Pulmonary Disease, Chronic ObstructivePhase 2NCT02175342
Pharmacodynamic and Pharmacokinetic Dose Ranging Study of Tiotropium Bromide Administered Via Respimat Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study testing Tiotropium 0.625 mcg/puff, Tiotropium 1.25 mcg/puff and Tiotropium 2.5 mcg/puff in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
Trial summary
This pharmacodynamic and pharmacokinetic dose-ranging study aims to determine the optimal dose of tiotropium inhaled as a solution from a Respimat device once a day for three weeks in patients with 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 0.625 mcg/puff, Tiotropium 1.25 mcg/puff and Tiotropium 2.5 mcg/puff
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 1998to 1 Apr 1999
- Phase
- Phase 2
- 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
- Age: ≥ 40 years;
- Diagnosis of COPD and met the following criteria:
- Relatively stable, moderate to severe airway obstruction,
- Baseline 30% ≤ FEV1 ≤ 65% of predicted normal value, predicted normal values are based on the guidelines for standardized lung function testing of the European Community for Coal and Steel (ECCS) ,
- Baseline FEV1/ forced expiratory vital capacity (FEVC) ≤ 70%;
- Smoking history ≥ 10 pack-years (p.y.). A p.y. is defined as the equivalent of smoking one pack of cigarettes per day for one year;
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- Male of female;
- Ability to be trained in the proper use of Respimat and Handihaler;
- Ability to be trained in the performance of technically satisfactory pulmonary function tests;
- Ability to provide written informed consent
- Patient affiliated to the Social Security System
Who cannot join
- History of asthma, allergic rhinitis or atopy or who have a blood eosinophil count above 600/mm³
- Changes in the therapeutic (pulmonary) plan within the last six weeks prior to the Screening Visit;
- Treatment by cromolyn/nedocromil sodium;
- Treatment by antihistamines (H1 receptor antagonists);
- A lower respiratory tract infection or any exacerbation in the past six weeks prior to the Screening Visit;
- Regular use of daytime oxygen therapy;
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- Treatment by oral corticosteroid medication if initiated or modified within the last six weeks or if daily dose > 10 mg prednisone equivalent;
- History of life threatening pulmonary obstruction, cystic fibrosis or bronchiectasis
- Patients who have undergone thoracotomy with pulmonary resection;
- History of clinically significant cardiovascular, renal neurologic, liver or endocrine dysfunction. A clinically significant disease was defined as one 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 a recent (≤ one year) history of myocardial infarction, of heart failure or patients with any cardiac arrhythmia requiring drug therapy;
- Tuberculosis with indication for treatment;
- History of cancer within the last five years. Patients with treated basal cell carcinoma were allowed:
- Current psychiatric disorders;
- Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction;
- Patients with any history of glaucoma or increased intra-ocular pressure;
- Patients with clinically significant abnormal baseline haematology or blood chemistry, if the abnormality defines a disease listed as an exclusion criterion;
- Patients with
- glutamyl-oxalo-acetic transaminase/glutamyl-pyruvic transaminase (SGOT/SGPT): > 200% of the upper limit of the normal range (ULN, )
- bilirubin: > 150% of the ULN,
- creatinine: > 125% of the ULN;
- Intolerance to aerosolised anticholinergic containing products, and/or hypersensitivity to benzalkonium chloride, to lactose or any other components of the inhalation capsule delivery system;
- Beta-blocker medication;
- Concomitant or recent (within the last month) use of investigational drugs;
- History of drug abuse and/or alcoholism;
- Pregnant or nursing women and women of childbearing potential not using a medically approved means of contraception ( urinary pregnancy test at screening);
- Previous participation in this study (i.e. having been allocated a randomised treatment number);
- Patients deprived of their freedom by a judicial or administrative decision;
- Minors, adults under guardianship;
- Persons in medical or social establishments;
- Patients in emergency situations
About this study
Official title: Pharmacodynamic and Pharmacokinetic Dose Ranging Study of Tiotropium Bromide Administered Via Respimat Device in Patients With Chronic Obstructive Pulmonary Disease (COPD): a Randomized, 3-week Multiple-dose, Placebo Controlled, Intraformulation Double-blind, Parallel Group Study
This pharmacodynamic and pharmacokinetic dose-ranging study aims to determine the optimal dose of tiotropium inhaled as a solution from a Respimat device once a day for three weeks in patients with COPD.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Tiotropium 0.625 mcg/puff, Tiotropium 1.25 mcg/puff, Tiotropium 2.5 mcg/puff, Tiotropium 5 mcg/puff, Placebo solution
- 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 0.625 mcg/puffDrug
Tiotropium 1.25 mcg/puffDrug
Tiotropium 2.5 mcg/puffDrug
Tiotropium 5 mcg/puffDrug
Placebo solutionDrug
Tiotropium-18 lactose powderDrug
Placebo lactose powderDrug
Tiotropium 10 mcg/puffDrug
RespimatDevice
HandihalerDevice
| Study group | Role | What they receive |
|---|---|---|
| Tiotropium-1.25 Respimat | Experimental | Two puffs of tiotropium inhalation solution from a Respimat device, 0.625 mcg/puff Receives: Drug: Tiotropium 0.625 mcg/puff; Device: Respimat |
| Tiotropium-2.5 Respimat | Experimental | Two puffs of tiotropium inhalation solution from a Respimat device, 1.25 mcg/puff Receives: Drug: Tiotropium 1.25 mcg/puff; Device: Respimat |
| Tiotropium-5 Respimat | Experimental | Two puffs of tiotropium inhalation solution from a Respimat device, 2.5 mcg/puff Receives: Drug: Tiotropium 2.5 mcg/puff; Device: Respimat |
| Tiotropium-10 Respimat | Experimental | Two puffs of tiotropium inhalation solution from a Respimat device, 5 mcg/puff Receives: Drug: Tiotropium 5 mcg/puff; Device: Respimat |
| Tiotropium-20 Respimat | Experimental | Two puffs of tiotropium inhalation solution from a Respimat device, 10 mcg/puff Receives: Drug: Tiotropium 10 mcg/puff; Device: Respimat |
| Placebo Respimat | Placebo comparator | Not described Receives: Drug: Placebo solution; Device: Respimat |
| Tiotropium-18 lactose powder Handihaler | Active comparator | Not described Receives: Drug: Tiotropium-18 lactose powder; Device: Handihaler |
| Placebo lactose powder Handihaler | Placebo comparator | Not described Receives: Drug: Placebo lactose powder; Device: Handihaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory volume in one second (FEV1) with emphasis on the last two hours of the 24-hour dosing interval (trough FEV1)
Measured: last two hours of the 24-hour dosing interval
Secondary outcomes (7)
Forced expiratory volume in one second (FEV1)
Measured: during the first four hours post dose
Forced Vital Capacity (FVC)
Measured: during first four hours post dose
Pharmacokinetic evaluation: 2-hours urine sampling pre- and post-dose (10 patients per group)
Measured: before and after last drug administration at day7,14 and 21.
Chronic obstructive pulmonary disease symptom scores, physician's global evaluation, sleep question and use of rescue medication
Measured: 3 weeks treatment period
Changes in ECG, pulse rate (PR) and blood pressure (BP) from the pre-dose values recorded on test day
Measured: Day 0, day 7, day 14, day 21
Changes in ECG, physical examination, haematology and biochemistry recorded before and after the trial
Measured: Screening, 24 to 28 days after treatment
Occurrence of adverse events
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study start1 Mar 1998
- Primary completion1 Apr 1999
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 202 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
- NCT02175342
- Sponsor's protocol ID
- 205.127
- Status last verified
- Jan 2025
- First submitted
- 24 Jun 2014
- Last updated
- 31 Jan 2025
- Results posted
- No
- Individual data sharing
- No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacodynamic and Pharmacokinetic Dose Ranging Study of Tiotropium Bromide Administered Via Respimat Device in Patients With Chronic Obstructive Pulmonary Disease (COPD): a Randomized, 3-week Multiple-dose, Placebo Controlled, Intraformulation Double-blind, Parallel Group Study
- ClinicalTrials.gov ID
- NCT02175342
- Acronym / sponsor ID
- 205.127
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 1998 (actual)
- Primary completion
- 1 Apr 1999 (actual)
- First posted
- 26 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.
