Pulmonary Disease, Chronic ObstructivePhase 2NCT02242240
Lung Function Changes Following the Addition of Formoterol to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study testing Formoterol twice daily, Formoterol once daily and Tiotropium once daily in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
Trial summary
Study to establish the lung function effects of added formoterol (12μg QD and BID) during 2-week periods to pharmacodynamic steady state of tiotropium(18μg QD) 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?
- Formoterol twice daily, Formoterol once daily and Tiotropium once daily
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- No sites listed yet
- Study dates
- Mar 2001to Dec 2001
- Phase
- Phase 2
- 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 must sign an informed consent consistent with international conference of harmonization (ICH)-good clinical practice (GCP) guidelines prior to participation in the trial, which includes medication washout and restrictions
- All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
- Patients must have relatively stable* moderate to severe airway obstruction with an FEV1 ≤ 60% of predicted normal and FEV1 ≤ 70% of FVC (Visit 1)
- 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. The enrollment of patients who have had an exacerbation within the six-week period prior to planned study entry should be postponed for at least six weeks
- Predicted normal values will be calculated according to european community for coal and steel (ECCS):
- Males: FEV1 predicted (L) = 4.30 x Height (metres) - 0.029 x Age (years) - 2.49
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- Females: FEV1 predicted (L) = 3.95 x Height (metres) - 0.025 x Age (years) - 2.60
- Male or female patients 40 years of age or older
- Patients must be current or ex-smokers with a smoking history of more than 10 pack-years
- patients who have never smoked cigarettes must be excluded
- Patients must be able to perform technically acceptable pulmonary function tests and must be able to maintain records (Patient Daily Record) during the study period as required in the protocol
- Patients must be able to inhale medication from inhalation capsule delivery systems (the HandiHaler® for the tiotropium and placebo capsules and the Aerolizer® for the formoterol capsule) and from a metered dose inhaler
Who cannot join
- Patients with significant diseases 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 results of the study or the patient's ability to participate in the study
- Patients with clinically relevant abnormal baseline hematology, blood chemistry, or urinalysis if the abnormality defines a disease listed as an exclusion criterion
- All patients with a serum glutamate oxaloacetate transaminase (SGOT) > 80 IU/L, serum glutamate pyruvate transaminase (SGPT) > 80 IU/L, bilirubin > 17 µmol/L or creatinine > 110 µmol/L (males) / 95 µmol/L (females) will be excluded regardless of clinical condition. Repeat laboratory evaluation will not be conducted in these patients
- Patients with a recent history (i.e., six months or less) of myocardial infarction
- Patients with any cardiac arrhythmia requiring drug therapy or who have been hospitalized for heart failure within the past three years
- Patients with known active tuberculosis
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- Patients on oxygen therapy
- Patients with 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 1
- Patients with any respiratory infection in the six weeks prior to the Screening Visit (Visit 1) or during the baseline period
- 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 are allowed. Patients with successfully treated cancers greater than five years prior to entry will be allowed
- Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction
- Patients with known narrow-angle glaucoma
- Patients using cromolyn sodium or nedocromil sodium
- Patients using treated with antihistamines (H1 receptor antagonists)
- Patients using treated with theophyllines
- Patients on ß-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, allergic rhinitis or atopy or who have a total blood eosinophil count ≥ 600 mm3. A repeat eosinophil count will not be conducted in these patients
- Patients with significant alcohol or drug abuse within the past two years
- Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit (Visit 1)
- Patients who are currently in a pulmonary rehabilitation program or who have completed a program in the six weeks prior to screening (Visit 1)
- Patients who currently participating in another study
About this study
Official title: Lung Function Changes Following the Addition of Formoterol Inhalation Capsules (12 µ Once or Twice Daily) to Pharmacodynamic Steady State of Once Daily Tiotropium (18 µg) Inhalation Capsule in Patients With COPD
Study to establish the lung function effects of added formoterol (12μg QD and BID) during 2-week periods to pharmacodynamic steady state of tiotropium(18μg QD)
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Formoterol twice daily, Formoterol once daily, Tiotropium once daily, Placebo
- 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.
