Clinical trial NCT01662986: Investigate the Impact of Early Treatment Initiation With Tiotropium in Patients Recovering From Hospitalization for an Acute COPD Exacerbation 2
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2012-08-13
Enrollment: 79
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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)


Eligibility 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 Force Expiratory Volume in 1 second (FEV1)\\ Force vital capacity (FVC) \<0.7(See Section 5.1.2, Pulmonary Function Testing). The diagnosis of COPD can be made at Visit 1 if no Pulmonary Function Testing (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.

Primary outcomes:
measure: Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug.
timeFrame: Baseline and 12 weeks
measure: Percentage of Patients With Next Adverse Clinical Outcome Event From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987).
timeFrame: from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years
Secondary outcomes:
measure: Change From Baseline of Trough FVC at 12 Weeks on Study Drug.
timeFrame: baseline and 12 weeks
measure: Percentage of Patients With Adverse Clinical Event During on Study.
timeFrame: from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years
measure: Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)
timeFrame: Baseline and week 12
measure: Change From Baseline of Trough FVC at 12 Weeks From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)
timeFrame: Baseline and week 12
measure: Percentage of Patients With COPD Exacerbation From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)
timeFrame: from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years
measure: Percentage of Patients With All-cause Hospitalization From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987).
timeFrame: from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years
measure: Percentage of Patients With 30-day Hospital Readmission Rates Outcome Event From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)
timeFrame: from date of hospital discharge prior to randomization upto readmission days >1 and <31 days
measure: Number of COPD Exacerbation Events From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)
timeFrame: start of treatment to the last timepoint with information of clinical adverse outcome available,Up to 2 years
measure: Exposure of COPD Exacerbation Events From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)
timeFrame: start of treatment to the last timepoint with information of clinical adverse outcome available,Up to 2 years
measure: Number of All-cause Hospitalization Event From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)
timeFrame: from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years
measure: Exposure of All-cause Hospitalization Event From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)
timeFrame: from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years
measure: Time to Event: Time to Recovery (EXACT-PRO) From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)
timeFrame: from first drug administration to the last timepoint with information of EXACT-PRO, Up to 2 years
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: 205.478.00243 Boehringer Ingelheim Investigational Site
state: Alabama
city: Flagstaff
country: United States
facility: 205.478.00208 Boehringer Ingelheim Investigational Site
state: Arizona
city: Glendale
country: United States
facility: 205.478.00260 Boehringer Ingelheim Investigational Site
state: Arizona
city: Loma Linda
country: United States
facility: 205.478.00241 Boehringer Ingelheim Investigational Site
state: California
city: Long Beach
country: United States
facility: 205.478.00240 Boehringer Ingelheim Investigational Site
state: California
city: Torrance
country: United States
facility: 205.478.00237 Boehringer Ingelheim Investigational Site
state: California
city: Denver
country: United States
facility: 205.478.00231 Boehringer Ingelheim Investigational Site
state: Colorado
city: Danbury
country: United States
facility: 205.478.00209 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Glastonbury
country: United States
facility: 205.478.00250 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Hartford
country: United States
facility: 205.478.00229 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Jacksonville
country: United States
facility: 205.478.00200 Boehringer Ingelheim Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: 205.478.00212 Boehringer Ingelheim Investigational Site
state: Florida
city: Kissimmee
country: United States
facility: 205.478.00265 Boehringer Ingelheim Investigational Site
state: Florida
city: Lehigh Acres
country: United States
facility: 205.478.00246 Boehringer Ingelheim Investigational Site
state: Florida
city: Miami
country: United States
facility: 205.478.00248 Boehringer Ingelheim Investigational Site
state: Florida
city: Orlando
country: United States
facility: 205.478.00215 Boehringer Ingelheim Investigational Site
state: Florida
city: Saint Petersburg
country: United States
facility: 205.478.00261 Boehringer Ingelheim Investigational Site
state: Florida
city: Vero Beach
country: United States
facility: 205.478.00233 Boehringer Ingelheim Investigational Site
state: Florida
city: Austell
country: United States
facility: 205.478.00236 Boehringer Ingelheim Investigational Site
state: Georgia
city: Lawrenceville
country: United States
facility: 205.478.00205 Boehringer Ingelheim Investigational Site
state: Georgia
city: Evanston
country: United States
facility: 205.478.00225 Boehringer Ingelheim Investigational Site
state: Illinois
city: Iowa City
country: United States
facility: 205.478.00264 Boehringer Ingelheim Investigational Site
state: Iowa
city: Olathe
country: United States
facility: 205.478.00254 Boehringer Ingelheim Investigational Site
state: Kansas
city: Topeka
country: United States
facility: 205.478.00249 Boehringer Ingelheim Investigational Site
state: Kansas
city: Hazard
country: United States
facility: 205.478.00257 Boehringer Ingelheim Investigational Site
state: Kentucky
city: Lexington
country: United States
facility: 205.478.00234 Boehringer Ingelheim Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: 205.478.00242 Boehringer Ingelheim Investigational Site
state: Kentucky
city: Eunice
country: United States
facility: 205.478.00258 Boehringer Ingelheim Investigational Site
state: Louisiana
city: New Orleans
country: United States
facility: 205.478.00256 Boehringer Ingelheim Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: 205.478.00210 Boehringer Ingelheim Investigational Site
state: Maryland
city: Towson
country: United States
facility: 205.478.00220 Boehringer Ingelheim Investigational Site
state: Maryland
city: North Dartmouth
country: United States
facility: 205.478.00204 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Winston Salem
country: United States
facility: 205.478.00247 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Rochester
country: United States
facility: 205.478.00263 Boehringer Ingelheim Investigational Site
state: Minnesota
city: Chesterfield
country: United States
facility: 205.478.00201 Boehringer Ingelheim Investigational Site
state: Missouri
city: Kansas City
country: United States
facility: 205.478.00239 Boehringer Ingelheim Investigational Site
state: Missouri
city: Summit
country: United States
facility: 205.478.00227 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Bronx
country: United States
facility: 205.478.00253 Boehringer Ingelheim Investigational Site
state: New York
city: Chapel Hill
country: United States
facility: 205.478.00226 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: 205.478.00232 Boehringer Ingelheim Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: 205.478.00203 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Wyomissing
country: United States
facility: 205.478.00206 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Easley
country: United States
facility: 205.478.00219 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Arlington
country: United States
facility: 205.478.00222 Boehringer Ingelheim Investigational Site
state: Texas
city: Kingwood
country: United States
facility: 205.478.00235 Boehringer Ingelheim Investigational Site
state: Texas
city: McKinney
country: United States
facility: 205.478.00217 Boehringer Ingelheim Investigational Site
state: Texas
city: Temple
country: United States
facility: 205.478.00216 Boehringer Ingelheim Investigational Site
state: Texas
city: Falls Church
country: United States
facility: 205.478.00230 Boehringer Ingelheim Investigational Site
state: Virginia
city: Richmond
country: United States
facility: 205.478.00202 Boehringer Ingelheim Investigational Site
state: Virginia
city: Tacoma
country: United States
facility: 205.478.00224 Boehringer Ingelheim Investigational Site
state: Washington
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: