Clinical trial NCT01663987: Investigate the Impact of Early Treatment Initiation With Tiotropium in Patients Recovering From Hospitalization for an Acute COPD Exacerbation 1
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 1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2012-08-14
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 1)


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 205.477 (NCT01663987) and 205.478 (NCT01662986)
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 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 205.477 (NCT01663987) and 205.478 (NCT01662986)
timeFrame: Baseline and 12 weeks
measure: Change From Baseline of Trough FVC at 12 Weeks From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)
timeFrame: Baseline and 12 weeks
measure: Percentage of Patients With COPD Exacerbation From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)
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 205.477 (NCT01663987) and 205.478 (NCT01662986)
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 Readmission Rates Outcome Event From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)
timeFrame: from date of hospital discharge prior to randomization up to readmission days >1 and <31 days
measure: Number of COPD Exacerbation Events From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)
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 205.477 (NCT01663987) and 205.478 (NCT01662986)
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 205.477 (NCT01663987) and 205.478 (NCT01662986)
timeFrame: From first drug administration to the last timepoint with information of EXACT-PRO, up to 2 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 205.477.001039 Boehringer Ingelheim Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: 205.477.001050 Boehringer Ingelheim Investigational Site
state: Alabama
city: Florence
country: United States
facility: 205.477.001021 Boehringer Ingelheim Investigational Site
state: Alabama
city: Fountain Valley
country: United States
facility: 205.477.001046 Boehringer Ingelheim Investigational Site
state: California
city: Sacramento
country: United States
facility: 205.477.001052 Boehringer Ingelheim Investigational Site
state: California
city: San Diego
country: United States
facility: 205.477.001059 Boehringer Ingelheim Investigational Site
state: California
city: Stamford
country: United States
facility: 205.477.001009 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Waterbury
country: United States
facility: 205.477.001040 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Brandon
country: United States
facility: 205.477.001051 Boehringer Ingelheim Investigational Site
state: Florida
city: Clearwater
country: United States
facility: 205.477.001044 Boehringer Ingelheim Investigational Site
state: Florida
city: Eustis
country: United States
facility: 205.477.001037 Boehringer Ingelheim Investigational Site
state: Florida
city: Miami
country: United States
facility: 205.477.001017 Boehringer Ingelheim Investigational Site
state: Florida
city: Miami
country: United States
facility: 205.477.001063 Boehringer Ingelheim Investigational Site
state: Florida
city: Saint Petersburg
country: United States
facility: 205.477.001001 Boehringer Ingelheim Investigational Site
state: Florida
city: Decatur
country: United States
facility: 205.477.001004 Boehringer Ingelheim Investigational Site
state: Georgia
city: Duluth
country: United States
facility: 205.477.001012 Boehringer Ingelheim Investigational Site
state: Georgia
city: Belleville
country: United States
facility: 205.477.001064 Boehringer Ingelheim Investigational Site
state: Illinois
city: Muncie
country: United States
facility: 205.477.001038 Boehringer Ingelheim Investigational Site
state: Indiana
city: Baltimore
country: United States
facility: 205.477.001007 Boehringer Ingelheim Investigational Site
state: Maryland
city: Columbia
country: United States
facility: 205.477.001014 Boehringer Ingelheim Investigational Site
state: Maryland
city: Livonia
country: United States
facility: 205.477.001018 Boehringer Ingelheim Investigational Site
state: Michigan
city: Union
country: United States
facility: 205.477.001068 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Cooperstown
country: United States
facility: 205.477.001035 Boehringer Ingelheim Investigational Site
state: New York
city: New York
country: United States
facility: 205.477.001023 Boehringer Ingelheim Investigational Site
state: New York
city: Staten Island
country: United States
facility: 205.477.001061 Boehringer Ingelheim Investigational Site
state: New York
city: Burlington
country: United States
facility: 205.477.001027 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Huntersville
country: United States
facility: 205.477.001032 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Seneca
country: United States
facility: 205.477.001020 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: 205.477.001034 Boehringer Ingelheim Investigational Site
state: Ohio
city: Columbus
country: United States
facility: 205.477.001053 Boehringer Ingelheim Investigational Site
state: Ohio
city: Dayton
country: United States
facility: 205.477.001011 Boehringer Ingelheim Investigational Site
state: Ohio
city: Tulsa
country: United States
facility: 205.477.001057 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Portland
country: United States
facility: 205.477.001006 Boehringer Ingelheim Investigational Site
state: Oregon
city: Downingtown
country: United States
facility: 205.477.001083 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Monroeville
country: United States
facility: 205.477.001031 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Anderson
country: United States
facility: 205.477.001028 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Charleston
country: United States
facility: 205.477.001019 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Fort Mill
country: United States
facility: 205.477.001010 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Gaffney
country: United States
facility: 205.477.001025 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Rock Hill
country: United States
facility: 205.477.001002 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: 205.477.001026 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Union
country: United States
facility: 205.477.001015 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Nashville
country: United States
facility: 205.477.001013 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Corsicana
country: United States
facility: 205.477.001022 Boehringer Ingelheim Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: 205.477.001055 Boehringer Ingelheim Investigational Site
state: Texas
city: Katy
country: United States
facility: 205.477.001054 Boehringer Ingelheim Investigational Site
state: Texas
city: Tyler
country: United States
facility: 205.477.001062 Boehringer Ingelheim Investigational Site
state: Texas
city: Abingdon
country: United States
facility: 205.477.001030 Boehringer Ingelheim Investigational Site
state: Virginia
city: Roanoke
country: United States
facility: 205.477.001008 Boehringer Ingelheim Investigational Site
state: Virginia
city: San Juan
country: Puerto Rico
facility: 205.477.001043 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: