Pulmonary Disease, Chronic ObstructivePhase 3NCT02172469
Efficacy and Safety of Tiotropium and Atrovent in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study testing Tiotropium inhalation powder capsule and Ipratropium Bromide Metered Dose Inhaler in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
Trial summary
To compare the bronchodilator efficacy and safety of tiotropium inhalation capsules (18 µg once daily) and Atrovent® MDI (2 puffs of 20µg q.i.d.) among Filipino 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 inhalation powder capsule and Ipratropium Bromide Metered Dose Inhaler
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 215 participants
- Where
- No sites listed yet
- Study dates
- May 2001to Apr 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
- All patients had a diagnosis of chronic obstructive pulmonary disease according to the following criteria:
- Patients had relatively stable airway obstruction with an FEV1 less than or equal to 65% of predicted normal and FEV1 less than or equal to 70% of FVC.
- Predicted normal values were based on the guidelines for standardised lung function testing in the Philippines.
- Male or female patients 40 years of age or older.
- Patients had a smoking history of more than 10 pack-years. A pack-year is defined as the equivalent of smoking one pack of cigarettes per day for a year.
- Patients performed pulmonary function tests as required in the protocol.
- Patients were able to inhale medication from the Handihaler device and had a good technique of inhaling aerosol administered from an MDI.
- All patients signed an Informed Consent Form prior to participation in the trial i.e., prior to pre-study washout of their usual pulmonary medications.
Who cannot join
- Patients with significant diseases other than COPD were excluded. A significant disease was defined as a disease which in the opinion of the investigator could either put the patient at risk because of participation in the study or a disease which could influence the results of the study or the patient's ability to participate in the study.
- Patients with clinically significant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defined a disease listed as an exclusion criterion, were excluded.
- All patients with a serum glutamate oxalacetate transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) twice the normal range, bilirubin 150% or creatinine 125% of the normal range were excluded regardless of the clinical condition. Repeated laboratory evaluations were not conducted in these subjects.
- Patients with a recent history (i.e. one year or less) of myocardial infarction were excluded.
- Patients with a recent history (i.e. three years or less) of heart failure or patients with any cardiac arrhythmia requiring drug therapy were excluded.
- Patients on regular use of daytime oxygen therapy were excluded.
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- Patients with known active tuberculosis were excluded.
- Patients with a history of cancer within the last five years were excluded. 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 were excluded.
- Patients who have undergone pulmonary resection or a thoracotomy for any reason were excluded.
- Patients with an upper respiratory tract infection in the past 6 weeks prior to the screening visit (=visit 1) or during the baseline period of 2 weeks (run-in period) were excluded.
- Patients with known hypersensitivity to anticholinergic drugs, lactose or any other component of the inhalation capsule delivery system or the MDI were excluded.
- Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction were excluded.
- Patients with known narrow-angle glaucoma were excluded.
- Patients who were being treated with cromolyn sodium or nedocromil sodium were excluded.
- Patients who were being treated with antihistamines were excluded.
- Patients who were using oral corticosteroid medication at unstable (i.e. less than 6 weeks on a stable dose) or at a dose in excess of the equivalent 10 mg of prednisone per day or 20 mg every other day were excluded
- Pregnant or nursing women or women of childbearing potential who were not using a medically approved means of contraception (e.g. oral contraceptives, intrauterine devices, or diaphragm) were excluded.
- Patients with a history of asthma, allergic rhinitis or atopy or who had a blood total eosinophil count more or equal to 400 per μl (males) or more or equal to 320 per μl (females) were excluded. Repeated eosinophil counts were not conducted in these patients.
- Patients with a history and/or active alcohol or drug abuse were excluded.
- Patients who had taken an investigational drug one month or six half-lives (whichever is greater) prior to the screening visit (=visit 1) were excluded.
