Chronic Obstructive Pulmonary DiseasePhase 2NCT02203474
A Study of 3 Doses of Tiotropium Hydrofluoralkane (HFA) Breath Actuated Inhaler (BAI), in Patients With Chronic Obstructive Pulmonary Disease
A Phase 2 study testing Tiotropium HFA BAI 5 mcg and Tiotropium 18 mcg Capsule in people with Chronic Obstructive Pulmonary Disease and COPD, run by Teva Branded Pharmaceutical Products R&D, Inc..
Trial summary
The primary objective of this study is to demonstrate the superiority of tiotropium hydrofluoroalkane (HFA) breath actuated inhaler (BAI) to placebo HFA BAI following repeated, once-daily dosing. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, COPD
- What is being tested?
- Tiotropium HFA BAI 5 mcg and Tiotropium 18 mcg Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Aug 2014
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients 40 to 80 years of age, as of the screening visit (SV), who have signed an informed consent prior to initiation of any study related procedures.
- Diagnosis of COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines.
- A measured post-bronchodilator (albuterol 360 mcg) forced expiratory volume in 1 second (FEV1) ≥30% and <80% of predicted normal at the SV. Predicted normal will be determined using National Health and Nutrition Examination Survey (NHANES) III standard values for Caucasians, African Americans and Mexican-Americans with adjustments to predicted values made for Asian American patients.
- A measured post-bronchodilator (albuterol 360 mcg) FEV1/forced vital capacity (FVC) <0.70 at the SV.
- A minimum body weight of 40 kg. (Note: For patients participating in the pharmacokinetic [PK] sub study a minimum body weight of 50 kg is required.)
- If female, is currently not pregnant, breast feeding, or attempting to become pregnant (for 4 weeks before the SV and throughout the duration of the study), and is of non-childbearing potential, defined as:
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- ≥1 year post-menopausal (6 months of spontaneous amenorrhea is permitted, provided there is a local record of serum follicle stimulating hormone >40 mIU/mL and this is source documented) or
- Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, salpingectomy, or hysterectomy)
- Or is of childbearing potential, has a negative serum pregnancy test, and is willing to commit to using a consistent and acceptable method of birth control, as defined below, for the duration of the study:
- Systemic contraception used for ≥1 month prior to screening, including birth control pills, transdermal patch, vaginal ring, implants, or injectables or
- Double barrier methods (spermicide with any of the following: condoms, cervical cap, diaphragm, and vaginal contraceptive film) or
- Intrauterine device (IUD) with a low failure rate defined as <1% per year (use of copper IUDs is not acceptable) Or is of childbearing potential and is not sexually active, has a negative serum pregnancy test, and, in the event the patient becomes sexually active, is willing to commit to using a consistent and acceptable method of birth control, as defined above, for the duration of the study. At the discretion of the investigator, total abstinence is acceptable in cases where the age, career (eg, priest), lifestyle, and/or sexual orientation of the patient ensures compliance.
- Current or ex-smoker with ≥10 pack-year smoking history (number of cigarette packs smoked per day multiplied by the number of years smoked; eg, 2 packs/day for 3 years equals a 6 pack-year history).
- Patient is free of any other medical conditions or concomitant treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the study.
- Able to perform technically acceptable and reproducible spirometry per American Thoracic Society/European Respiratory Society (ATS/ERS) 2005 guidelines and study guidelines, as defined in the protocol and study reference manual; this includes able to tolerate withdrawal of applicable medications during required spirometry assessments.
- Able to perform acceptable peak expiratory flow measurements.
- Able to maintain records (patient daily diary) during the study period as required by the protocol.
- Able to demonstrate the proper inhalation techniques required for correct use of all delivery devices (BAI and dry powder inhaler [DPI]) required in the study.
- Capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent and being compliant with all study requirements.
Who cannot join
- Chronic Obstructive Pulmonary Disease
- Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days following the patient's last study related visit (for eligible patients only, if applicable).
