Comparing the pharmacokinetics (the way the body absorbs, distributes, and gets rid of a drug), effectiveness and safety of Tiotropium Bromide in three different types of inhalers (Breath Actuated Inhaler, SPIRIVA® HandiHaler®, Respimat® Soft Mist™ Inhaler) in subjects with Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 15.0Level: PTClassification code 10009033Term: Chronic obstructive pulmonary diseaseSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2012-003413-33-DE
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Written informed consent signed and dated by the subject before conducting any study related procedure
2. Male or female subjects 40 -80 years of age, as of the Screening Visit
3. Diagnosis of COPD as defined by the GOLD (Global Initiative for Chronic Obstructive Lung Disease) Guidelines
4. A pre-bronchodilator Peak Inspiratory Flow (PIF) rate= 30 L/ min as measured with the In-CheckTM DIAL training device.
5. A measured post-bronchodilator (ipratropium bromide) FEV1 >30% and <80% of predicted normal for height, age and gender at the Screening Visit (SV). NHANES III predicted values will be used and adjustments to predicted values will be made for African-American subjects [1].
6. A measured post-bronchodilator (ipratropium bromide) FEV1/FVC <0.70 at the Screening Visit (SV)
7. If female, is currently not pregnant, breast feeding, or attempting to become pregnant (for 4 weeks before the Screening Visit (SV) and throughout the duration of the study), and is of
• Non-childbearing potential, defined as:
o =1 year post-menopausal or
o Surgically sterile (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:
o Systemic contraception used for =1 month prior to screening, including birth control pills, transdermal patch, vaginal ring, implants, or injectables or
o Double barrier methods (condoms, cervical cap, diaphragm, and vaginal contraceptive film with spermicide) or
o Intrauterine device (IUD) with a low failure rate defined as <1% per year (use of copper IUDs are excluded)
or is of
• Childbearing potential and not sexually active, has a negative serum pregnancy test, and is willing to commit to using a consistent and acceptable method of birth control as defined above for the duration of the study, in the event the subject becomes sexually active
8. Current or ex-smoker with =10 pack-year smoking history
9. Subject is free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the subject at increased risk during the study
10. Able to perform technically acceptable and reproducible spirometry per study guidelines as defined in the protocol and study procedures manual.
11. Able to demonstrate the proper inhalation techniques required for correct use of all delivery devices required in the study
12. 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16
1 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 subject’s last study related visit
2 History or current evidence of a clinically significant or uncontrolled disease including, but not limited to: cardiovascular, hepatic, renal, haematological, neuropsychological, endocrine, gastrointestinal or pulmonary (other than COPD such as asthma, sarcoidosis, non-CF 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 subject at risk through participation, or which could affect the endpoint analysis if the disease/condition exacerbated during the study
3 History of and/or current diagnosis of asthma
4 History of a life-threatening COPD exacerbation
5Thoracotomy with pulmonary resection
6 Current congestive heart failure, history or current evidence of myocardial infarction (within 3 yrs of the Screening Visit [SV]), or history or current evidence of ischemic heart disease, including a diagnosis on screening ECG
7 History or current evidence of clinically significant cardiac arrhythmia, including a diagnosis on screening ECG
8 Presence of angle-closure glaucoma
9 History of malignancy (excluding basal cell carcinoma) within the past 5 years, regardless of the clinical significance or current stability of the disease
10 Known history or any current evidence of renal impairment or urinary retention. This includes abnormal renal function test results at screening
11 Presence of symptomatic prostatic hyperplasia
12 History of silent infections, including positive tests for HIV1, HIV2, Hepatitis B, Hepatitis C, or tuberculosis
13 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 14 days prior to randomization
14 Occurrence of a COPD exacerbation which is not resolved by 14 days prior to randomization
15 Subjects who require oxygen therapy and in the investigator’s opinion, will be unable to abstain from the use of oxygen therapy during testing
16 Subjects who have started or stopped an exercise rehabilitation program within 4 weeks of SV
17 Known or suspected hypersensitivity or idiosyncratic reaction to tiotropium, or to any ingredients used in the study medication formulations
18 Severe allergy to milk protein
19 Significant adverse drug reactions, including allergy or hypersensitivity reactions, to atropine or any anticholinergic substance related pharmacologically to atropine
20 Use of any prohibited concomitant medications within the prescribed (per protocol) withdrawal periods prior to SV
21 Treatment with orally administered (excluding orally inhaled) ß-adrenergics
22 Treatment with ß–adrenergic receptor antagonists administered by any route. The single exception is that cardioselective ß1–adrenergic receptor antagonists are permitted provided that subjects have been on a stable dose for at least 1 week prior to SV and subjects are expected to be able to maintain the same dose throughout the study
23 Treatment with drugs commonly recognized to prolong the QTc interval
24 Treatment with any known CYP2D6 or CYP3A4 inhibitors within 30 days prior to SV
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method