Pulmonary Disease, Chronic ObstructivePhase 3NCT02172443
Comparison of Tiotropium Inhalation Capsules and Atrovent Metered Dose Inhaler (MDI) in a Efficacy and Safety Study in Adults With Chronic Obstructive Pulmonary Disease
A Phase 3 study testing tiotropium inhalation powder capsules and Atrovent in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
Trial summary
The objective of this study is to compare the bronchodilator efficacy and safety of tiotropium inhalation capsule (18 mcg once daily) and Atrovent MDI (2 puffs of 20 mcg q.i.d.) in patients with chronic obstructive pulmonary disease (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 Atrovent
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jun 2001to May 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
- COPD patients with an forced expiratory volume in one second (FEV1) <= 65% of predicted normal and FEV1 <= 70% of forced vital capacity (FVC)
- Male or female patients 40 years of age or older.
- Patient must have a smoking history of more than 10 pack-years. A pack-year is defined as the equivalent of smoking on pack of cigarettes per day for a year.
- Patient must be able to perform pulmonary function test as required in the protocol.
- Patient must be able to inhale medication from the handihaler device and should have a good technique of inhaling aerosol administered from MDI.
- All patients must sign an informed consent from prior to participation in the trail, prior to pre-study washout of their usual pulmonary medication.
Who cannot join
- Patient with significant disease other than COPD will be excluded. A significant disease is 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 result of the study or the patient's ability to participate in the study.
- Patients with clinically significant abnormal baseline hematology, 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) and serum glutamic-pyruvic transaminase (SGPT) twice the upper normal limit, bilirubin 150% or creatinine 125% of the upper normal limit will be excluded regardless of the clinical condition. Repeat laboratory evaluation will be not be conducted in these subjects.
- Patients with a recent history ( i.e. one year or less) of myocardial infarction.
- Patients with a recent history ( i.e. one year or less) of heart failure or patients with any cardiac arrhythmia requiring drug therapy.
- Patients with regular use of daytime oxygen therapy.
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- Patients with known active tuberculosis.
- Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma are allowed.
- Patients with a history of life-threatening pulmonary, or history of cystic fibrosis or bronchiectasis.
- Patients who have undergone pulmonary resection or a thoracotomy for any reason.
- Patients with an upper respiratory tract infection in the past 2 weeks prior to the screening visit (= Visit 1) or during the baseline period of 2-weeks (run-in period).
- Patients with known hypersensitivity to anticholinergic drugs, lactose or any other component of the inhalation capsule delivery system.
- Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction.
- Patients with known narrow-angle glaucoma.
- Patients who are being treated with cromolyn sodium or nedocromil sodium.
- Patients who are being treated with antihistamines.
- Patients using oral corticosteroid medication at unstable dosage (i.e. less than 6 weeks on a stable dose) or at a dose excess of the equivalent 10 mg of prednisone per day or 20 mg every day.
- Pregnant or nursing women or women of childbearing potential not using medically approved means of contraception (e.g. oral contraceptives, intrauterine devices, or diaphragm).
- Patients with a history of asthma, allergic rhinitis or atopy or who have a blood total eosinophil count >= 400 per microliter (males) or >= 320 per microliter (females). A repeat eosinophil count will not be conducted in these patients.
- Patients with a history and/or active alcohol or drug abuse.
- Patients who have taken an investigational drug on month or six half-lives (whichever is greater) prior to the screening visit (= Visit 1).