This pharmacodynamic and pharmacokinetic dose-ranging study aims to determine the optimal dose of tiotropium inhaled as a solution from a Respimat device once a day for three weeks in patients with COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Tiotropium-1.25 Respimat | Experimental | Drug: Tiotropium 0.625 mcg/puff, Device: RespimatTwo puffs of tiotropium inhalation solution from a Respimat device, 0.625 mcg/puff |
| Tiotropium-2.5 Respimat | Experimental | Drug: Tiotropium 1.25 mcg/puff, Device: RespimatTwo puffs of tiotropium inhalation solution from a Respimat device, 1.25 mcg/puff |
| Tiotropium-5 Respimat | Experimental | Drug: Tiotropium 2.5 mcg/puff, Device: RespimatTwo puffs of tiotropium inhalation solution from a Respimat device, 2.5 mcg/puff |
| Tiotropium-10 Respimat | Experimental | Drug: Tiotropium 5 mcg/puff, Device: RespimatTwo puffs of tiotropium inhalation solution from a Respimat device, 5 mcg/puff |
| Tiotropium-20 Respimat | Experimental | Drug: Tiotropium 10 mcg/puff, Device: RespimatTwo puffs of tiotropium inhalation solution from a Respimat device, 10 mcg/puff |
| Placebo Respimat | Placebo comparator | Drug: Placebo solution, Device: Respimat |
| Tiotropium-18 lactose powder Handihaler | Active comparator | Drug: Tiotropium-18 lactose powder, Device: Handihaler |
| Placebo lactose powder Handihaler | Placebo comparator | Drug: Placebo lactose powder, Device: Handihaler |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age: ≥ 40 years;
- Diagnosis of COPD and met the following criteria:
- Smoking history ≥ 10 pack-years (p.y.). A p.y. is defined as the equivalent of smoking one pack of cigarettes per day for one year;
- Male of female;
- Ability to be trained in the proper use of Respimat and Handihaler;
Key exclusion criteria (31 listed)
- History of asthma, allergic rhinitis or atopy or who have a blood eosinophil count above 600/mm³
- Changes in the therapeutic (pulmonary) plan within the last six weeks prior to the Screening Visit;
- Treatment by cromolyn/nedocromil sodium;
- Treatment by antihistamines (H1 receptor antagonists);
- A lower respiratory tract infection or any exacerbation in the past six weeks prior to the Screening Visit;
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 0.625 mcg/puff | Drug | Tiotropium-1.25 Respimat |
| Tiotropium 1.25 mcg/puff | Drug | Tiotropium-2.5 Respimat |
| Tiotropium 2.5 mcg/puff | Drug | Tiotropium-5 Respimat |
| Tiotropium 5 mcg/puff | Drug | Tiotropium-10 Respimat |
| Placebo solution | Drug | Placebo Respimat |
| Tiotropium-18 lactose powder | Drug | Tiotropium-18 lactose powder Handihaler |
| Placebo lactose powder | Drug | Placebo lactose powder Handihaler |
| Tiotropium 10 mcg/puff | Drug | Tiotropium-20 Respimat |
| Respimat | Device | Placebo Respimat, Tiotropium-1.25 Respimat, Tiotropium-10 Respimat, Tiotropium-2.5 Respimat, Tiotropium-20 Respimat, Tiotropium-5 Respimat |
| Handihaler | Device | Placebo lactose powder Handihaler, Tiotropium-18 lactose powder Handihaler |
Primary outcome
Forced expiratory volume in one second (FEV1) with emphasis on the last two hours of the 24-hour dosing interval (trough FEV1)
Time frame: last two hours of the 24-hour dosing interval
7 secondary outcomes
Forced expiratory volume in one second (FEV1)
Time frame: during the first four hours post dose
Forced Vital Capacity (FVC)
Time frame: during first four hours post dose
Pharmacokinetic evaluation: 2-hours urine sampling pre- and post-dose (10 patients per group)
Time frame: before and after last drug administration at day7,14 and 21.
Chronic obstructive pulmonary disease symptom scores, physician's global evaluation, sleep question and use of rescue medication
Time frame: 3 weeks treatment period
Changes in ECG, pulse rate (PR) and blood pressure (BP) from the pre-dose values recorded on test day
Time frame: Day 0, day 7, day 14, day 21
Changes in ECG, physical examination, haematology and biochemistry recorded before and after the trial
Time frame: Screening, 24 to 28 days after treatment
Occurrence of adverse events
Time frame: up to 28 days
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 31 Jan 2025.
- Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
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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 2 study testing Tiotropium 0.625 mcg/puff, Tiotropium 1.25 mcg/puff and Tiotropium 2.5 mcg/puff 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 11 inclusion and 31 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 31 Jan 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Forced expiratory volume in one second (FEV1) with emphasis on the last two hours of the 24-hour dosing interval (trough FEV1) (time frame: last two hours of the 24-hour dosing interval). 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 31 Jan 2025.