Pulmonary Disease, Chronic ObstructivePhase 3NCT02173691
Efficacy and Safety of Tiotropium Compared to Salmeterol and Placebo in Patients With Chronic Obstructive Bronchitis (COPD)
A Phase 3 study testing Tiotropium inhalation powder capsules and Salmeterol inhalation aerosol in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
Trial summary
The objective of this study is to compare the long-term (six month) bronchodilator efficacy and safety of tiotropium inhalation capsules, salmeterol inhalation aerosol and placebo inpatients 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 inhalation powder capsules and Salmeterol inhalation aerosol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 584 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 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 Metered Dose Inhaler (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 diary card records.
- Ability to give written informed consent in accordance with Good Clinical Practice and local regulations.
Who cannot join
- Clinically significant diseases other than COPD.
- 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.
- 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 corticosteroid 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 of prednisolone per day or 20 mg every other day.
- Current use of β-blocker medication.
- Current treatment with monoamine oxidase inhibitors or tricyclic 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 > 600mm3.
- 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)
The objective of this study is to compare the long-term (six month) bronchodilator efficacy and safety of tiotropium inhalation capsules, salmeterol inhalation aerosol and placebo inpatients with COPD.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Tiotropium inhalation powder capsules, Salmeterol inhalation aerosol, Placebo inhalation aerosol, Placebo inhalation powder 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 powder capsulesDrug
Salmeterol inhalation aerosolDrug
Placebo inhalation aerosolDrug
Placebo inhalation powder capsulesDrug
| Study group | Role | What they receive |
|---|---|---|
| Tiotropium | Experimental | Not described Receives: Drug: Tiotropium inhalation powder capsules; Drug: Placebo inhalation aerosol |
| Salmeterol | Active comparator | Not described Receives: Drug: Salmeterol inhalation aerosol; Drug: Placebo inhalation powder capsules |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo inhalation aerosol; Drug: Placebo inhalation powder capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trough forced expiratory volume in one second (FEV1) response
Measured: 6 months
Transition Dyspnoea Index (TDI) focal score
Measured: 6 months
Secondary outcomes (22)
Average FEV1 response
Measured: 30 and 60 min prior to and 30 and 60 min, 2 and 3 h post treatment on day 1, week 2, 8, 16, 24
Peak FEV1 response
Measured: 30 and 60 min prior to and 30 and 60 min, 2 and 3 h post treatment on day 1, week 2, 8, 16, 24
Trough FVC (forced vital capacity) response
Measured: 30 and 60 min prior to and 30 and 60 min, 2 and 3 h post treatment on day 1, week 2, 8, 16, 24
Average FVC (forced vital capacity) response
Measured: 30 and 60 min prior to and 30 and 60 min, 2 and 3 h post treatment on day 1, week 2, 8, 16, 24
Peak FVC (forced vital capacity) response
Measured: 30 and 60 min prior to and 30 and 60 min, 2 and 3 h post treatment on day 1, week 2, 8, 16, 24
Individual FEV1 measurement
Measured: Day 1, weeks 2, 8, 16, 24
Individual FVC measurement
Measured: Day 1, weeks 2, 8, 16, 24
Patient peak expiratory flow rates (PEFR) twice daily
Measured: 27 weeks
Physician's global evaluation on an 8-point-scale
Measured: 27 weeks
COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest)
Measured: 27 weeks
Amount of salbutamol therapy used during the treatment period
Measured: 27 weeks
Number and length of exacerbations of COPD
Measured: 27 weeks
Number and length of hospitalizations for respiratory disease
Measured: 27 weeks
Changes from baseline in St. George's Hospital Respiratory Questionnaire (SGRQ)
Measured: Day 1, week 8, 16, 24 and 27
Changes from baseline in Mahler Dyspnoea Index (Baseline Dyspnoea Index /Transitional Dyspnoea Index (BDI/TDI))
Measured: Baseline, week 8, 16, 24, 27
Health resource utilisation
Measured: 27 weeks
Patient preference measures
patient satisfaction questionnaire score
Measured: Day 1 and week 24
Changes from baseline in Shuttle walking tests (SWT) and Borg dyspnea score
Measured: Day 1, week 8, 16, 24, 27
Occurrence of Adverse Events
Measured: 27 weeks
Changes from baseline in pulse rate and blood pressure in conjunction with spirometry
Measured: baseline, Day 1, week 2, 8, 16 and 24
Changes from baseline in physical examination and ECG
Measured: baseline and week 24
Changes from baseline in laboratory tests
Measured: baseline and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 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
- Who is masked
- Participant, Investigator
- Enrolment
- 584 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
- NCT02173691
- Sponsor's protocol ID
- 205.137
- Status last verified
- Jun 2014
- First submitted
- 20 Jun 2014
- Last updated
- 26 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 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
- NCT02173691
- Acronym / sponsor ID
- 205.137
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 584 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 1999
- Primary completion
- May 2000 (actual)
- First posted
- 25 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.