- Current evidence of a clinically significant or uncontrolled disease including, but not limited to: cardiovascular (eg, uncontrolled hypertension, congestive heart failure, known aortic aneurysm, clinically significant cardiac arrhythmia or coronary heart disease), hepatic, renal, hematological, neuropsychological, endocrine (eg, uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison's disease, Cushing's syndrome), gastrointestinal (eg, poorly controlled peptic ulcer, gastroesophageal reflux disease), or pulmonary (other than COPD such as asthma, sarcoidosis, non cystic fibrosis bronchiectasis, cystic fibrosis, bronchopulmonary dysplasia or a diagnosis of alpha 1 antitrypsin deficiency). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the patient at risk through participation, or which could affect the endpoint analysis if the disease/condition worsened during the study.
- History of and/or current diagnosis of asthma.
- History of a life-threatening COPD exacerbation - defined for this protocol as a COPD episode that required intubation or was associated with respiratory arrest.
- Thoracotomy with pulmonary resection.
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- Current congestive heart failure, history or current evidence of myocardial infarction (within 1 year of the SV), or current history of active ischemic heart disease (exertional or intermittent angina).
- History or current evidence of clinically significant cardiac arrhythmia or abnormality, including a diagnosis on screening ECG. Findings that are always considered clinically significant and will exclude the patient from study participation include, but are not limited to, the following:
- ventricular rate <45 beats per minute (bpm) or >100 bpm
- PR interval >240 msec
- evidence of 2nd- or 3rd-degree atrioventricular block (excluding MobitzI)
- evidence of supraventricular or ventricular ectopy or arrhythmias
- corrected QT interval (QTc) (Bazett's or Fridericia's method) >500 msec
- nonspecific intraventricular conduction delay >120 msec
- ST-T wave abnormalities (excluding nonspecific ST-T wave abnormalities) indicative of acute ischemia/infarction
- right or left complete bundle branch block
- artificial pacemaker
- The patient has a medical condition that may potentially be aggravated by an anticholinergic drug such as tiotropium, eg:
- The patient has a history or presence of glaucoma (particularly angle-closure glaucoma)
- The patient has symptomatic prostatic hyperplasia.
- The patient has a known history or any current evidence of renal impairment or urinary retention (eg, bladder outlet obstruction). This includes abnormal renal function test results at screening.
- History of malignancy (excluding treated non-melanoma skin cancers) within the past 5 years, regardless of the clinical significance or current stability of the disease.
- History of silent (or active) infections, including positive tests for human immunodeficiency virus (HIV) 1, HIV2, hepatitis B, hepatitis C, or tuberculosis.
- Occurrence of any upper or lower respiratory infection, including but not limited to the common cold and flu, sinusitis, tonsillitis, pneumonia, bronchitis, or an ear infection (including otitis media and externa) which is not resolved by 4 weeks or more prior to the SV/informed consent.
- Occurrence of a COPD exacerbation which is not resolved by 4 weeks or more prior to the SV/informed consent.
- Note: An exacerbation of COPD is defined as any worsening of the patient's baseline COPD symptoms requiring any treatment beyond study medication, rescue albuterol or the patient's regular maintenance treatment. This includes requiring the use of systemic corticosteroids, antibiotics and/or emergency room visit or hospitalization.
- Patients who require regular use of daytime oxygen therapy.
- Patients who have started or stopped an exercise rehabilitation program within 4 weeks of the SV.
- Known or suspected hypersensitivity or idiosyncratic reaction to tiotropium, or to any ingredients used in the study medication formulations.
- Severe allergy to milk protein.
- Significant adverse drug reactions, including allergy or hypersensitivity reactions, to atropine or any anticholinergic substance related pharmacologically to atropine (eg, ipratropium or oxitropium).
- Use of any prohibited concomitant medications within the required (per protocol) washout periods prior to the SV.
- Treatment with orally administered (excluding orally inhaled) β-adrenergic agonists (ie, oral albuterol).
- Recent initiation of treatment or dose titration with β-adrenergic receptor antagonists (eg, non-selective β-receptor blocking agents such as β-blocking anti-hypertensive products) administered by any route. Permitted exceptions are: (1) Patients treated on a stable dose of non-selective β-receptor blocking agents for 3 months prior to SV or longer may be considered for enrollment if expected to maintain the same dose throughout the study and (2) Patients on a stable dose of cardioselective β1 adrenergic receptor antagonists (eg, atenolol, metaprolol, bisoprolol) for at least 1 week prior to the SV are permitted if expected to maintain the same dose throughout the study.
- Treatment with drugs commonly recognized to prolong the QTc interval (eg, quinolones, amiodarone, disopyramide, quinidine, sotalol, chlorpromazine, haloperidol, ketoconazole, terfenadine, cisapride, and terodiline).
- Treatment with strong cytochrome P450 (CYP) 2D6 or CYP3A4 inducers or inhibitors (eg, quinidine, ketoconazole and gestodene) within 30 days prior to the SV.
- For patients using an inhaled corticosteroid, initiation or change in the dose of inhaled corticosteroids within the last 30 days prior to the SV, and/or the patient is not expected to maintain a stable dose of inhaled corticosteroids during the course of the study.
- For patients using maintenance oral corticosteroids for COPD, the average daily dose should not be greater than10 mg of prednisone equivalent per day and the dose should have been stable over the 6 weeks prior to the SV. The patient's prior oral corticosteroid (OCS) dose should be maintained without change during the study. (Note that oral steroid bursts completed 6 weeks or more prior to screening are acceptable.)
- Exposure to any investigational drug within 30 days or 6 half-lives (whichever is longer) prior to the SV.
- Has a history of alcohol and/or substance abuse within the past 5 years. aa. Vulnerable patients (eg, persons kept in detention). bb. The patient is an employee of the study site or has an immediate family member or household member involved with the conduct of the study (including participation in the study).
About this study
Official title: A Randomized, Double-Blind, Double-Dummy, Parallel Group, Dose-Ranging Study of 3 Doses of Tiotropium Hydrofluoralkane (HFA) Breath Actuated Inhaler (BAI), Placebo HFA BAI, and Open-Label SPIRIVA® HandiHaler® (18 mcg) in Patients With Chronic Obstructive Pulmonary Disease
The primary objective of this study is to demonstrate the superiority of tiotropium hydrofluoroalkane (HFA) breath actuated inhaler (BAI) to placebo HFA BAI following repeated, once-daily dosing.
- Conditions
- Chronic Obstructive Pulmonary Disease, COPD
- Being tested
- Tiotropium HFA BAI 5 mcg, Tiotropium 18 mcg Capsule, 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.
Tiotropium HFA BAI 5 mcgDrug
Tiotropium 18 mcg CapsuleDrug
Also called SPIRIVA HandiHaler
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Tiotropium HFA BAI 5 mcg | Experimental | 1 inhalation from each of 3 inhalers containing either Tiotropium HFA BAI 5 mcg or placebo daily Receives: Drug: Tiotropium HFA BAI 5 mcg |
| Tiotropium HFA BAI 10 mcg | Experimental | 1 inhalation from each of 3 inhalers containing either Tiotropium HFA BAI 5 mcg or placebo daily Receives: Drug: Tiotropium HFA BAI 5 mcg |
| Tiotropium HFA BAI 15 mcg | Experimental | 1 inhalation from each of 3 inhalers containing either Tiotropium HFA BAI 5 mcg or placebo daily Receives: Drug: Tiotropium HFA BAI 5 mcg |
| SPIRIVA HandiHaler | Active comparator | 2 inhalations from one 18 mcg capsule daily Receives: Drug: Tiotropium 18 mcg Capsule |
| Placebo | Placebo comparator | 1 inhalation from each of 3 inhalers containing either Tiotropium HFA BAI 5 mcg or placebo daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1 AUC0-24
Measured: Day 28
Secondary outcomes (4)
FEV1 (AUC0-24)
Measured: Day 1
Trough FEV1
Measured: Day 2
Percentage of patients with a COPD exacerbation
Measured: 28 Days
Percentage of Patients with Adverse Events
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teva Medical Expert, MD, Study director, Teva Branded Pharmaceutical Products R&D, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02203474
- Sponsor's protocol ID
- TBB-COPD-20009
- Status last verified
- Nov 2021
- First submitted
- 28 Jul 2014
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Double-Dummy, Parallel Group, Dose-Ranging Study of 3 Doses of Tiotropium Hydrofluoralkane (HFA) Breath Actuated Inhaler (BAI), Placebo HFA BAI, and Open-Label SPIRIVA® HandiHaler® (18 mcg) in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02203474
- Acronym / sponsor ID
- TBB-COPD-20009
- Conditions
- Chronic Obstructive Pulmonary Disease, COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 30 Jul 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 demonstrate the superiority of tiotropium hydrofluoroalkane (HFA) breath actuated inhaler (BAI) to placebo HFA BAI following repeated, once-daily dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Tiotropium HFA BAI 5 mcg | Experimental | Drug: Tiotropium HFA BAI 5 mcg1 inhalation from each of 3 inhalers containing either Tiotropium HFA BAI 5 mcg or placebo daily |
| Tiotropium HFA BAI 10 mcg | Experimental | Drug: Tiotropium HFA BAI 5 mcg1 inhalation from each of 3 inhalers containing either Tiotropium HFA BAI 5 mcg or placebo daily |
| Tiotropium HFA BAI 15 mcg | Experimental | Drug: Tiotropium HFA BAI 5 mcg1 inhalation from each of 3 inhalers containing either Tiotropium HFA BAI 5 mcg or placebo daily |
| SPIRIVA HandiHaler | Active comparator | Drug: Tiotropium 18 mcg Capsule2 inhalations from one 18 mcg capsule daily |
| Placebo | Placebo comparator | Drug: Placebo1 inhalation from each of 3 inhalers containing either Tiotropium HFA BAI 5 mcg or placebo daily |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Male or female patients 40 to 80 years of age, as of the screening visit (SV), who have signed an informed consent prior to initiation of any study related procedures.
- Diagnosis of COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines.
- A measured post-bronchodilator (albuterol 360 mcg) forced expiratory volume in 1 second (FEV1) ≥30% and <80% of predicted normal at the SV. Predicted normal will be determined using National Health and Nutrition Examination Survey (NHANES) III standard values for Caucasians, African Americans and Mexican-Americans with adjustments to predicted values made for Asian American patients.
- A measured post-bronchodilator (albuterol 360 mcg) FEV1/forced vital capacity (FVC) <0.70 at the SV.
- A minimum body weight of 40 kg. (Note: For patients participating in the pharmacokinetic [PK] sub study a minimum body weight of 50 kg is required.)
Key exclusion criteria (40 listed)
- Chronic Obstructive Pulmonary Disease
- Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days following the patient's last study related visit (for eligible patients only, if applicable).
- Current evidence of a clinically significant or uncontrolled disease including, but not limited to: cardiovascular (eg, uncontrolled hypertension, congestive heart failure, known aortic aneurysm, clinically significant cardiac arrhythmia or coronary heart disease), hepatic, renal, hematological, neuropsychological, endocrine (eg, uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison's disease, Cushing's syndrome), gastrointestinal (eg, poorly controlled peptic ulcer, gastroesophageal reflux disease), or pulmonary (other than COPD such as asthma, sarcoidosis, non cystic fibrosis bronchiectasis, cystic fibrosis, bronchopulmonary dysplasia or a diagnosis of alpha 1 antitrypsin deficiency). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the patient at risk through participation, or which could affect the endpoint analysis if the disease/condition worsened during the study.
- History of and/or current diagnosis of asthma.
- History of a life-threatening COPD exacerbation - defined for this protocol as a COPD episode that required intubation or was associated with respiratory arrest.
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 HFA BAI 5 mcg | Drug | Tiotropium HFA BAI 10 mcg, Tiotropium HFA BAI 15 mcg, Tiotropium HFA BAI 5 mcg |
| Tiotropium 18 mcg CapsuleAlso: SPIRIVA HandiHaler | Drug | SPIRIVA HandiHaler |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
FEV1 AUC0-24
Time frame: Day 28
4 secondary outcomes
FEV1 (AUC0-24)
Time frame: Day 1
Trough FEV1
Time frame: Day 2
Percentage of patients with a COPD exacerbation
Time frame: 28 Days
Percentage of Patients with Adverse Events
Time frame: 28 Days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
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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.
Teva Medical Expert, MD study director
Teva Branded Pharmaceutical Products R&D, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tiotropium HFA BAI 5 mcg and Tiotropium 18 mcg Capsule in people with Chronic Obstructive Pulmonary Disease and COPD, run by Teva Branded Pharmaceutical Products R&D, Inc..
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 19 inclusion and 40 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: withdrawn, as of the sponsor's last update on 9 Nov 2021. 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 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 was withdrawn before enrolling participants, so there are no results.
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?
FEV1 AUC0-24 (time frame: Day 28). 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 9 Nov 2021.