About this study
Official title: A Comparison of 18 µg of Tiotropium Inhalation Capsules and Atrovent® Metered Dose Inhaler (2 Puffs of 20 µg, 4 Times Daily) in a Double-Blind, Double-Dummy, Efficacy and Safety Study in Adults With Chronic Obstructive Pulmonary Disease (COPD)
To compare the bronchodilator efficacy and safety of tiotropium inhalation capsules (18 µg once daily) and Atrovent® MDI (2 puffs of 20µg q.i.d.) among Filipino patients with COPD
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Tiotropium inhalation powder capsule, Placebo Metered Dose Inhaler, Ipratropium Bromide Metered Dose Inhaler, Placebo inhalation powder capsule
- 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 capsuleDrug
Placebo Metered Dose InhalerDrug
Ipratropium Bromide Metered Dose InhalerDrug
Also called Atrovent®
Placebo inhalation powder capsuleDrug
| Study group | Role | What they receive |
|---|---|---|
| Tiotropium & Placebo | Experimental | Not described Receives: Drug: Tiotropium inhalation powder capsule; Drug: Placebo Metered Dose Inhaler |
| Atrovent & Placebo | Active comparator | Not described Receives: Drug: Ipratropium Bromide Metered Dose Inhaler; Drug: Placebo inhalation powder capsule |
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) - Trough FEV1 response -
Measured: Baseline and week 4
Secondary outcomes (10)
Through FEV1 response
Measured: week 2
FEV1 for the first 3 hours post drug administration on each pulmonary function test day
Measured: Day 1, 15 and 29
Trough Forced Vital Capacity (FVC) response
Measured: week 2 and 4
Individual FEV1 measurements
Measured: Day 1, 15 and 29
Individual FVC measurements
Measured: Day 1, 15 and 29
FVC for the first 3 hours post drug administration on each pulmonary function
Measured: Day 1, 15 and 29
Amount of salbutamol (MDI) use (rescue medication)
Measured: 4 weeks
Patient evaluation questionnaire (PEQ)
Measured: 4 weeks
PEFR (peak expiratory flow rate) measured by the patient
Measured: 4 weeks
Number of patients with adverse events
Measured: 4 weeks
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 2001
- Primary completionApr 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
- 215 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
- NCT02172469
- Sponsor's protocol ID
- 205.243
- 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 Comparison of 18 µg of Tiotropium Inhalation Capsules and Atrovent® Metered Dose Inhaler (2 Puffs of 20 µg, 4 Times Daily) in a Double-Blind, Double-Dummy, Efficacy and Safety Study in Adults With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT02172469
- Acronym / sponsor ID
- 205.243
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2001
- Primary completion
- Apr 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.
To compare the bronchodilator efficacy and safety of tiotropium inhalation capsules (18 µg once daily) and Atrovent® MDI (2 puffs of 20µg q.i.d.) among Filipino patients with COPD
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tiotropium & Placebo | Experimental | Drug: Tiotropium inhalation powder capsule, Drug: Placebo Metered Dose Inhaler |
| Atrovent & Placebo | Active comparator | Drug: Ipratropium Bromide Metered Dose Inhaler, Drug: Placebo inhalation powder capsule |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- All patients had a diagnosis of chronic obstructive pulmonary disease according to the following criteria:
- Male or female patients 40 years of age or older.
- Patients had a smoking history of more than 10 pack-years. A pack-year is defined as the equivalent of smoking one pack of cigarettes per day for a year.
- Patients performed pulmonary function tests as required in the protocol.
- Patients were able to inhale medication from the Handihaler device and had a good technique of inhaling aerosol administered from an MDI.
Key exclusion criteria (21 listed)
- Patients with significant diseases other than COPD were excluded. A significant disease was defined as a disease which in the opinion of the investigator could either put the patient at risk because of participation in the study or a disease which could influence the results of the study or the patient's ability to participate in the study.
- Patients with clinically significant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defined a disease listed as an exclusion criterion, were excluded.
- All patients with a serum glutamate oxalacetate transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) twice the normal range, bilirubin 150% or creatinine 125% of the normal range were excluded regardless of the clinical condition. Repeated laboratory evaluations were not conducted in these subjects.
- Patients with a recent history (i.e. one year or less) of myocardial infarction were excluded.
- Patients with a recent history (i.e. three years or less) of heart failure or patients with any cardiac arrhythmia requiring drug therapy were excluded.
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 capsule | Drug | Tiotropium & Placebo |
| Placebo Metered Dose Inhaler | Drug | Tiotropium & Placebo |
| Ipratropium Bromide Metered Dose InhalerAlso: Atrovent® | Drug | Atrovent & Placebo |
| Placebo inhalation powder capsule | Drug | Atrovent & Placebo |
Primary outcome
Change from baseline in trough Forced Expiratory Volume in one second (FEV1) - Trough FEV1 response -
Time frame: Baseline and week 4
10 secondary outcomes
Through FEV1 response
Time frame: week 2
FEV1 for the first 3 hours post drug administration on each pulmonary function test day
Time frame: Day 1, 15 and 29
Trough Forced Vital Capacity (FVC) response
Time frame: week 2 and 4
Individual FEV1 measurements
Time frame: Day 1, 15 and 29
Individual FVC measurements
Time frame: Day 1, 15 and 29
FVC for the first 3 hours post drug administration on each pulmonary function
Time frame: Day 1, 15 and 29
Amount of salbutamol (MDI) use (rescue medication)
Time frame: 4 weeks
Patient evaluation questionnaire (PEQ)
Time frame: 4 weeks
PEFR (peak expiratory flow rate) measured by the patient
Time frame: 4 weeks
Number of patients with adverse events
Time frame: 4 weeks
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.
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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 capsule and Ipratropium Bromide Metered Dose Inhaler 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 8 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. 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) - Trough FEV1 response - (time frame: Baseline and week 4). 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.