Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 1 of 3 for:    spiriva | cystic fibrosis
Previous Study | Return to List | Next Study

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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00737100
First received: August 15, 2008
Last updated: May 7, 2014
Last verified: January 2014

August 15, 2008
May 7, 2014
September 2008
April 2010   (final data collection date for primary outcome measure)
  • Percent Predicted FEV1 AUC0-4 Response at the End of Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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.
  • Percent Predicted FEV1 Trough Response at the End of Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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.
The coprimary endpoints for this trial are: Change from baseline in FEV1 AUC at the end of week 12 Change from baseline in trough FEV1 at the end of week 12 [ Time Frame: 12 weeks ]
Complete list of historical versions of study NCT00737100 on ClinicalTrials.gov Archive Site
  • Percent Predicted FVC AUC0-4 Response at the End of Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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.
  • Percent Predicted FVC Trough Response at the End of Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    Change from baseline in percent predicted trough Forced Vital Capacity (FVC). Calculated as percent predicted at week 12 minus percent predicted at baseline.
  • Pre-bronchodilator FEF25-75 Percent Predicted at the End of Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    Forced Expiratory Flow at 25-75% of vital capacity (FEF25-75). Calculated as percent predicted at week 12 minus percent predicted at baseline.
  • Change From Baseline in Residual Volume/Total Lung Capacity (RV/TLC) at the End of Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    Change from baseline in static lung hyperinflation as measured by RV/TLC. Calculated as percent predicted at week 12 minus percent predicted at baseline.
  • Respiratory and Systemic Symptoms Questionnaire (RSSQ) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Outcome measure description: The RSSQ questionnaire is used to determine the presence or absence of an exacerbation during the recall period.
  • Change From Baseline in CFQ Scores - Adult Group [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in CFQ Scores - Adolescents Group [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in CFQ Scores - Parent Questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    Ae0-4,ss represents the amount of tiotropium that is eliminated in urine from time 0 to 4 hours at steady state
  • 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 ] [ Designated as safety issue: No ]
    Cmax,ss represents the maximum measured concentration of tiotropium in plasma at steady state.
  • 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 ] [ Designated as safety issue: No ]
    Tmax,ss represents the time from dosing to the maximum concentration of tiotropium in plasma
  • 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) ] [ Designated as safety issue: No ]
    Clinical Relevant Abnormalities for Vital Signs and Laboratory evaluation. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Event.
Change from baseline in FVC AUC at the end of week 12 Change from baseline in trough FVC Change from baseline in prebronchodilator FEF25 to 75 percent predicted at the end of week 12 Proportion of patients with at least 1 pulmonary exacerbation [ Time Frame: 12 weeks ]
Not Provided
Not Provided
 
Safety and Efficacy of 12-wk Treatment With Two Doses of Tiotropium Respimat in Cystic Fibrosis
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.

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Cystic Fibrosis
  • Drug: Placebo Respimat
    patient to receive placebo matching active drug once daily
  • Drug: Tiotropium bromide 5 mcg
    patient to recieve high dose tiotropium once daily
  • Drug: tiotropium bromide-low dose-2.5mcg
    patient to receive low dose tiotropium once daily
  • Experimental: Tiotropium Respimat 2.5 mcg
    patient to receive low dose tiotropium once daily
    Intervention: Drug: tiotropium bromide-low dose-2.5mcg
  • Experimental: Tiotropium Respimat 5 mcg
    patient to receive high dose tiotropium once daily
    Intervention: Drug: Tiotropium bromide 5 mcg
  • Placebo Comparator: Placebo Respimat
    patient to receive placebo once daily
    Intervention: Drug: Placebo Respimat
Bradley JM, Koker P, Deng Q, Moroni-Zentgraf P, Ratjen F, Geller DE, Elborn JS; Tiotropium Cystic Fibrosis Study Group. Testing two different doses of tiotropium Respimat® in cystic fibrosis: phase 2 randomized trial results. PLoS One. 2014 Sep 4;9(9):e106195. doi: 10.1371/journal.pone.0106195. eCollection 2014.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
510
Not Provided
April 2010   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   France,   Germany,   Italy,   Netherlands,   New Zealand,   Portugal,   Russian Federation,   United Kingdom
 
NCT00737100
205.339, 2008-001156-43
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP