Safety and Efficacy of 12-wk Treatment With Two Doses of Tiotropium Respimat in Cystic Fibrosis

Boehringer Ingelheim510 enrolled

Overview

This study evaluates the effects of 12-week treatment with two doses of tiotropium bromide (2.5 mcg q.d. and 5 mcg q.d.) compared to placebo administered via the Respimat device on lung function in patients with Cystic Fibrosis. The selection of the optimal dose will be based on bronchodilator efficacy, safety evaluations and pharmacokinetic evaluations

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

510

Conditions

Cystic Fibrosis

Interventions

Placebo RespimatDRUG

patient to receive placebo matching active drug once daily

Tiotropium bromide 5 mcgDRUG

patient to recieve high dose tiotropium once daily

tiotropium bromide-low dose-2.5mcgDRUG

patient to receive low dose tiotropium once daily

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion criteria: 1. Male or female patients 2. Diagnosis of Cystic Fibrosis (positive sweat chloride test or two identifiable mutations) 3. Pre-bronchodilator FEV1 greater/equal 25% of predicted values Exclusion criteria: 1. Significant history of allergy/hypersensitivity 2. Hypersensitivity to study drug 3. Participation in another trial 4. Female patients who are pregnant or lactating 5. Female patients of childbearing potential 6. Patients who have started a new medication for CF within 4 weeks of screening 7. Patients with known substance abuse 8. Clinically significant disease other than CF

Locations (107)

Outcomes

Primary Outcomes

Percent Predicted FEV1 AUC0-4 Response at the End of Week 12

Outcome measure description: Change from baseline in percent predicted Forced Expiratory Volume in one second (FEV1) Area Under the Curve from 0 to 4 hours (AUC0-4). Calculated as percent predicted at week 12 minus percent predicted at baseline.

Time frame: Baseline, Week 12

Percent Predicted FEV1 Trough Response at the End of Week 12

Outcome measure description: Change from baseline in percent predicted trough Forced Expiratory Volume in one second. Calculated as percent predicted at week 12 minus percent predicted at baseline.

Time frame: Baseline, Week 12

Secondary Outcomes

Percent Predicted FVC AUC0-4 Response at the End of Week 12

Change from baseline in percent predicted Forced Vital Capacity (FVC) Area Under the Curve from 0 to 4 hours (AUC0-4). Calculated as percent predicted at week 12 minus percent predicted at baseline.

Time frame: Baseline, Week 12

Percent Predicted FVC Trough Response at the End of Week 12

Change from baseline in percent predicted trough Forced Vital Capacity (FVC). Calculated as percent predicted at week 12 minus percent predicted at baseline.

Time frame: Baseline, Week 12

Pre-bronchodilator FEF25-75 Percent Predicted at the End of Week 12

Forced Expiratory Flow at 25-75% of vital capacity (FEF25-75). Calculated as percent predicted at week 12 minus percent predicted at baseline.

Time frame: Baseline, Week 12

Change From Baseline in Residual Volume/Total Lung Capacity (RV/TLC) at the End of Week 12

Change from baseline in static lung hyperinflation as measured by RV/TLC. Calculated as percent predicted at week 12 minus percent predicted at baseline.

Data from ClinicalTrials.gov

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205.339.006 Boehringer Ingelheim Investigational Site

Tucson, Arizona, United States

205.339.019 Boehringer Ingelheim Investigational Site

San Diego, California, United States

205.339.023 Boehringer Ingelheim Investigational Site

Jacksonville, Florida, United States

205.339.021 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

205.339.030 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

205.339.031 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

205.339.014 Boehringer Ingelheim Investigational Site

Indianapolis, Indiana, United States

205.339.022 Boehringer Ingelheim Investigational Site

Indianapolis, Indiana, United States

205.339.013 Boehringer Ingelheim Investigational Site

South Bend, Indiana, United States

205.339.001 Boehringer Ingelheim Investigational Site

Iowa City, Iowa, United States

...and 97 more locations

Time frame: Baseline, Week 12

Respiratory and Systemic Symptoms Questionnaire (RSSQ)

Outcome measure description: The RSSQ questionnaire is used to determine the presence or absence of an exacerbation during the recall period.

Time frame: 12 weeks

Change From Baseline in CFQ Scores - Adult Group

The Cystic Fibrosis questionnaire (CFQ) is a disease-specific instrument that measures health-related quality of life (HRQOL) for adults with CF. This validation questionnaire consists of 50 items on generic and disease-specific scales. The scores range from 0 to 100, with higher scores indicating better health.

Time frame: 12 weeks

Change From Baseline in CFQ Scores - Adolescents Group

The Cystic Fibrosis questionnaire (CFQ) is a disease-specific instrument that measures health-related quality of life (HRQOL) for adolescents (age 6-13) with CF. This validation questionnaire consists of 50 items on generic and disease-specific scales. The scores range from 0 to 100, with higher scores indicating better health.

Time frame: 12 weeks

Change From Baseline in CFQ Scores - Parent Questionnaire

The Cystic Fibrosis questionnaire (CFQ) is a disease-specific instrument that measures health-related quality of life (HRQOL) for adolescents with CF - parent questionnaire. This validation questionnaire consists of 50 items on generic and disease-specific scales. The scores range from 0 to 100, with higher scores indicating better health.

Time frame: 12 weeks

Amount of Tiotropium Eliminated in Urine From 0 to 4 Hours at Steady State (Ae0-4,ss)

Ae0-4,ss represents the amount of tiotropium that is eliminated in urine from time 0 to 4 hours at steady state

Time frame: pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose

Maximum Measured Concentration at Steady State (Cmax,ss)

Cmax,ss represents the maximum measured concentration of tiotropium in plasma at steady state.

Time frame: pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose

Time From Dosing to the Maximum Concentration (Tmax,ss)

Tmax,ss represents the time from dosing to the maximum concentration of tiotropium in plasma

Time frame: pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose

Clinical Relevant Abnormalities for Vital Signs and Laboratory Evaluation

Clinical Relevant Abnormalities for Vital Signs and Laboratory evaluation. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Event.

Time frame: From first drug administration until 30 days after last drug administration (up to 121 days)