Investigate the Impact of Early Treatment Initiation With Tiotropium in Patients Recovering From Hospitalization for an Acute COPD Exacerbation 1

NCT01663987 | Completed Phase 4 Results

• 1 other identifier: 205.477
• Study Type: interventional
• Target: 79
• Locations: 2 countries
• Sites: 50

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)

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (2)

• Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug

  Change from baseline in trough forced expiratory volume in 1 second (FEV1) at 12 weeks on study medication. Trough FEV1 is defined as FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after the last inhalation of drug.

  Baseline and 12 weeks

• Percentage of Patients With Next Adverse Clinical Outcome Event From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)

  Percentage of patients with next adverse clinical outcome event occured during the study, defined as the combined endpoint of chronic obstructive pulmonary disease (COPD) exacerbations per Boehringer Ingelheim (BI) definition, all-cause re-hospitalization, or all-cause mortality. Time to the next adverse clinical outcome event from the two twin trials, was defined as a primary endpoint but was not analysed numerically, so this endpoint is presented instead. This endpoint was analysed using combined data, as specified in the analysis plan.

  From first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years

Secondary Outcomes (10)

• Change From Baseline of Trough FVC at 12 Weeks on Study Drug

  Baseline and 12 weeks

• Percentage of Patients With Adverse Clinical Event on Study

  From first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years

• 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)

  Baseline and 12 weeks

• Change From Baseline of Trough FVC at 12 Weeks From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)

  Baseline and 12 weeks

• Percentage of Patients With COPD Exacerbation From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)

  from first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years

Study Arms (2)

18 mcg tiotropium

ACTIVE COMPARATOR

Patient to receive one tiotropium bromide inhalation powder capsule daily (in the morning) via HandiHaler

Drug: tiotropium bromide

Placebo

PLACEBO COMPARATOR

Patient to receive one placebo capsule daily (in the morning) identical to those containing tiotropium bromide inhalation powder via HandiHaler

Drug: Placebo

Interventions

tiotropium bromide DRUG

18 mcg once a day (QD)

18 mcg tiotropium

Placebo DRUG

once a day (QD)

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.
• Male or female subjects 40 years of age or older.
• 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.
• Patient reported hospital length of stay and discharge date (confirmed with hospital discharge summary/hospital records; however, medical record confirmation may occur following randomization).
• Discharged from the hospital =10 days from date of randomization.
• 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.
• 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).

You may not qualify if:

• 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
• 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.
• A documented history of myocardial infarction during the hospitalization preceding randomization. Subjects being stable with a history of cardiac stents are permitted.
• Any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year.
• 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.
• \. 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.
• \. Hospitalization for cardiac failure (New York Heart Association (NYHA) class III or IV) during the hospitalization preceding randomization.
• \. Known hypersensitivity to anticholinergic drugs, lactose, or any other components of the HandiHaler® or MDI inhalation solution delivery system.
• \. 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.
• \. Significant alcohol or drug abuse within the past 12 months. 15. Previously randomized in this study or currently participating in another interventional study.
• \. Visual impairment that as judged by the investigator does not allow the subject to independently read and complete the questionnaires and eDiary.
• \. Any significant or new ECG findings at Visit 1 as judged by the investigator, including, but not limited to signs of acute ischemia, arrhythmia.
• \. Treatment with any restricted pulmonary medication. 19. Residing in an assisted living facility.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (50)