About this study
Official title: Comparison of 18 mcg of Tiotropium Inhalation Capsules and Atrovent Metered Dose Inhaler (2 Puffs of 20 mcg) in a Double Blind, Double Dummy, Efficacy and Safety Study in Adults With Chronic Obstructive Pulmonary Disease (COPD)
The objective of this study is to compare the bronchodilator efficacy and safety of tiotropium inhalation capsule (18 mcg once daily) and Atrovent MDI (2 puffs of 20 mcg q.i.d.) in patients with chronic obstructive pulmonary disease (COPD)
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- tiotropium inhalation powder capsules, Atrovent, placebo to Atrovent, placebo to tiotropium inhalation 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
AtroventDrug
placebo to AtroventDrug
placebo to tiotropium inhalation capsulesDrug
| Study group | Role | What they receive |
|---|---|---|
| tiotropium inhalation capsules | Experimental | Not described Receives: Drug: tiotropium inhalation powder capsules; Drug: placebo to tiotropium inhalation capsules |
| Atrovent MDI | Active comparator | Not described Receives: Drug: Atrovent; Drug: placebo to Atrovent |
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)
Measured: baseline, day 29
Secondary outcomes (9)
Change from baseline in forced expiratory volume in one second (FEV1), area under curve from 0 to 3 hours post drug administration
Measured: baseline, day 29
Change from baseline in forced vital capacity (FVC), area under curve from 0 to 3 hours post drug administration
Measured: baseline, day 29
Change from baseline in total score of patient evaluation questionnaire
Measured: baseline, day 29
Number of rescue medications
Measured: Up to day 29
Trough forced vital capacity (FVC) response
Measured: baseline, day 29
Number of patients with adverse events
Measured: up to day 29
Changes in vital signs (blood pressure, pulse rate)
Measured: up to day 29
Changes in electrocardiogram
Measured: up to day 29
Changes in safety laboratory tests
Measured: up to day 29
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 startJun 2001
- Primary completionMay 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
- 50 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
- NCT02172443
- Sponsor's protocol ID
- 205.232
- 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
- Comparison of 18 mcg of Tiotropium Inhalation Capsules and Atrovent Metered Dose Inhaler (2 Puffs of 20 mcg) in a Double Blind, Double Dummy, Efficacy and Safety Study in Adults With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT02172443
- Acronym / sponsor ID
- 205.232
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2001
- Primary completion
- May 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.
The objective of this study is to compare the bronchodilator efficacy and safety of tiotropium inhalation capsule (18 mcg once daily) and Atrovent MDI (2 puffs of 20 mcg q.i.d.) in patients with chronic obstructive pulmonary disease (COPD)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tiotropium inhalation capsules | Experimental | Drug: tiotropium inhalation powder capsules, Drug: placebo to tiotropium inhalation capsules |
| Atrovent MDI | Active comparator | Drug: Atrovent, Drug: placebo to Atrovent |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- COPD patients with an forced expiratory volume in one second (FEV1) <= 65% of predicted normal and FEV1 <= 70% of forced vital capacity (FVC)
- Male or female patients 40 years of age or older.
- Patient must have a smoking history of more than 10 pack-years. A pack-year is defined as the equivalent of smoking on pack of cigarettes per day for a year.
- Patient must be able to perform pulmonary function test as required in the protocol.
- Patient must be able to inhale medication from the handihaler device and should have a good technique of inhaling aerosol administered from MDI.
Key exclusion criteria (21 listed)
- Patient with significant disease other than COPD will be excluded. A significant disease is 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 result of the study or the patient's ability to participate in the study.
- Patients with clinically significant abnormal baseline hematology, 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) and serum glutamic-pyruvic transaminase (SGPT) twice the upper normal limit, bilirubin 150% or creatinine 125% of the upper normal limit will be excluded regardless of the clinical condition. Repeat laboratory evaluation will be not be conducted in these subjects.
- Patients with a recent history ( i.e. one year or less) of myocardial infarction.
- Patients with a recent history ( i.e. one year or less) of heart failure or patients with any cardiac arrhythmia requiring drug therapy.
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 inhalation capsules |
| Atrovent | Drug | Atrovent MDI |
| placebo to Atrovent | Drug | Atrovent MDI |
| placebo to tiotropium inhalation capsules | Drug | tiotropium inhalation capsules |
Primary outcome
Change from baseline in trough forced expiratory volume in one second (FEV1)
Time frame: baseline, day 29
9 secondary outcomes
Change from baseline in forced expiratory volume in one second (FEV1), area under curve from 0 to 3 hours post drug administration
Time frame: baseline, day 29
Change from baseline in forced vital capacity (FVC), area under curve from 0 to 3 hours post drug administration
Time frame: baseline, day 29
Change from baseline in total score of patient evaluation questionnaire
Time frame: baseline, day 29
Number of rescue medications
Time frame: Up to day 29
Trough forced vital capacity (FVC) response
Time frame: baseline, day 29
Number of patients with adverse events
Time frame: up to day 29
Changes in vital signs (blood pressure, pulse rate)
Time frame: up to day 29
Changes in electrocardiogram
Time frame: up to day 29
Changes in safety laboratory tests
Time frame: up to day 29
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 inhalation powder capsules and Atrovent 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 6 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 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?
Change from baseline in trough forced expiratory volume in one second (FEV1) (time frame: baseline, day 29). 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.