The objective of this study is to compare the long-term (six month) bronchodilator efficacy and safety of tiotropium inhalation capsules, salmeterol inhalation aerosol and placebo inpatients with COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tiotropium | Experimental | Drug: Tiotropium inhalation powder capsules, Drug: Placebo inhalation aerosol |
| Salmeterol | Active comparator | Drug: Salmeterol inhalation aerosol, Drug: Placebo inhalation powder capsules |
| Placebo | Placebo comparator | Drug: Placebo inhalation aerosol, Drug: Placebo inhalation powder capsules |
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:
- 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 Metered Dose Inhaler (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 diary card records.
Key exclusion criteria (26 listed)
- Clinically significant diseases other than COPD.
- 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.
- 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 inhalation powder capsules | Drug | Tiotropium |
| Salmeterol inhalation aerosol | Drug | Salmeterol |
| Placebo inhalation aerosol | Drug | Placebo, Tiotropium |
| Placebo inhalation powder capsules | Drug | Placebo, Salmeterol |
Primary outcome
Trough forced expiratory volume in one second (FEV1) response
Time frame: 6 months
Transition Dyspnoea Index (TDI) focal score
Time frame: 6 months
22 secondary outcomes
Average FEV1 response
Time frame: 30 and 60 min prior to and 30 and 60 min, 2 and 3 h post treatment on day 1, week 2, 8, 16, 24
Peak FEV1 response
Time frame: 30 and 60 min prior to and 30 and 60 min, 2 and 3 h post treatment on day 1, week 2, 8, 16, 24
Trough FVC (forced vital capacity) response
Time frame: 30 and 60 min prior to and 30 and 60 min, 2 and 3 h post treatment on day 1, week 2, 8, 16, 24
Average FVC (forced vital capacity) response
Time frame: 30 and 60 min prior to and 30 and 60 min, 2 and 3 h post treatment on day 1, week 2, 8, 16, 24
Peak FVC (forced vital capacity) response
Time frame: 30 and 60 min prior to and 30 and 60 min, 2 and 3 h post treatment on day 1, week 2, 8, 16, 24
Individual FEV1 measurement
Time frame: Day 1, weeks 2, 8, 16, 24
Individual FVC measurement
Time frame: Day 1, weeks 2, 8, 16, 24
Patient peak expiratory flow rates (PEFR) twice daily
Time frame: 27 weeks
Physician's global evaluation on an 8-point-scale
Time frame: 27 weeks
COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest)
Time frame: 27 weeks
Amount of salbutamol therapy used during the treatment period
Time frame: 27 weeks
Number and length of exacerbations of COPD
Time frame: 27 weeks
Number and length of hospitalizations for respiratory disease
Time frame: 27 weeks
Changes from baseline in St. George's Hospital Respiratory Questionnaire (SGRQ)
Time frame: Day 1, week 8, 16, 24 and 27
Changes from baseline in Mahler Dyspnoea Index (Baseline Dyspnoea Index /Transitional Dyspnoea Index (BDI/TDI))
Time frame: Baseline, week 8, 16, 24, 27
Health resource utilisation
Time frame: 27 weeks
Patient preference measures
Time frame: Day 1 and week 24
Changes from baseline in Shuttle walking tests (SWT) and Borg dyspnea score
Time frame: Day 1, week 8, 16, 24, 27
Occurrence of Adverse Events
Time frame: 27 weeks
Changes from baseline in pulse rate and blood pressure in conjunction with spirometry
Time frame: baseline, Day 1, week 2, 8, 16 and 24
Changes from baseline in physical examination and ECG
Time frame: baseline and week 24
Changes from baseline in laboratory tests
Time frame: baseline and week 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 26 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 powder capsules and Salmeterol inhalation aerosol 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 26 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 forced expiratory volume in one second (FEV1) response (time frame: 6 months). 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 26 Jun 2014.