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

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ClinicalTrials.gov Identifier: NCT00737100
Recruitment Status : Completed
First Posted : August 18, 2008
Results First Posted : April 13, 2011
Last Update Posted : May 16, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: Placebo Respimat Drug: Tiotropium bromide 5 mcg Drug: tiotropium bromide-low dose-2.5mcg Phase 2

Expanded Access : Boehringer Ingelheim has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 510 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Parallel Group Study to Investigate the Safety and Efficacy of Two Doses of Tiotropium Bromide (2.5 mcg and 5 mcg) Administered Once Daily Via the Respimat Device for 12 Weeks in Patients With Cystic Fibrosis.
Study Start Date : September 2008
Actual Primary Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Tiotropium Respimat 2.5 mcg
patient to receive low dose tiotropium once daily
 Drug: tiotropium bromide-low dose-2.5mcg
patient to receive low dose tiotropium once daily
Experimental: Tiotropium Respimat 5 mcg
patient to receive high dose tiotropium once daily
 Drug: Tiotropium bromide 5 mcg
patient to recieve high dose tiotropium once daily
Placebo Comparator: Placebo Respimat
patient to receive placebo once daily
 Drug: Placebo Respimat
patient to receive placebo matching active drug once daily


Outcome Measures
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Primary Outcome Measures :
  1. Percent Predicted FEV1 AUC0-4 Response at the End of Week 12 [ Time Frame: Baseline, 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.

  2. Percent Predicted FEV1 Trough Response at the End of Week 12 [ Time Frame: Baseline, 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.


Secondary Outcome Measures :
  1. Percent Predicted FVC AUC0-4 Response at the End of Week 12 [ Time Frame: Baseline, 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.

  2. Percent Predicted FVC Trough Response at the End of Week 12 [ Time Frame: Baseline, 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.

  3. Pre-bronchodilator FEF25-75 Percent Predicted at the End of Week 12 [ Time Frame: Baseline, 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.

  4. Change From Baseline in Residual Volume/Total Lung Capacity (RV/TLC) at the End of Week 12 [ Time Frame: Baseline, 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.

  5. Respiratory and Systemic Symptoms Questionnaire (RSSQ) [ Time Frame: 12 weeks ]
    Outcome measure description: The RSSQ questionnaire is used to determine the presence or absence of an exacerbation during the recall period.

  6. Change From Baseline in CFQ Scores - Adult Group [ Time Frame: 12 weeks ]
    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.

  7. Change From Baseline in CFQ Scores - Adolescents Group [ Time Frame: 12 weeks ]
    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.

  8. Change From Baseline in CFQ Scores - Parent Questionnaire [ Time Frame: 12 weeks ]
    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.

  9. Amount of Tiotropium Eliminated in Urine From 0 to 4 Hours at Steady State (Ae0-4,ss) [ Time Frame: pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose ]
    Ae0-4,ss represents the amount of tiotropium that is eliminated in urine from time 0 to 4 hours at steady state

  10. Maximum Measured Concentration at Steady State (Cmax,ss) [ Time Frame: pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose ]
    Cmax,ss represents the maximum measured concentration of tiotropium in plasma at steady state.

  11. Time From Dosing to the Maximum Concentration (Tmax,ss) [ Time Frame: pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose ]
    Tmax,ss represents the time from dosing to the maximum concentration of tiotropium in plasma

  12. Clinical Relevant Abnormalities for Vital Signs and Laboratory Evaluation [ Time Frame: From first drug administration until 30 days after last drug administration (up to 121 days) ]
    Clinical Relevant Abnormalities for Vital Signs and Laboratory evaluation. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Event.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00737100


Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00737100    
Other Study ID Numbers: 205.339
2008-001156-43 ( EudraCT Number: EudraCT )
First Posted: August 18, 2008    Key Record Dates
Results First Posted: April 13, 2011
Last Update Posted: May 16, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Bromides
Tiotropium Bromide
Bronchodilator Agents
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants