.) via HandiHaler® improves lung function in patients with mild COPD according to Swedish guidelines.
Detailed description
Following an initial screening at the screening visit(Visit 1), patients enter a 2 week run-in period. Patients are allowed to take salbutamol (Ventoline, Diskus, 0.2 mg) prn as rescue medication and have to record their daily use of it on the Patient's Diary. Patients who meet all inclusion and none of the exclusion criteria at the check at Visit 2 will be randomised thereafter into the randomised treatment period of the study during which they will receive either tiotropium(Spiriva) or placebo in blinded fashion.
On Day 0 (Visit 2), the first administration of blinded study medication (tiotropium(Spiriva) or matching placebo) will be performed at the study site, after a pre-dose pulmonary function test (PFT) has been carried out. First administration of blinded study medication will be monitored by the investigator. Post dose PFTs will be performed at 30 min, 1 and 2 hours.
On Days 1 to 83 except Day 14, the blinded study medication will be self-administered by the patients at home. The patients will inhale one capsule (tiotropium)(Spiriva) or matching placebo) using the HandiHaler device once daily in the morning. The morning dose of the blinded study medication should be taken at approximately the same time each morning between 7:00 a.m. and 10:00 a.m.
At visit 3 and 4 PFTs will be performed predose and post dose at 30 minutes, 1 and 2 hours
Study Hypothesis:
The rationale of the study is to show that treatment with tiotropium (Spiriva) 18 ?g inhalation capsule via HandiHaler once daily improves FEV1 when compared with placebo in patients with mild COPD according to Swedish guidelines, i.e., a post-bronchodilator FEV1 < 60% of predicted normal and FEV1 < 70% of FVC.
Comparison(s):
One group will be treated with inhalation powder capsules of tiotropium (Spiriva), 18 micrograms once daily. The other group will be treated with matching placebo. Randomisation is 1:1
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 (5 listed)
- Patients who have signed an written informed consent consistent with ICH GCP guidelines and local legislations prior to participation in the trial.
- Patients with a diagnosis of COPD. COPD is defined as a disease state characterised by the presence of airflow obstruction often due to chronic bronchitis or emphysema; the airflow obstruction is generally progressive, may be accompanied by airway hyperreactivity, and may be partially reversible.
- Patients 40 years of age or older without any restriction to sex.
- Patients who currently smoke or who are ex-smokers with a cigarette smoking history of >10 pack-years.
- Patients who have a relatively stable airway obstruction (at least 4 weeks free of COPD exacerbations) with a post bronchodilator FEV1 ? 60% of predicted normal, a post bronchodilation FEV1 < 70% of FVC, and a MRC symptom score minimum of 2 at Visit 1
Key exclusion criteria (13 listed)
- Patients with a history of asthma, allergic rhinitis, atopy, or who have a total (absolute) blood eosinophil count ? 600 per mm3 (= 0.6 * 109/L) of the first determination at Visit 1
- Patients with known moderate or severe renal insufficiency.
- Patients with a recent history (i.e., 6 months or less prior to Visit 1) of myocardial infarction.
- Patients with any unstable or life threatening cardiac arrhythmia, including patients with a newly diagnosed, clinically relevant arrhythmia on the electrocardiogram (ECG) performed at Visit 1 as well as patients with cardiac arrhythmia requiring an intervention (i.e., hospitalisation, cardioversion, pacemaker placement, and automatic implantable cardiac defibrillator (AICD) placement) or a change in drug therapy during the last year prior to Visit 1.
- Patients who regularly use oxygen 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 (Spiriva) | Drug | – |
Primary outcome
The primary efficacy endpoint is defined as area under the curve of change in FEV1 from baseline for the time period from pre-dose to 2 hours post dose (AUC0 2hFEV1) after 12 weeks of randomised treatment.
Time frame: week 12
15 secondary outcomes
Change in trough FEV1 from baseline after 12 weeks of randomized treatment
Time frame: week 12
Change in trough FEV1 % of predicted after 12 weeks of randomized treatment
Time frame: week 12
AUC0-2h (FEV1 % of predicted) after 12 weeks of randomized treatment
Time frame: week 12
Change in trough forced vital capacity (FVC) from baseline after 12 weeks of randomized treatment
Time frame: week 12
AUC0-2hFVC after 12 weeks of randomized treatment
Time frame: week 12
Weekly average number of doses of rescue therapy used in the daytime, at nighttime, and total daily
Time frame: week 12
Change in Baseline Dyspnea Index (BDI) scores (R96-2117)
Time frame: week 12
Change in health related quality of life (HRQoL) scores according to EQ 5D (R96-2382)
Time frame: week 12
Change of symptom score according to Medical Research Council (MRC) scale
Time frame: week 12
Change in smoking status
Time frame: week 12
Change in working status
Time frame: week 12
Incidences of adverse events
Time frame: week 2, 12
Pulse rate measured just before spirometry
Time frame: week 2, 12
systolic blood pressure, measured just before spirometry
Time frame: week 2, 12
diastolic blood pressure, measured just before spirometry
Time frame: week 2, 12
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 5 Dec 2023.
- 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
B.I. Sweden AB
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tiotropium (Spiriva) in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 27 sites in Sweden.
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 5 inclusion and 13 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 5 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 27 sites in Sweden. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The primary efficacy endpoint is defined as area under the curve of change in FEV1 from baseline for the time period from pre-dose to 2 hours post dose (AUC0 2hFEV1) after 12 weeks of randomised treatment. (time frame: week 12). 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 5 Dec 2023.