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

Phase 4

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: Drug: Placebo
Drug: tiotropium

Registration Number: NCT01483625

Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 140

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo
tiotropium 18mcg	tiotropium	active

Primary Outcome Measures

Name	Time	Method
Trough FEV1 After 12 Weeks on Study Drug	12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Time to Recovery From Acute Respiratory Symptoms	12 weeks	Time to recovery was assessed with the EXACT-PRO questionnaire tool. The EXACT-PRO was designed to collect data to quantify frequency, severity, and duration of exacerbations in patients with COPD including the onset of and the recovery from COPD exacerbations. The EXACT-PRO is a 14-item questionnaire. Each attribute or item was assessed on a five- or six-point ordinal scale and summed to yield a total score that was converted to a 0-100 scale, with higher scores indicating a more severe health state or exacerbation. The EXACT-PRO was answered by the patients on a daily basis in the evening.
Trough FVC (in Litres) at 12 Weeks	12 weeks	The trough Forced Vital Capacity (FVC) was defined as the FVC measurement prior to the next dosing of study drug and approximately 24 hours after the last inhalation of study drug.
Responder Status at Week 4 Clinic Visit	4 weeks	Responder status was determined at each clinic visit. The number and percentage of subjects in each of the following 3 classes were presented: * Subject recovered without change of therapy (subjects who received an additional course of antibiotics and/or systemic corticosteroids starting after Visit 1 were not included). * Subject recovered but had a change in therapy (subject received an additional course of antibiotics and/or systemic corticosteroids starting after Visit 1). * Subject did not recover.
Responder Status at Week 12 Clinic Visit	12 weeks	Responder status was determined at each clinic visit. The number and percentage of subjects in each of the following 3 classes were presented: * Subject recovered without change of therapy (subjects who received an additional course of antibiotics and/or systemic corticosteroids starting after Visit 1 were not included). * Subject recovered but had a change in therapy (subject received an additional course of antibiotics and/or systemic corticosteroids starting after Visit 1). * Subject did not recover.
Weekly Rescue Medication Use Over the 12 Weeks of Study	12 weeks	Daily rescue albuterol use was recorded in the diary in response to the following question: How many puffs of rescue medication did you use during the last 24 hours? The weekly rescue medication use was derived by summing the daily uses over the 12 weeks and dividing this total by 12 weeks.

Trial Locations

Locations (27): 205.479.01037 Boehringer Ingelheim Investigational Site
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St. Louis, Missouri, United States
205.479.01007 Boehringer Ingelheim Investigational Site
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Easley, South Carolina, United States
205.479.01002 Boehringer Ingelheim Investigational Site
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Pittsburgh, Pennsylvania, United States
205.479.01001 Boehringer Ingelheim Investigational Site
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Columbia, South Carolina, United States
205.479.01003 Boehringer Ingelheim Investigational Site
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Cincinnati, Ohio, United States
205.479.01024 Boehringer Ingelheim Investigational Site
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San Diego, California, United States
205.479.01006 Boehringer Ingelheim Investigational Site
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Charleston, South Carolina, United States
205.479.01026 Boehringer Ingelheim Investigational Site
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Fort Mill, South Carolina, United States
205.479.01031 Boehringer Ingelheim Investigational Site
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Gaffney, South Carolina, United States
205.479.01004 Boehringer Ingelheim Investigational Site
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Spartanburg, South Carolina, United States
205.479.01033 Boehringer Ingelheim Investigational Site
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Chattanooga, Tennessee, United States
205.479.01019 Boehringer Ingelheim Investigational Site
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Union, South Carolina, United States
205.479.01041 Boehringer Ingelheim Investigational Site
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Picayune, Mississippi, United States
205.479.01036 Boehringer Ingelheim Investigational Site
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Riverside, California, United States
205.479.01043 Boehringer Ingelheim Investigational Site
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DeLand, Florida, United States
205.479.01039 Boehringer Ingelheim Investigational Site
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Rapid City, South Dakota, United States
205.479.01047 Boehringer Ingelheim Investigational Site
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Norfolk, Virginia, United States
205.479.01005 Boehringer Ingelheim Investigational Site
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Tabor City, North Carolina, United States
205.479.01044 Boehringer Ingelheim Investigational Site
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Tipton, Pennsylvania, United States
205.479.01040 Boehringer Ingelheim Investigational Site
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St. Petersburg, Florida, United States
205.479.01017 Boehringer Ingelheim Investigational Site
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Tucson, Arizona, United States
205.479.01022 Boehringer Ingelheim Investigational Site
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Chelsea, Michigan, United States
205.479.01008 Boehringer Ingelheim Investigational Site
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Wilmington, North Carolina, United States
205.479.01012 Boehringer Ingelheim Investigational Site
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Greenville, South Carolina, United States
205.479.01048 Boehringer Ingelheim Investigational Site
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Hodges, South Carolina, United States
205.479.01038 Boehringer Ingelheim Investigational Site
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Ettrick, Virginia, United States
205.479.01028 Boehringer Ingelheim Investigational Site
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Killeen, Texas, United States