205.477.001039 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

205.477.001050 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

205.477.001021 Boehringer Ingelheim Investigational Site

Florence, Alabama, United States

Location

205.477.001046 Boehringer Ingelheim Investigational Site

Fountain Valley, California, United States

Location

205.477.001052 Boehringer Ingelheim Investigational Site

Sacramento, California, United States

Location

205.477.001059 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Location

205.477.001009 Boehringer Ingelheim Investigational Site

Stamford, Connecticut, United States

Location

205.477.001040 Boehringer Ingelheim Investigational Site

Waterbury, Connecticut, United States

Location

205.477.001051 Boehringer Ingelheim Investigational Site

Brandon, Florida, United States

Location

205.477.001044 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Location

205.477.001037 Boehringer Ingelheim Investigational Site

Eustis, Florida, United States

Location

205.477.001017 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

205.477.001063 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

205.477.001001 Boehringer Ingelheim Investigational Site

St. Petersburg, Florida, United States

Location

205.477.001004 Boehringer Ingelheim Investigational Site

Decatur, Georgia, United States

Location

205.477.001012 Boehringer Ingelheim Investigational Site

Duluth, Georgia, United States

Location

205.477.001064 Boehringer Ingelheim Investigational Site

Belleville, Illinois, United States

Location

205.477.001038 Boehringer Ingelheim Investigational Site

Muncie, Indiana, United States

Location

205.477.001007 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

Location

205.477.001014 Boehringer Ingelheim Investigational Site

Columbia, Maryland, United States

Location

205.477.001018 Boehringer Ingelheim Investigational Site

Livonia, Michigan, United States

Location

205.477.001068 Boehringer Ingelheim Investigational Site

Union, New Jersey, United States

Location

205.477.001035 Boehringer Ingelheim Investigational Site

Cooperstown, New York, United States

Location

205.477.001023 Boehringer Ingelheim Investigational Site

New York, New York, United States

Location

205.477.001061 Boehringer Ingelheim Investigational Site

Staten Island, New York, United States

Location

205.477.001027 Boehringer Ingelheim Investigational Site

Burlington, North Carolina, United States

Location

205.477.001032 Boehringer Ingelheim Investigational Site

Huntersville, North Carolina, United States

Location

205.477.001020 Boehringer Ingelheim Investigational Site

Seneca, North Carolina, United States

Location

205.477.001034 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

205.477.001053 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Location

205.477.001011 Boehringer Ingelheim Investigational Site

Dayton, Ohio, United States

Location

205.477.001057 Boehringer Ingelheim Investigational Site

Tulsa, Oklahoma, United States

Location

205.477.001006 Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

Location

205.477.001083 Boehringer Ingelheim Investigational Site

Downingtown, Pennsylvania, United States

Location

205.477.001031 Boehringer Ingelheim Investigational Site

Monroeville, Pennsylvania, United States

Location

205.477.001028 Boehringer Ingelheim Investigational Site

Anderson, South Carolina, United States

Location

205.477.001019 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Location

205.477.001010 Boehringer Ingelheim Investigational Site

Fort Mill, South Carolina, United States

Location

205.477.001025 Boehringer Ingelheim Investigational Site

Gaffney, South Carolina, United States

Location

205.477.001002 Boehringer Ingelheim Investigational Site

Rock Hill, South Carolina, United States

Location

205.477.001026 Boehringer Ingelheim Investigational Site

Spartanburg, South Carolina, United States

Location

205.477.001015 Boehringer Ingelheim Investigational Site

Union, South Carolina, United States

Location

205.477.001013 Boehringer Ingelheim Investigational Site

Nashville, Tennessee, United States

Location

205.477.001022 Boehringer Ingelheim Investigational Site

Corsicana, Texas, United States

Location

205.477.001055 Boehringer Ingelheim Investigational Site

Fort Worth, Texas, United States

Location

205.477.001054 Boehringer Ingelheim Investigational Site

Katy, Texas, United States

Location

205.477.001062 Boehringer Ingelheim Investigational Site

Tyler, Texas, United States

Location

205.477.001030 Boehringer Ingelheim Investigational Site

Abingdon, Virginia, United States

Location

205.477.001008 Boehringer Ingelheim Investigational Site

Roanoke, Virginia, United States

Location

205.477.001043 Boehringer Ingelheim Investigational Site

San Juan, Puerto Rico

Location

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

Limitations and Caveats

The original protocol planned to randomize 604 subjects, however this was not reached due to low patient enrollment. All results are descriptive only.

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2012
• First Posted: August 14, 2012
• Study Start: August 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: October 17, 2018
• Results First Posted: July 9, 2015

Record last verified: 2018-09

Locations

US (49); PR (1)