Pulmonary Disease, Chronic ObstructivePhase 3NCT02172378
12-week Treatment With Inhaled Tiotropium (18 mcg Once Daily) on Lung Function and Static Lung Volumes in Stable, Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Patients. Correlation to Dyspnoea Scales
A Phase 3 study testing Tiotropium inhalation capsules in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
Trial summary
Determine the effect of 12-week treatment with inhaled tiotropium bromide on lung function and static lung volumes, correlate this effect with dyspnoea in COPD patients. 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 capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- May 2000to Jan 2002
- 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
- Male or female patients 40 years of age or older.
- All patients had to have a diagnosis of COPD and had to meet the following spirometric and static lung volume criteria:
- Patients had to have relatively stable, moderate to severe airway obstruction with:
- FEV1 ≤ 50 % of predicted value,
- FEV1/SVC ≤ 70 %.
- All patients had to have the presence of lung hyperinflation as demonstrated by RV ≥ 125 % of predicted value.
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- Predicted normal values were calculated according to European Community Coal and Steel (ECCS)
- Males:
- FEV1 predicted (L) = 4.30 x height (metres) - 0.029 x age (years) - 2.49
- RV predicted (L) = 1.31 x height (metres) + 0.022 x age (years) - 1.23
- Females:
- FEV1 predicted (L) = 3.95 x height (metres) - 0.025 x age (years) - 2.60
- RV predicted (L) = 1.81 x height (metres) - 0.016 x age (years) - 2.00
- Patients had to be current or ex-smokers with a smoking history of more than 10 pack-years (p.y.). Patients who never smoked cigarettes were excluded.
- Number of p.y. = Number of cigarettes/day / 20 x years of smoking
- Patients had to be able to perform all study related tests including the SWT, acceptable pulmonary function tests including PEFR measurements, and had to be able to maintain records during the study period as required in the protocol.
- Patients had to be able to inhale medication from the HandiHaler.
- All patients had to sign an informed consent form prior to participation in the trial i.e. prior to pre-study washout of their usual pulmonary medication.
- Eosinophilia < 600/mm³ documented in the past year (if not available, a blood count cell was performed).
Who cannot join
- Patients with a history of asthma, allergic rhinitis or atopy.
- Patients with significant diseases other than COPD were excluded. A significant disease was defined as a disease which in the opinion of the investigator may have either put the patient at risk because of participation in the study or a disease which may have influenced the results of the study or the patient's ability to participate in the study.
- 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, pulmonary oedema, or patients with cardiac arrhythmia requiring drug therapy.
- Patients who regularly used daytime oxygen therapy for more than one hour per day and in the investigator.s opinion was unable to abstain from the use of oxygen therapy.
- Patients with known active tuberculosis.
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- Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma were allowed.
- Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis.
- Patients who underwent thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reason were evaluated as per exclusion criterion No. 2.
- Patients with lower respiratory tract infection in the past six weeks prior to the Screening Visit (Visit 1) or during the run-in period.
- Patients who were currently in a pulmonary rehabilitation programme or who completed a pulmonary rehabilitation programme in the six 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 prostatic hypertrophy or bladder neck obstruction.
- Patients with known narrow-angle glaucoma.
- Patients who were treated with β-blockers, cromolyn sodium or nedocromil.
- Patients who were treated with antihistamines (H1 receptor antagonists) or antileukotrienes.
- Patients who were treated with monoamine oxidase inhibitors or tricyclic antidepressants.
- Patients using oral corticosteroid medication at unstable doses (i.e. less than six weeks on a stable dose) or at a dose in excess of the equivalent of 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 (i.e. oral contraceptives, intra-uterine devices, diaphragm or subdermal implants).
- Patients with history and/or active significant alcohol or drug abuse.
- Patients who took another investigational drug within one month or ten half lives (whichever was greater) prior to Visit 1.
About this study
Official title: Effect of a 12-week Treatment With Inhaled Tiotropium (18 mcg Once Daily) on Lung Function and Static Lung Volumes in Stable, Moderate to Severe COPD Patients. Correlation to Dyspnoea Scales. A Double-blind, Placebo-controlled, Randomized, Parallel Group Study
Determine the effect of 12-week treatment with inhaled tiotropium bromide on lung function and static lung volumes, correlate this effect with dyspnoea in COPD patients.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Tiotropium inhalation capsules, Placebo inhalation capsules
- 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 capsulesDrug
Placebo inhalation capsulesDrug
| Study group | Role | What they receive |
|---|---|---|
| Tiotropium inhalation capsules | Experimental | Not described Receives: Drug: Tiotropium inhalation capsules |
| Placebo inhalation capsules | Placebo comparator | Not described Receives: Drug: Placebo inhalation capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
trough FVC response at the end of the 12-week study
Measured: after 12 weeks of treatment (day 84)
Secondary outcomes (24)
Determination of breathlessness (dyspnoea) as measured by the modified Borg scale
Measured: Screening, day 0, day 42, day 84
Evaluation of the Expiratory Flow Limitation (EFL) using the Negative Expiratory Pressure (NEP) method (optional)
Measured: Screening, day 0, day 42, day 84
Evaluation of inspiratory capacity (IC)
Measured: Screening, day 0, day 42, day 84, day 98
Evaluation of slow vital capacity (SVC)
Measured: Screening, day 0, day 42, day 84, day 98
Evaluation of FEV1 (Forced expiratory volume in one second)
Measured: Screening, day 0, day 42, day 84, day 98
Evaluation of FVC (Forced vital capacity)
Measured: Screening, day 0, day 42, day 84, day 98
Evaluation of FEF25-75% (Forced Expiratory Flow, mid expiratory phase)
Measured: Screening, day 0, day 42, day 84, day 98
Evaluation of FEF50% (Forced Expiratory Flow, at 50% of FVC)
Measured: Screening, day 0, day 42, day 84, day 98
Evaluation of FEF75% (Forced Expiratory Flow, at 75% of FVC)
Measured: Screening, day 0, day 42, day 84, day 98
Evaluation of thoracic gas volume (TGV)
Measured: Screening, day 0, day 42, day 84, day 98
Evaluation of dyspnoea by Baseline Dyspnoea index (BDI)/Transition Dyspnoea index (TDI)
Measured: Day 0, day 42, day 84
Evaluation of physician's global assessment
Measured: Day 0 (60 min. before dosing), day 42, day 84
Evaluation of COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest)
Measured: Day 0 (60 min before dosing), day 42, day 84
Amount of salbutamol therapy used during the trial period
Measured: 16 week evaluation period
Peak expiratory flow rate (PEFR) measured by the patients at home twice daily
Measured: 16 week evaluation period
Evaluation of Saint George's hospital respiratory questionnaire (SGRQ)
Measured: Day 0 (60 min. before dosing), day 42, day 84
Evaluation of Shuttle Walking test (SWT)
Measured: Screening, Day 0, day 42, 84
Occurence of adverse events
Measured: up to 14 weeks after treatment
Change from baseline in pulse rate (PR) in conjunction with spirometry at clinic visits
Measured: 16 weeks evaluation period
Change from baseline in blood pressure (BP) in conjunction with spirometry at clinic visits
Measured: 16 week evaluation period
Evaluation of total lung capacity (TLC)
Measured: Screening, day 0, day 42, day 84, day 98
Evaluation of flow resistance in the airways (Raw)
Measured: Screening, day 0, day 42, day 84, day 98
Evaluation of conductance of the airways (SGaw)
Measured: Screening, day 0, day 42, day 84, day 98
Evaluation of residual volume (RV)
Measured: Screening, day 0, day 42, day 84, day 98
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startMay 2000
- Primary completionJan 2002
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
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02172378
- Sponsor's protocol ID
- 205.215
- Status last verified
- Jun 2014
- First submitted
- 20 Jun 2014
- Last updated
- 24 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a 12-week Treatment With Inhaled Tiotropium (18 mcg Once Daily) on Lung Function and Static Lung Volumes in Stable, Moderate to Severe COPD Patients. Correlation to Dyspnoea Scales. A Double-blind, Placebo-controlled, Randomized, Parallel Group Study
- ClinicalTrials.gov ID
- NCT02172378
- Acronym / sponsor ID
- 205.215
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2000
- Primary completion
- Jan 2002 (actual)
- First posted
- 24 Jun 2014 (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.
Determine the effect of 12-week treatment with inhaled tiotropium bromide on lung function and static lung volumes, correlate this effect with dyspnoea in COPD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tiotropium inhalation capsules | Experimental | Drug: Tiotropium inhalation capsules |
| Placebo inhalation capsules | Placebo comparator | Drug: Placebo inhalation capsules |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Male or female patients 40 years of age or older.
- All patients had to have a diagnosis of COPD and had to meet the following spirometric and static lung volume criteria:
- Predicted normal values were calculated according to European Community Coal and Steel (ECCS)
- Patients had to be current or ex-smokers with a smoking history of more than 10 pack-years (p.y.). Patients who never smoked cigarettes were excluded.
- Number of p.y. = Number of cigarettes/day / 20 x years of smoking
Key exclusion criteria (21 listed)
- Patients with a history of asthma, allergic rhinitis or atopy.
- Patients with significant diseases other than COPD were excluded. A significant disease was defined as a disease which in the opinion of the investigator may have either put the patient at risk because of participation in the study or a disease which may have influenced the results of the study or the patient's ability to participate in the study.
- 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, pulmonary oedema, or patients with cardiac arrhythmia requiring drug therapy.
- Patients who regularly used daytime oxygen therapy for more than one hour per day and in the investigator.s opinion was unable to abstain from the use of 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 inhalation capsules | Drug | Tiotropium inhalation capsules |
| Placebo inhalation capsules | Drug | Placebo inhalation capsules |
Primary outcome
trough FVC response at the end of the 12-week study
Time frame: after 12 weeks of treatment (day 84)
24 secondary outcomes
Determination of breathlessness (dyspnoea) as measured by the modified Borg scale
Time frame: Screening, day 0, day 42, day 84
Evaluation of the Expiratory Flow Limitation (EFL) using the Negative Expiratory Pressure (NEP) method (optional)
Time frame: Screening, day 0, day 42, day 84
Evaluation of inspiratory capacity (IC)
Time frame: Screening, day 0, day 42, day 84, day 98
Evaluation of slow vital capacity (SVC)
Time frame: Screening, day 0, day 42, day 84, day 98
Evaluation of FEV1 (Forced expiratory volume in one second)
Time frame: Screening, day 0, day 42, day 84, day 98
Evaluation of FVC (Forced vital capacity)
Time frame: Screening, day 0, day 42, day 84, day 98
Evaluation of FEF25-75% (Forced Expiratory Flow, mid expiratory phase)
Time frame: Screening, day 0, day 42, day 84, day 98
Evaluation of FEF50% (Forced Expiratory Flow, at 50% of FVC)
Time frame: Screening, day 0, day 42, day 84, day 98
Evaluation of FEF75% (Forced Expiratory Flow, at 75% of FVC)
Time frame: Screening, day 0, day 42, day 84, day 98
Evaluation of thoracic gas volume (TGV)
Time frame: Screening, day 0, day 42, day 84, day 98
Evaluation of dyspnoea by Baseline Dyspnoea index (BDI)/Transition Dyspnoea index (TDI)
Time frame: Day 0, day 42, day 84
Evaluation of physician's global assessment
Time frame: Day 0 (60 min. before dosing), day 42, day 84
Evaluation of COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest)
Time frame: Day 0 (60 min before dosing), day 42, day 84
Amount of salbutamol therapy used during the trial period
Time frame: 16 week evaluation period
Peak expiratory flow rate (PEFR) measured by the patients at home twice daily
Time frame: 16 week evaluation period
Evaluation of Saint George's hospital respiratory questionnaire (SGRQ)
Time frame: Day 0 (60 min. before dosing), day 42, day 84
Evaluation of Shuttle Walking test (SWT)
Time frame: Screening, Day 0, day 42, 84
Occurence of adverse events
Time frame: up to 14 weeks after treatment
Change from baseline in pulse rate (PR) in conjunction with spirometry at clinic visits
Time frame: 16 weeks evaluation period
Change from baseline in blood pressure (BP) in conjunction with spirometry at clinic visits
Time frame: 16 week evaluation period
Evaluation of total lung capacity (TLC)
Time frame: Screening, day 0, day 42, day 84, day 98
Evaluation of flow resistance in the airways (Raw)
Time frame: Screening, day 0, day 42, day 84, day 98
Evaluation of conductance of the airways (SGaw)
Time frame: Screening, day 0, day 42, day 84, day 98
Evaluation of residual volume (RV)
Time frame: Screening, day 0, day 42, day 84, day 98
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 24 Jun 2014.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tiotropium inhalation capsules in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
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 19 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 24 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 FVC response at the end of the 12-week study (time frame: after 12 weeks of treatment (day 84)). 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 24 Jun 2014.