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

NCT01483625 | Completed Phase 4 Results

• 1 other identifier: 205.479
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 27

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

Outcome Measures

Primary Outcomes (1)

• Trough FEV1 After 12 Weeks on Study Drug

  The primary endpoint was trough forced expiratory volume in 1 second (FEV1) after 12 weeks on study drug. Trough forced expiratory volume in 1 second (FEV1)was defined as the FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after the last inhalation of study drug.

  12 weeks

Secondary Outcomes (5)

• Time to Recovery From Acute Respiratory Symptoms

  12 weeks

• Trough FVC (in Litres) at 12 Weeks

  12 weeks

• Responder Status at Week 4 Clinic Visit

  4 weeks

• Responder Status at Week 12 Clinic Visit

  12 weeks

• Weekly Rescue Medication Use Over the 12 Weeks of Study

  12 weeks

Study Arms (2)

tiotropium 18mcg

EXPERIMENTAL

active

Drug: tiotropium

Placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

tiotropium DRUG

18mcg

tiotropium 18mcg

Placebo DRUG

placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.
• Male or female patients 40 years of age or older.
• Ability to independently read and understand English and/or Spanish.
• Any self-reported history of smoking (e.g. = 100 cigarettes (\~5 packs) during life-time).
• Acute respiratory symptoms for up to 7 days
• 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.
• The clinical assessment of the enrolled patient in the judgement of the investigator supports the introduction of COPD maintenance therapy.
• Patients must be able to inhale medication in a competent manner from the HandiHaler® device and from a metered dose inhaler (MDI)

You may not qualify if:

• 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.
• 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.
• Any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year.
• Hospitalisation for cardiac failure (New York Heart Association (NYHA) Class III or IV) during the past year.
• 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.
• Known active tuberculosis.
• Current asthma (patient treated for asthma in the last 2 years), cystic fibrosis, clinical diagnosis of bronchiectasis, interstitial lung disease, or pulmonary thromboembolic disease.
• 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.
• 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.
• Known hypersensitivity to anticholinergic drugs, lactose, or any other components of the HandiHaler® or MDI inhalation solution delivery system.
• Treatment with any restricted pulmonary medication
• Requirement of supplemental oxygen therapy for = 24 hours during the previous 6 months.
• Known moderate to severe renal impairment.
• Known narrow angle glaucoma.
• Significant symptomatic prostatic hyperplasia or bladder-neck obstruction. Patients whose symptoms are controlled on treatment may be included.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (27)

205.479.01017 Boehringer Ingelheim Investigational Site

Tucson, Arizona, United States

Location

205.479.01036 Boehringer Ingelheim Investigational Site

Riverside, California, United States

Location

205.479.01024 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Location

205.479.01043 Boehringer Ingelheim Investigational Site

DeLand, Florida, United States

Location

205.479.01040 Boehringer Ingelheim Investigational Site

St. Petersburg, Florida, United States

Location

205.479.01022 Boehringer Ingelheim Investigational Site

Chelsea, Michigan, United States

Location

205.479.01041 Boehringer Ingelheim Investigational Site

Picayune, Mississippi, United States

Location

205.479.01037 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Location

205.479.01005 Boehringer Ingelheim Investigational Site

Tabor City, North Carolina, United States

Location

205.479.01008 Boehringer Ingelheim Investigational Site

Wilmington, North Carolina, United States

Location

205.479.01003 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

205.479.01002 Boehringer Ingelheim Investigational Site

Pittsburgh, Pennsylvania, United States

Location

205.479.01044 Boehringer Ingelheim Investigational Site

Tipton, Pennsylvania, United States

Location

205.479.01006 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Location

205.479.01001 Boehringer Ingelheim Investigational Site

Columbia, South Carolina, United States

Location

205.479.01007 Boehringer Ingelheim Investigational Site

Easley, South Carolina, United States

Location

205.479.01026 Boehringer Ingelheim Investigational Site

Fort Mill, South Carolina, United States

Location

205.479.01031 Boehringer Ingelheim Investigational Site

Gaffney, South Carolina, United States

Location

205.479.01012 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

Location

205.479.01048 Boehringer Ingelheim Investigational Site

Hodges, South Carolina, United States

Location

205.479.01004 Boehringer Ingelheim Investigational Site

Spartanburg, South Carolina, United States

Location

205.479.01019 Boehringer Ingelheim Investigational Site

Union, South Carolina, United States

Location

205.479.01039 Boehringer Ingelheim Investigational Site

Rapid City, South Dakota, United States

Location

205.479.01033 Boehringer Ingelheim Investigational Site

Chattanooga, Tennessee, United States

Location

205.479.01028 Boehringer Ingelheim Investigational Site

Killeen, Texas, United States

Location

205.479.01038 Boehringer Ingelheim Investigational Site

Ettrick, Virginia, United States

Location

205.479.01047 Boehringer Ingelheim Investigational Site

Norfolk, Virginia, United States

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

Results Point of Contact

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

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
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2011
• First Posted: December 1, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 9, 2014
• Results First Posted: April 10, 2014

Record last verified: 2014-03

Locations

US (27)