Pulmonary Disease, Chronic ObstructivePhase 3COPDNCT02172287
Multiple Dose Comparison of Tiotropium Inhalation Capsules, Salmeterol Inhalation Aerosol and Placebo in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study testing Tiotropium (Ba679 BR) and Salmeterol in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
Trial summary
To compare the long -term (six month) bronchodilator efficacy and safety of tiotropium inhalation capsules, salmeterol inhalation aerosol and placebo in patients with COPD. A secondary objective of this study was to compare the impact of tiotropium and salmeterol on humanistic and economic health outcomes, such as… 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 (Ba679 BR) and Salmeterol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 623 participants
- Where
- No sites listed yet
- Study dates
- Feb 1999to May 2000
- 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
- Age ≥ 40 years.
- A diagnosis of relatively stable, moderate to severe COPD with:
- Screening FEV1 ≤ 60% of predicted normal value (calculated according to European Community for Coal and Steel (ECCS criteria R94- R1408) and screening FEV1 ⁄ FVC ≤ 70%).
- Smoking history ≥ 10 pack-years (a pack-year is 20 cigarettes per day for one year or equivalent).
- Ability to be trained in the proper use of the HandiHaler® device and Mahler Dyspnoea Index (MDI).
- Ability to perform all study related tests including the Shuttle Walking Test, acceptable pulmonary function tests, including Peak Expiratory Flow Rate (PEFR) measurements, and maintenance of daily diary card records.
- Ability to give written informed consent in accordance with Good Clinical Practice (GCP) and local regulations.
Who cannot join
- Clinically significant diseases other than COPD. A clinically significant disease is 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 clinically relevant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a disease listed as an exclusion criterion, will be excluded.
- All patients with a serum glutamic oxaloacetic transaminase (SGOT) > 80 IU/L, serum glutamic pyruvic transaminase (SGPT) > 80 IU/L, bilirubin > 2.0 mg/dL or creatinine > 2.0 mg/dL will be excluded regardless of clinical condition. Repeat laboratory evaluation should have not been conducted in these patients.
- A recent history (i.e., one year or less) of myocardial infarction.
- Any cardiac arrhythmia requiring drug therapy or hospitalisation for heart failure within the past three years.
- Inability to abstain from regular daytime use of oxygen therapy for more than 1 hour per day.
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- Known active tuberculosis.
- History of cancer within the last five years (excluding basal cell carcinoma).
- History of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis.
- Patients who have undergone thoracotomy with pulmonary resection.
- Any upper respiratory infection in the past six weeks prior to the screening visit or during the run-in period.
- Current participation in a pulmonary rehabilitation programme or completion of a pulmonary rehabilitation programme in the six week prior to the screening visit.
- Known hypersensitivity to anticholinergic drugs, salmeterol, or any of the components of the lactose powder capsule or MDI delivery systems.
- Known symptomatic prostatic hypertrophy or bladder neck obstruction.
- Patients with known narrow-angle glaucoma.
- Current treatment with cromolyn sodium or nedocromil sodium.
- Current treatment with antihistamines (H1 receptor antagonists).
- Oral corticosteroids medication at unstable doses (i.e. less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg prednisolone per day or 20 mg every other day.
- Current use of β-blocker medication.
- Current treatment with monoamine oxidase inhibitors of tricyclic and antidepressants.
- Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception.
- Patients with a history of asthma, allergic rhinitis or atopy or who have a total blood eosinophil count ≥ 600 mm3. A repeat eosinophil count was not permitted.
- History of and/or active significant alcohol or drug abuse.
- Concomitant or recent use of an investigational drug within one month or six half lives (whichever is greater) prior to the screening visit.
- Changes in the pulmonary therapeutic plan within the six weeks prior to the screening visit.
- Inability to comply with the medication restrictions specified in Section 4.2 of the trial protocol.
