Tiotropium (18mcg) in Chronic Obstructive Pulmonary Disease (COPD) Patients With a Respiratory Infection

NCT ID: NCT01483625

Last Updated: 2014-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-12-31

Brief Summary

The aim of the study is to investigate whether the early introduction of maintenance bronchodilator therapy during an acute symptomatic episode of the disease shows benefits on the recovery of symptoms. It also represents an opportunity to identify COPD patients earlier in their disease state and start maintenance therapy, if appropriate.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

tiotropium 18mcg

active

Group Type: EXPERIMENTAL

tiotropium

Intervention Type: DRUG

18mcg

Placebo

placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo

Interventions

tiotropium

18mcg

Intervention Type: DRUG

Placebo

placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. All patients must sign an informed consent consistent with 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 patients 40 years of age or older.

3. Ability to independently read and understand English and/or Spanish.

4. Any self-reported history of smoking (e.g. = 100 cigarettes (~5 packs) during life-time).

5. Acute respiratory symptoms for up to 7 days

6. All patients must have a diagnosis of COPD, and must have an airway obstruction with a post-bronchodilator (Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC)) <0.7. The diagnosis of COPD can be made at Visit 1.

7. The clinical assessment of the enrolled patient in the judgement of the investigator supports the introduction of COPD maintenance therapy.

8. Patients must be able to inhale medication in a competent manner from the HandiHaler® device and from a metered dose inhaler (MDI)

Exclusion Criteria

1. Therapy with any long-acting bronchodilator, short-acting anticholinergic, inhaled corticosteroid or regular maintenance use (>14 consecutive days) of systemic corticosteroid (the latter for respiratory indications) during the previous 6 months (short course of systemic corticosteroid for up to 14 days for respiratory indications allowed); in case of use of systemic corticosteroid medication for other than respiratory conditions, then exclusion of unstable doses (i.e., less than six weeks on stable dose) or at doses in excess of the equivalent of 10 mg prednisolone-equivalent per day. In addition, daily use of short-acting beta2-agonist for more than a week prior to Visit 0 not allowed.

2. Significant diseases other than COPD. A significant disease is defined as a disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence the patient¿s ability to participate in the study.

3. A recent history (i.e., six months or less) of myocardial infarction. Patients being stable with a history of cardiac stents prior to six month are permitted.

4. Any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year.

5. Hospitalisation for cardiac failure (New York Heart Association (NYHA) Class III or IV) during the past year.

6. Any significant or new ECG findings at V1 as judged by the investigator, including, but not limited to signs of ischemia, arrhythmia, heart failure, or the report of chest pain.

7. Known active tuberculosis.

8. Current asthma (patient treated for asthma in the last 2 years), cystic fibrosis, clinical diagnosis of bronchiectasis, interstitial lung disease, or pulmonary thromboembolic disease.

9. A history of thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion no. 2.

10. Malignancy for which the patient has undergone resection, radiation, chemotherapy or biological treatments within the last year or is currently on active radiation therapy, chemotherapy or biological treatment. Patients with treated basal cell carcinoma are allowed.

11. At visit 0 or 1, a severe respiratory infection, e.g. pneumonia (as suspected by investigator), any condition or exacerbation requiring ER visit or hospitalization, need for oxygen treatment.

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

13. Treatment with any restricted pulmonary medication

14. Requirement of supplemental oxygen therapy for = 24 hours during the previous 6 months.

15. Known moderate to severe renal impairment.

16. Known narrow angle glaucoma.

17. Significant symptomatic prostatic hyperplasia or bladder-neck obstruction. Patients whose symptoms are controlled on treatment may be included.

18. 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 subdermal implants e.g., Norplant®) for at least three months prior to and for the duration of the trial.

19. Significant alcohol or drug abuse within the past 12 months.

20. Actively participating in a pulmonary rehabilitation program.

21. Previously randomized in this study or currently participating in another interventional study.

22. Visual impairment that as judged by the investigator does not allow the patient to independently read and complete the questionnaires and electronic diary (eDiary).

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

205.479.01017 Boehringer Ingelheim Investigational Site

Tucson, Arizona, United States

205.479.01036 Boehringer Ingelheim Investigational Site

Riverside, California, United States

205.479.01024 Boehringer Ingelheim Investigational Site

San Diego, California, United States

205.479.01043 Boehringer Ingelheim Investigational Site

DeLand, Florida, United States

205.479.01040 Boehringer Ingelheim Investigational Site

St. Petersburg, Florida, United States

205.479.01022 Boehringer Ingelheim Investigational Site

Chelsea, Michigan, United States

205.479.01041 Boehringer Ingelheim Investigational Site

Picayune, Mississippi, United States

205.479.01037 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

205.479.01005 Boehringer Ingelheim Investigational Site

Tabor City, North Carolina, United States

205.479.01008 Boehringer Ingelheim Investigational Site

Wilmington, North Carolina, United States

205.479.01003 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

205.479.01002 Boehringer Ingelheim Investigational Site

Pittsburgh, Pennsylvania, United States

205.479.01044 Boehringer Ingelheim Investigational Site

Tipton, Pennsylvania, United States

205.479.01006 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

205.479.01001 Boehringer Ingelheim Investigational Site

Columbia, South Carolina, United States

205.479.01007 Boehringer Ingelheim Investigational Site

Easley, South Carolina, United States

205.479.01026 Boehringer Ingelheim Investigational Site

Fort Mill, South Carolina, United States

205.479.01031 Boehringer Ingelheim Investigational Site

Gaffney, South Carolina, United States

205.479.01012 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

205.479.01048 Boehringer Ingelheim Investigational Site

Hodges, South Carolina, United States

205.479.01004 Boehringer Ingelheim Investigational Site

Spartanburg, South Carolina, United States

205.479.01019 Boehringer Ingelheim Investigational Site

Union, South Carolina, United States

205.479.01039 Boehringer Ingelheim Investigational Site

Rapid City, South Dakota, United States

205.479.01033 Boehringer Ingelheim Investigational Site

Chattanooga, Tennessee, United States

205.479.01028 Boehringer Ingelheim Investigational Site

Killeen, Texas, United States

205.479.01038 Boehringer Ingelheim Investigational Site

Ettrick, Virginia, United States

205.479.01047 Boehringer Ingelheim Investigational Site

Norfolk, Virginia, United States

Countries

United States

Other Identifiers

205.479

Identifier Type: -

Identifier Source: org_study_id