Pulmonary Disease, Chronic ObstructivePhase 3NCT02172794
Tiotropium Inhalation Capsules and Salmeterol Inhalation Aerosol on Muscular Efficiency and Resting Energy Expenditure (REE) in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study testing Tiotropium and Salmeterol in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
Trial summary
The primary objective of this study is to evaluate the effect of tiotropium on gross muscular efficiency 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 and Salmeterol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- May 2002to Oct 2005
- 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
- All patients had to sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions.
- Male or female patients 40 years of age or older.
- All patients had to have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
- Patients had to have moderate to severe airway obstruction with a postbronchodilator FEV1/FVC ≤ 70% and FEV1 ≤ 60% predicted (Visit 1).
- FEV1 % predicted and/or forced vital capacity (FVC) increases >5% after inhalation with 480 μg salbutamol and 80 μg ipratropium
- Patients had to be current or ex-smokers with a smoking history of more than 10 pack-years.
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- Patients had to be able to perform technically acceptable pulmonary function tests and had to be able to maintain records (Patient Daily Record) during the study period as required in the protocol.
- Patients had to be able to inhale medication from the HandiHaler, and from an inhalation aerosol.
- Patients should have had a ventilatory limitation of maximal exercise capacity:
- Increase in arterial carvon dioxide tension (PaCO2) during incremental bicycle test and/or increase in minute ventilation (VE) max > 80% (FEV1 x 37.5)
- Patients should have had a Wmax ≥ 40 Watt during maximal incremental bicycle test.
Who cannot join
- Increase of blood lactate > 10 mmol/L at peak exercise
- Increase of blood lactate >2.5 mmol/L at ≥ 50% of Wmax
- Decrease of oxygen saturation below 90% at ≥ 50% of Wmax
- Patients with significant diseases other than COPD had to be excluded. A significant disease was defined as a disease 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 haemoglobulin, leukocytes, thrombocytes, glucose, sodium, potassium.
- Patients with a recent history (i.e., six months or less) of myocardial infarction.
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- Patients with any cardiac arrhythmia requiring drug therapy or who have been hospitalised for heart failure within the past three years.
- Patients with known active tuberculosis.
- Patients on oxygen therapy.
- Patients with a history of cystic fibrosis, bronchiectasis, interstitial lung disease, or pulmonary thromboembolic disease.
- Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion 4.
- Patients with any respiratory infection in the six weeks prior to the Screening Visit (Visit 1) or during the baseline period. The enrolment of these patients was to be postponed for at least six weeks.
- Patients who have frequent exacerbations (at least three in the preceding year) which could be expected to interfere with the patient's ability to participate in the trial should be excluded.
- Patients with known hypersensitivity to anticholinergic drugs, beta adrenergics, lactose or any other components of the inhalation capsule delivery system.
- Patients with a history of cancer within the last three years. Patients with treated basal cell carcinoma were allowed. Patients with successfully treated cancers greater than five years prior to entry were allowed.
- Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction.
- Patients with known narrow-angle glaucoma.
- Patients who were being treated with cromolyn sodium or nedocromil sodium.
- Patients who were being treated with antihistamines (H1 receptor antagonists).
- Patients who were being treated with theophyllines
- Patients who were currently on β-blocker therapy.
- Patients using 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 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 for the previous 3 months (i.e. oral contraceptives, intrauterine devices, diaphragm or subdermal implants e.g. Norplant).
- Patients with a history of asthma or allergic rhinitis or who have a total blood eosinophil count ≥600 /mm3. A repeat eosinophil count was not conducted in these patients (Criterion modified by Protocol Amendment 2).
- Patients with significant alcohol or drug abuse within the past two years.
- Patients who had taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit (Visit 1).
About this study
Official title: A Randomised, Double-Blind, Double-Dummy, Placebo-Controlled, Crossover Comparison of the Effect of 6-Week Treatment Periods of Tiotropium Inhalation Capsules (18 μg) and Salmeterol Inhalation Aerosol on Muscular Efficiency and Resting Energy Expenditure (REE) in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD).
The primary objective of this study is to evaluate the effect of tiotropium on gross muscular efficiency
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Tiotropium, Placebo to tiotropium, Salmeterol, Placebo to 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.
TiotropiumDrug
Placebo to tiotropiumDrug
SalmeterolDrug
Placebo to salmeterolDrug
| Study group | Role | What they receive |
|---|---|---|
| tiotropium | Experimental | Not described Receives: Drug: Tiotropium; Drug: Placebo to tiotropium |
| salmeterol | Active comparator | Not described Receives: Drug: Salmeterol; Drug: Placebo to salmeterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bruto muscular efficiency by one-point measurement of energy expenditure (EE) during bicycling at 50% Wmax
Measured: Day 42, 84, 126
Secondary outcomes (11)
Resting energy expenditure (REE)
Measured: Day 42, 84, 126
Endurance capacity in minutes
Measured: Day 42, 84, 126
Nett muscular efficiency (%)
Measured: Day 42, 84, 126
Forced expiratory volume in one second (FEV1)
Measured: Up to day 140
Peak expiratory flow (PEF) variability
Measured: Up to day 140
Specific airway conductance (sGaw)
Measured: Day 42, 84, 126
Functional residual capacity (FRC)
Measured: Day 42, 84, 126
COPD Control Questionnaire (CCQ) scores on a 7 point scale
Measured: Day 42, 84, 126
Number of Participants with Adverse Events
Measured: up to day 140
Change from baseline in pulse rate
Measured: Baseline, up to day 140
Change from baseline in blood pressure
Measured: Baseline, up to day 140
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 2002
- Primary completionOct 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 48 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
- NCT02172794
- Sponsor's protocol ID
- 205.261
- Status last verified
- Aug 2018
- First submitted
- 20 Jun 2014
- Last updated
- 31 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind, Double-Dummy, Placebo-Controlled, Crossover Comparison of the Effect of 6-Week Treatment Periods of Tiotropium Inhalation Capsules (18 μg) and Salmeterol Inhalation Aerosol on Muscular Efficiency and Resting Energy Expenditure (REE) in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD).
- ClinicalTrials.gov ID
- NCT02172794
- Acronym / sponsor ID
- 205.261
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2002
- Primary completion
- Oct 2005 (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.
The primary objective of this study is to evaluate the effect of tiotropium on gross muscular efficiency
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tiotropium | Experimental | Drug: Tiotropium, Drug: Placebo to tiotropium |
| salmeterol | Active comparator | Drug: Salmeterol, Drug: Placebo to salmeterol |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- All patients had to sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions.
- Male or female patients 40 years of age or older.
- All patients had to have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
- Patients had to have moderate to severe airway obstruction with a postbronchodilator FEV1/FVC ≤ 70% and FEV1 ≤ 60% predicted (Visit 1).
- FEV1 % predicted and/or forced vital capacity (FVC) increases >5% after inhalation with 480 μg salbutamol and 80 μg ipratropium
Key exclusion criteria (26 listed)
- Increase of blood lactate > 10 mmol/L at peak exercise
- Increase of blood lactate >2.5 mmol/L at ≥ 50% of Wmax
- Decrease of oxygen saturation below 90% at ≥ 50% of Wmax
- Patients with significant diseases other than COPD had to be excluded. A significant disease was defined as a disease 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 haemoglobulin, leukocytes, thrombocytes, glucose, sodium, potassium.
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 | Drug | tiotropium |
| Placebo to tiotropium | Drug | tiotropium |
| Salmeterol | Drug | salmeterol |
| Placebo to salmeterol | Drug | salmeterol |
Primary outcome
Bruto muscular efficiency by one-point measurement of energy expenditure (EE) during bicycling at 50% Wmax
Time frame: Day 42, 84, 126
11 secondary outcomes
Resting energy expenditure (REE)
Time frame: Day 42, 84, 126
Endurance capacity in minutes
Time frame: Day 42, 84, 126
Nett muscular efficiency (%)
Time frame: Day 42, 84, 126
Forced expiratory volume in one second (FEV1)
Time frame: Up to day 140
Peak expiratory flow (PEF) variability
Time frame: Up to day 140
Specific airway conductance (sGaw)
Time frame: Day 42, 84, 126
Functional residual capacity (FRC)
Time frame: Day 42, 84, 126
COPD Control Questionnaire (CCQ) scores on a 7 point scale
Time frame: Day 42, 84, 126
Number of Participants with Adverse Events
Time frame: up to day 140
Change from baseline in pulse rate
Time frame: Baseline, up to day 140
Change from baseline in blood pressure
Time frame: Baseline, up to day 140
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 Aug 2018.
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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 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 11 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 31 Aug 2018. 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. 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?
Bruto muscular efficiency by one-point measurement of energy expenditure (EE) during bicycling at 50% Wmax (time frame: Day 42, 84, 126). 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 Aug 2018.