A Study of 3 Doses of Tiotropium Hydrofluoralkane (HFA) Breath Actuated Inhaler (BAI), in Patients With Chronic Obstructive Pulmonary Disease

NCT02203474 | Withdrawn Phase 2

• 1 other identifier: TBB-COPD-20009
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease; COPD

Outcome Measures

Primary Outcomes (1)

• FEV1 AUC0-24

  Day 28

Secondary Outcomes (4)

• FEV1 (AUC0-24)

  Day 1

• Trough FEV1

  Day 2

• Percentage of patients with a COPD exacerbation

  28 Days

• Percentage of Patients with Adverse Events

  28 Days

Study Arms (5)

Tiotropium HFA BAI 5 mcg

EXPERIMENTAL

1 inhalation from each of 3 inhalers containing either Tiotropium HFA BAI 5 mcg or placebo daily

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

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

Drug: Tiotropium HFA BAI 5 mcg

SPIRIVA HandiHaler

ACTIVE COMPARATOR

2 inhalations from one 18 mcg capsule daily

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

Drug: Placebo

Interventions

Tiotropium HFA BAI 5 mcg DRUG

Tiotropium HFA BAI 10 mcg; Tiotropium HFA BAI 15 mcg; Tiotropium HFA BAI 5 mcg

Tiotropium 18 mcg Capsule DRUG

Also known as: SPIRIVA HandiHaler

SPIRIVA HandiHaler

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• ≥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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2014
• First Posted: July 30, 2014
• Study Start: August 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: November 9, 2021

Record last verified: 2021-11