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Completed

NCT Number: NCT00737100

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

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

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

205.339.100 Boehringer Ingelheim Investigational Site, Westmead, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female patients
  • Diagnosis of Cystic Fibrosis (positive sweat chloride test or two identifiable mutations)
  • Pre-bronchodilator FEV1 greater/equal 25% of predicted values

Exclusion criteria

  • Significant history of allergy/hypersensitivity
  • Hypersensitivity to study drug
  • Participation in another trial
  • Female patients who are pregnant or lactating
  • Female patients of childbearing potential
  • Patients who have started a new medication for CF within 4 weeks of screening
  • Patients with known substance abuse
  • Clinically significant disease other than CF

Treatment and study plan

Placebo Respimat

Drug

patient to receive placebo matching active drug once daily

Tiotropium bromide 5 mcg

Drug

patient to recieve high dose tiotropium once daily

tiotropium bromide-low dose-2.5mcg

Drug

patient to receive low dose tiotropium once daily

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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.

Important dates

Study start
2008
Primary completion
2010
First posted
Aug 18, 2008
Registry last updated
May 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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