Investigate the Impact of Early Treatment Initiation With Tiotropium in Patients Recovering From Hospitalization for an Acute COPD Exacerbation 2

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01662986
First received: August 9, 2012
Last updated: September 3, 2014
Last verified: September 2014
  Purpose

A randomized, placebo-controlled, double-blind, parallel group, multi-center study to assess the safety and efficacy of tiotropium bromide (18 µg) delivered via the HandiHaler® in Chronic Obstructive Pulmonary Disease (COPD) subjects recovering from hospitalization for an acute exacerbation (Hospital Discharge Study 2)


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: tiotropium bromide
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-controlled, Double-blind, Parallel Group, Multi Center Study to Assess the Safety and Efficacy of Tiotropium Bromide (18 µg) Delivered Via the HandiHaler® in Chronic Obstructive Pulmonary Disease (COPD) Subjects Recovering From Hospitalization for an Acute Exacerbation (Hospital Discharge Study 2)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Primary endpoint is trough FEV1 (forced expiratory volume in 1 second) at 12 weeks on study medication. Trough FEV1 is defined as the FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after last inhalation of drug. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Primary endpoint for combined data from trials 205.477 and 205.478 will be time to the first adverse clinical outcome event defined as the combined endpoint of COPD exacerbations per BI definition, all-cause re-hospitalization, or all-cause mortality. [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of events:COPD exacerbation [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Time to event: Time to first COPD exacerbation [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Number of subjects with events: COPD exacerbation [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Time to event: Time to recovery (EXACT-PRO) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Number of subjects with events: 30-day readmission rates [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Number of subjects with events: All-cause hospitalization [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Lung function: Trough FVC at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Number of subjects with events: Adverse clinical outcome [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Number of events: All-cause hospitalization [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Time to event: Time to first all-cause hospitalization [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Time to event: Time to first adverse clinical outcome [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Lung function: Trough FEV1, FVC at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 79
Study Start Date: August 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 18 mcg tiotropium bromide
Patient to receive one tiotropium bromide inhalation powder capsule daily (in the morning) via HandiHaler
Drug: tiotropium bromide
18 mcg QD
Placebo Comparator: placebo
Patient to receive one placebo inhalation powder capsule daily (in the morning) via HandiHaler
Drug: Placebo
QD

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

The following inclusion criteria apply at Visit 0:

  1. All subjects must sign an informed consent consistent with the International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial and conducting any study procedures
  2. Male or female subjects 40 years of age or older.
  3. Hospitalization for a primary diagnosis of acute COPD exacerbation for =14 days. Determination of accuracy of admission diagnosis will be at the discretion of the investigator.
  4. Patient reported hospital length of stay and discharge date (confirmed with hospital discharge summary/hospital records; however, medical record confirmation may occur following randomization).

    The following inclusion criteria apply at Visit 1:

  5. Discharged from the hospital =10 days from date of randomization.
  6. All subjects must have a diagnosis of COPD (P12-01205), and have documented airway obstruction with a post-bronchodilator FEV1/FVC <0.7(See Section 5.1.2, Pulmonary Function Testing). The diagnosis of COPD can be made at Visit 1 if no PFT data available within the past 12 months.
  7. Subjects must be current or ex-smoker with a smoking history of =10 pack-years:

Pack-years = Number of cigarettes/day x years of smoking 20 cigarettes/ pack 8. Subjects must be able to inhale medication in a competent manner from the HandiHaler® device (Appendix 10.1) and from a metered dose inhaler (MDI).

Exclusion criteria:

The following exclusion criterion applies at Visit 0:

  1. No more than 30 days of therapy with any long-acting inhaled anticholinergic over preceding 3 months prior to discharge from the hospital, and no therapy with any long acting anticholinergic post discharge (no use between hospital discharge and randomization) or any other restricted concomitant medications

    The following exclusion criteria apply at Visit 1:

  2. Presence of a significant disease (in the opinion of the investigator) which may put the subject at risk because of participation in the study or may influence the subject's ability to participate in the study for up to 2 years.
  3. A documented history of myocardial infarction during the hospitalization preceding randomization. Subjects being stable with a history of cardiac stents are permitted.
  4. Any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year.
  5. Subjects with asthma (subject treated for asthma in the last 2 years, history of childhood asthma is permitted), cystic fibrosis, clinical diagnosis of bronchiectasis, interstitial lung disease, pulmonary thromboembolic disease or known active tuberculosis.

7. Malignancy for which the subject has undergone resection, radiation, chemotherapy or biological treatments within the last two years or is currently on active radiation therapy, chemotherapy or biological treatment. Subjects with treated basal cell carcinoma and non-invasive squamous cell skin carcinoma are allowed.

8. Hospitalization for cardiac failure (New York Heart Association (NYHA) class III or IV) during the hospitalization preceding randomization.

9. Known hypersensitivity to anticholinergic drugs, lactose, or any other components of the HandiHaler® or MDI inhalation solution delivery system.

10. Known moderate to severe renal impairment as judged by the investigator. 11. Known narrow angle glaucoma as judged by the investigator. 12. Significant symptomatic prostatic hyperplasia or bladder-neck obstruction. Subjects whose symptoms are controlled on treatment may be included.

13. Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices, diaphragm or sub dermal implants e.g., Norplant®) for at least three months prior to and for the duration of the trial.

14. Significant alcohol or drug abuse within the past 12 months. 15. Previously randomized in this study or currently participating in another interventional study.

16. Visual impairment that as judged by the investigator does not allow the subject to independently read and complete the questionnaires and eDiary.

17. Any significant or new ECG findings at Visit 1 as judged by the investigator, including, but not limited to signs of acute ischemia, arrhythmia.

18. Treatment with any restricted pulmonary medication. 19. Residing in an assisted living facility.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01662986

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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01662986     History of Changes
Other Study ID Numbers: 205.478
Study First Received: August 9, 2012
Last Updated: September 3, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Tiotropium
Bromides
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 01, 2014