Phase 2
Completed N=510
Safety and Efficacy of 12-wk Treatment With Two Doses of Tiotropium Respimat in Cystic Fibrosis
Source: ClinicalTrials.gov NCT00737100 ↗Enrolled (actual)
510
Serious AEs
13.7%
Results posted
Apr 2011
Primary outcomePrimary: Percent Predicted FEV1 AUC0-4 Response at the End of Week 12 — -1.74; 1.20; 1.65 Percentage change — p=0.001
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Predicted FEV1 AUC0-4 Response at the End of Week 12 |
-1.74; 1.20; 1.65 | 0.001 sig |
| PRIMARY Percent Predicted FEV1 Trough Response at the End of Week 12 |
-1.44; 0.81; 0.78 | 0.0184 sig |
| SECONDARY Percent Predicted FVC AUC0-4 Response at the End of Week 12 |
-1.30; 0.53; 1.81 | 0.0756 |
| SECONDARY Percent Predicted FVC Trough Response at the End of Week 12 |
-0.39; 0.47; 0.81 | 0.3857 |
| SECONDARY Pre-bronchodilator FEF25-75 Percent Predicted at the End of Week 12 |
-1.40; 2.78; 3.94 | 0.0363 sig |
| SECONDARY Change From Baseline in Residual Volume/Total Lung Capacity (RV/TLC) at the End of Week 12 |
-0.01; 0.00; 0.04 | 0.7414 |
| SECONDARY Respiratory and Systemic Symptoms Questionnaire (RSSQ) |
16; 13; 12; 151; 153; 163 | 0.8515 |
| SECONDARY Change From Baseline in CFQ Scores - Adult Group |
-2.5; -0.0; -2.9; 0.7; -2.7; -2.1 | — |
| SECONDARY Change From Baseline in CFQ Scores - Adolescents Group |
1.1; 3.2; -1.9; 1.1; -1.6; -1.1 | — |
| SECONDARY Change From Baseline in CFQ Scores - Parent Questionnaire |
-0.1; 4.9; 0.2; -0.3; 0.0; -0.1 | — |
| SECONDARY Amount of Tiotropium Eliminated in Urine From 0 to 4 Hours at Steady State (Ae0-4,ss) |
114; 245 | — |
| SECONDARY Maximum Measured Concentration at Steady State (Cmax,ss) |
6.49; 9.95 | — |
| SECONDARY Time From Dosing to the Maximum Concentration (Tmax,ss) |
0.0830; 0.0830 | — |
| SECONDARY Clinical Relevant Abnormalities for Vital Signs and Laboratory Evaluation |
0; 0; 1; 1; 1; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00737100). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.