Formoterol twice dailyDrug
Formoterol once dailyDrug
Tiotropium once dailyDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Tiotropium with single dose of formoterol | Experimental | Not described Receives: Drug: Formoterol once daily; Drug: Tiotropium once daily |
| Tiotropium with double dose of formoterol | Experimental | Not described Receives: Drug: Formoterol twice daily; Drug: Tiotropium once daily |
| Tiotropium with Placebo | Experimental | Not described Receives: Drug: Tiotropium once daily; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve from time point zero to 24 hours (AUC0-24h) for forced expiratory volume in one second (FEV1)
Measured: Pre-dose, up to 24 hours after start of treatment
Area under the curve from 12 to 24 hours (AUC12-24h) for forced expiratory volume in one second (FEV1)
Measured: 12 to 24 hours after start of treatment
Secondary outcomes (12)
Trough FEV1 response on each pulmonary function test day
Measured: 24 hours after intake of the last morning dose
Trough forced vital capacity (FVC) response on each pulmonary function test day
Measured: Up to 24 hours after start of treatment
FEV1 AUC0-12h on each pulmonary function test day
Measured: Up to 12 hours after start of treatment
Individual FEV1measurements at each time point
Measured: up to day 58 day after start of treatment
Individual FVC measurements at each time point
Measured: up to day 58 day after start of treatment
Individual inspiratory capacity (IC) measurements at each time point
Measured: up to day 58 day after start of treatment
Peak expiratory flow rate (PEFR) measured by the patients at home twice daily
Measured: up to day 79 after start of treatment
Amount of salbutamol therapy used during the treatment period
Measured: up to day 79 after start of treatment
Number of patients with adverse events
Measured: Up to 93 days
FVC AUC0-12h on each pulmonary function test day
Measured: up to day 58 day after start of treatment
Peak FEV1 response on each pulmonary function test day
Measured: within 3 hours after treatment
Peak FVC response on each pulmonary function test day
Measured: within 3 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startMar 2001
- Primary completionDec 2001
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 95 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
- NCT02242240
- Sponsor's protocol ID
- 1184.2
- Status last verified
- Sep 2014
- First submitted
- 16 Sep 2014
- Last updated
- 17 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Function Changes Following the Addition of Formoterol Inhalation Capsules (12 µ Once or Twice Daily) to Pharmacodynamic Steady State of Once Daily Tiotropium (18 µg) Inhalation Capsule in Patients With COPD
- ClinicalTrials.gov ID
- NCT02242240
- Acronym / sponsor ID
- 1184.2
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Mar 2001
- Primary completion
- Dec 2001 (actual)
- First posted
- 17 Sep 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.
Study to establish the lung function effects of added formoterol (12μg QD and BID) during 2-week periods to pharmacodynamic steady state of tiotropium(18μg QD)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tiotropium with single dose of formoterol | Experimental | Drug: Formoterol once daily, Drug: Tiotropium once daily |
| Tiotropium with double dose of formoterol | Experimental | Drug: Formoterol twice daily, Drug: Tiotropium once daily |
| Tiotropium with Placebo | Experimental | Drug: Tiotropium once daily, Drug: Placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- All patients must sign an informed consent consistent with international conference of harmonization (ICH)-good clinical practice (GCP) guidelines prior to participation in the trial, which includes medication washout and restrictions
- All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
- Male or female patients 40 years of age or older
- Patients must be current or ex-smokers with a smoking history of more than 10 pack-years
- Patients must be able to perform technically acceptable pulmonary function tests and must be able to maintain records (Patient Daily Record) during the study period as required in the protocol
Key exclusion criteria (25 listed)
- Patients with significant diseases 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 results of the study or the patient's ability to participate in the study
- Patients with clinically relevant abnormal baseline hematology, blood chemistry, or urinalysis if the abnormality defines a disease listed as an exclusion criterion
- All patients with a serum glutamate oxaloacetate transaminase (SGOT) > 80 IU/L, serum glutamate pyruvate transaminase (SGPT) > 80 IU/L, bilirubin > 17 µmol/L or creatinine > 110 µmol/L (males) / 95 µmol/L (females) will be excluded regardless of clinical condition. Repeat laboratory evaluation will not be conducted in these patients
- Patients with a recent history (i.e., six months or less) of myocardial infarction
- Patients with any cardiac arrhythmia requiring drug therapy or who have been hospitalized 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 |
|---|---|---|
| Formoterol twice daily | Drug | Tiotropium with double dose of formoterol |
| Formoterol once daily | Drug | Tiotropium with single dose of formoterol |
| Tiotropium once daily | Drug | Tiotropium with Placebo, Tiotropium with double dose of formoterol, Tiotropium with single dose of formoterol |
| Placebo | Drug | Tiotropium with Placebo |
Primary outcome
Area under the curve from time point zero to 24 hours (AUC0-24h) for forced expiratory volume in one second (FEV1)
Time frame: Pre-dose, up to 24 hours after start of treatment
Area under the curve from 12 to 24 hours (AUC12-24h) for forced expiratory volume in one second (FEV1)
Time frame: 12 to 24 hours after start of treatment
12 secondary outcomes
Trough FEV1 response on each pulmonary function test day
Time frame: 24 hours after intake of the last morning dose
Trough forced vital capacity (FVC) response on each pulmonary function test day
Time frame: Up to 24 hours after start of treatment
FEV1 AUC0-12h on each pulmonary function test day
Time frame: Up to 12 hours after start of treatment
Individual FEV1measurements at each time point
Time frame: up to day 58 day after start of treatment
Individual FVC measurements at each time point
Time frame: up to day 58 day after start of treatment
Individual inspiratory capacity (IC) measurements at each time point
Time frame: up to day 58 day after start of treatment
Peak expiratory flow rate (PEFR) measured by the patients at home twice daily
Time frame: up to day 79 after start of treatment
Amount of salbutamol therapy used during the treatment period
Time frame: up to day 79 after start of treatment
Number of patients with adverse events
Time frame: Up to 93 days
FVC AUC0-12h on each pulmonary function test day
Time frame: up to day 58 day after start of treatment
Peak FEV1 response on each pulmonary function test day
Time frame: within 3 hours after treatment
Peak FVC response on each pulmonary function test day
Time frame: within 3 hours after treatment
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 17 Sep 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 2 study testing Formoterol twice daily, Formoterol once daily and Tiotropium once daily 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 12 inclusion and 25 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 17 Sep 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Area under the curve from time point zero to 24 hours (AUC0-24h) for forced expiratory volume in one second (FEV1) (time frame: Pre-dose, up to 24 hours after start of treatment). 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 17 Sep 2014.