About this study
Official title: A Multiple Dose Comparison of Tiotropium Inhalation Capsules, Salmeterol Inhalation Aerosol and Placebo in a Six-Month, Double-Blind, Double-Dummy, Safety and Efficacy Study in Patients With Chronic Obstructive Pulmonary Disease (COPD)
To compare the long -term (six month) bronchodilator efficacy and safety of tiotropium inhalation capsules, salmeterol inhalation aerosol and placebo in patients with COPD. A secondary objective of this study was to compare the impact of tiotropium and salmeterol on humanistic and economic health outcomes, such as quality of life, patient preference and Health Resource Utilisation in this patient population.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Tiotropium (Ba679 BR), Salmeterol, Placebo (for Tiotropium ), Placebo (for Salmeterol)
- 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 (Ba679 BR)Drug
One capsule once daily by oral inhalation
SalmeterolDrug
Inhalation aerosol twice daily
Placebo (for Tiotropium )Drug
Placebo for Tiotropium delivered by inhalation capsule
Placebo (for Salmeterol)Drug
Placebo for Salmeterol delivered by inhalation aerosol
| Study group | Role | What they receive |
|---|---|---|
| Tiotropium (Ba679 BR) | Experimental | Tiotropium capsule once daily by oral inhalation Receives: Drug: Tiotropium (Ba679 BR); Drug: Placebo (for Salmeterol) |
| Salmeterol | Active comparator | Salmeterol inhalation aerosol twice daily Receives: Drug: Salmeterol; Drug: Placebo (for Tiotropium ) |
| Placebo | Placebo comparator | * Tiotropium (Ba679 BR)- placebo one capsule once daily by inhalation
* Salmeterol- placebo, inhalation aerosol twice daily Receives: Drug: Placebo (for Tiotropium ); Drug: Placebo (for Salmeterol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in trough Forced expiratory volume in one second (FEV1) response
Measured: baseline, up to day 169
Change from baseline in Mahler Transitional Dyspnoea Index (TDI)
Measured: baseline, up to day 169
Secondary outcomes (22)
Average Forced Expiratory Volume (FEV1) response on each test-day
Measured: 60 and 10 minutes before in-clinic dosing and at 30 minutes and 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose on day 1, 15, 57, 113 and 169
Peak Forced Expiratory Volume (FEV1) response on each test-day
Measured: 60 and 10 minutes before in-clinic dosing and at 30 minutes and 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose on day 1, 15, 57, 113 and 169
Trough Forced Vital Capacity (FVC) on each test day
Measured: 60 and 10 minutes before in-clinic dosing and at 30 minutes and 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose on day 1, 15, 57, 113 and 169
Average Forced Vital Capacity (FVC) on each test day
Measured: 60 and 10 minutes before in-clinic dosing and at 30 minutes and 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose on day 1, 15, 57, 113 and 169
Peak of Forced Vital Capacity (FVC) on each test day
Measured: 60 and 10 minutes before in-clinic dosing and at 30 minutes and 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose on day 1, 15, 57, 113 and 169
Individual FEV1 measurements at each time point
Measured: 60 and 10 minutes before in-clinic dosing and at 30 minutes and 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose on day 1, 15, 57, 113 and 169
Individual FVC measurements at each time point
Measured: 60 and 10 minutes before in-clinic dosing and at 30 minutes and 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose on day 1, 15, 57, 113 and 169
Peak Expiratory Flow Rate (PEFR) measured by the patients at home
Measured: twice daily for 29 weeks
Change from baseline in Physicians global evaluation
Measured: baseline, day 15, 57, 113, 169 and 190
Change from baseline in Chronic Obstructive Pulmonary Disease (COPD) symptom score
Measured: baseline, day 15, 57, 113, 169 and 190
Amount of rescue medication (salbutamol) therapy used during the treatment period
Measured: up to day 169
Number and length of exacerbations of COPD during the treatment period
Measured: up to day 169
Number and length of hospitalisations for respiratory disease during the treatment period
Measured: up to day 169
Change from baseline in Quality of Life measures using St. George's Respiratory Questionnaire (SGRQ)
Measured: baseline, day 57, 113, 169 and 190
Health resource utilisation beyond the study protocol
Measured: up to day 190
Change in Patient preference measures (satisfaction with COPD medication)
Measured: baseline, day 169
Change from baseline in Shuttle walking tests
Measured: baseline, day 57, 113, 169 and 190
Change from baseline in Borg dyspnea score
Measured: baseline, day 57, 113, 169 and 190
Number of patients with adverse events
Measured: up to day 190
Change from baseline Pulse rate and blood pressure
Measured: baseline, day 57, 113 and 169
Change from baseline in laboratory tests
Measured: baseline, day 169
Change from baseline in ECG
Measured: baseline, day 169
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 startFeb 1999
- Primary completionMay 2000
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
- 623 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
- NCT02172287
- Sponsor's protocol ID
- 205.130
- Acronym
- COPD
- 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
- A Multiple Dose Comparison of Tiotropium Inhalation Capsules, Salmeterol Inhalation Aerosol and Placebo in a Six-Month, Double-Blind, Double-Dummy, Safety and Efficacy Study in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT02172287
- Acronym / sponsor ID
- COPD / 205.130
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 623 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 1999
- Primary completion
- May 2000 (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.
To compare the long -term (six month) bronchodilator efficacy and safety of tiotropium inhalation capsules, salmeterol inhalation aerosol and placebo in patients with COPD. A secondary objective of this study was to compare the impact of tiotropium and salmeterol on humanistic and economic health outcomes, such as quality of life, patient preference and Health Resource Utilisation in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tiotropium (Ba679 BR) | Experimental | Drug: Tiotropium (Ba679 BR), Drug: Placebo (for Salmeterol)Tiotropium capsule once daily by oral inhalation |
| Salmeterol | Active comparator | Drug: Salmeterol, Drug: Placebo (for Tiotropium )Salmeterol inhalation aerosol twice daily |
| Placebo | Placebo comparator | Drug: Placebo (for Tiotropium ), Drug: Placebo (for Salmeterol)* Tiotropium (Ba679 BR)- placebo one capsule once daily by inhalation * Salmeterol- placebo, inhalation aerosol twice daily |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 40 years.
- A diagnosis of relatively stable, moderate to severe COPD with:
- Screening FEV1 ≤ 60% of predicted normal value (calculated according to European Community for Coal and Steel (ECCS criteria R94- R1408) and screening FEV1 ⁄ FVC ≤ 70%).
- Smoking history ≥ 10 pack-years (a pack-year is 20 cigarettes per day for one year or equivalent).
- Ability to be trained in the proper use of the HandiHaler® device and Mahler Dyspnoea Index (MDI).
Key exclusion criteria (26 listed)
- Clinically significant diseases other than COPD. A clinically significant disease is 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 clinically relevant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a disease listed as an exclusion criterion, will be excluded.
- All patients with a serum glutamic oxaloacetic transaminase (SGOT) > 80 IU/L, serum glutamic pyruvic transaminase (SGPT) > 80 IU/L, bilirubin > 2.0 mg/dL or creatinine > 2.0 mg/dL will be excluded regardless of clinical condition. Repeat laboratory evaluation should have not been conducted in these patients.
- A recent history (i.e., one year or less) of myocardial infarction.
- Any cardiac arrhythmia requiring drug therapy or hospitalisation for heart failure within the past three years.
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 (Ba679 BR)One capsule once daily by oral inhalation | Drug | Tiotropium (Ba679 BR) |
| SalmeterolInhalation aerosol twice daily | Drug | Salmeterol |
| Placebo (for Tiotropium )Placebo for Tiotropium delivered by inhalation capsule | Drug | Placebo, Salmeterol |
| Placebo (for Salmeterol)Placebo for Salmeterol delivered by inhalation aerosol | Drug | Placebo, Tiotropium (Ba679 BR) |
Primary outcome
Change from baseline in trough Forced expiratory volume in one second (FEV1) response
Time frame: baseline, up to day 169
Change from baseline in Mahler Transitional Dyspnoea Index (TDI)
Time frame: baseline, up to day 169
22 secondary outcomes
Average Forced Expiratory Volume (FEV1) response on each test-day
Time frame: 60 and 10 minutes before in-clinic dosing and at 30 minutes and 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose on day 1, 15, 57, 113 and 169
Peak Forced Expiratory Volume (FEV1) response on each test-day
Time frame: 60 and 10 minutes before in-clinic dosing and at 30 minutes and 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose on day 1, 15, 57, 113 and 169
Trough Forced Vital Capacity (FVC) on each test day
Time frame: 60 and 10 minutes before in-clinic dosing and at 30 minutes and 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose on day 1, 15, 57, 113 and 169
Average Forced Vital Capacity (FVC) on each test day
Time frame: 60 and 10 minutes before in-clinic dosing and at 30 minutes and 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose on day 1, 15, 57, 113 and 169
Peak of Forced Vital Capacity (FVC) on each test day
Time frame: 60 and 10 minutes before in-clinic dosing and at 30 minutes and 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose on day 1, 15, 57, 113 and 169
Individual FEV1 measurements at each time point
Time frame: 60 and 10 minutes before in-clinic dosing and at 30 minutes and 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose on day 1, 15, 57, 113 and 169
Individual FVC measurements at each time point
Time frame: 60 and 10 minutes before in-clinic dosing and at 30 minutes and 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose on day 1, 15, 57, 113 and 169
Peak Expiratory Flow Rate (PEFR) measured by the patients at home
Time frame: twice daily for 29 weeks
Change from baseline in Physicians global evaluation
Time frame: baseline, day 15, 57, 113, 169 and 190
Change from baseline in Chronic Obstructive Pulmonary Disease (COPD) symptom score
Time frame: baseline, day 15, 57, 113, 169 and 190
Amount of rescue medication (salbutamol) therapy used during the treatment period
Time frame: up to day 169
Number and length of exacerbations of COPD during the treatment period
Time frame: up to day 169
Number and length of hospitalisations for respiratory disease during the treatment period
Time frame: up to day 169
Change from baseline in Quality of Life measures using St. George's Respiratory Questionnaire (SGRQ)
Time frame: baseline, day 57, 113, 169 and 190
Health resource utilisation beyond the study protocol
Time frame: up to day 190
Change in Patient preference measures (satisfaction with COPD medication)
Time frame: baseline, day 169
Change from baseline in Shuttle walking tests
Time frame: baseline, day 57, 113, 169 and 190
Change from baseline in Borg dyspnea score
Time frame: baseline, day 57, 113, 169 and 190
Number of patients with adverse events
Time frame: up to day 190
Change from baseline Pulse rate and blood pressure
Time frame: baseline, day 57, 113 and 169
Change from baseline in laboratory tests
Time frame: baseline, day 169
Change from baseline in ECG
Time frame: baseline, day 169
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 (Ba679 BR) and Salmeterol 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 7 inclusion and 26 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?
Change from baseline in trough Forced expiratory volume in one second (FEV1) response (time frame: baseline, up to day 169). The study lists 2 primary outcomes in all. 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.