Phase 3
Completed N=983
Tiotropium / Respimat One-Year Study
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT00168844 ↗
Enrolled (actual)
983
Serious AEs
—
Results posted
Oct 2009
Primary outcomePrimary: Change From Baseline in Trough FEV1 at Week 48, Full Analysis Set - Clinic Spirometry (FAS-PFT) — 0.097; 0.116; -0.046 Litres — p=<0.0001
Summary
To evaluate the long term effects of treatment with two doses of Tiotropium delivered by the Respimat inhaler in patients with COPD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Trough FEV1 at Week 48, Full Analysis Set - Clinic Spirometry (FAS-PFT) |
0.097; 0.116; -0.046 | <0.0001 sig |
| PRIMARY Saint George's Respiratory Questionnaire (SGRQ) Total Score, Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL) |
39.648; 38.675; 42.917 | 0.0011 sig |
| PRIMARY TDI Focal Score, Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI) (Combined Studies) |
1.890; 1.913; 0.837 | <0.0001 sig |
| PRIMARY COPD Exacerbation Rate, Safety Set (SS) (Combined Studies) |
0.93; 1.02; 1.91 | 0.0002 sig |
| SECONDARY Change From Baseline in Heart Rate |
0.3; 1.2; 0.3 | — |
| SECONDARY Change From Baseline in PR Interval |
-0.8; -2.5; -0.5 | — |
| SECONDARY Change From Baseline in QRS Interval |
0.9; 1.7; -1.1 | — |
| SECONDARY Change From Baseline in QT Interval |
-4.6; -3.5; -3.2 | — |
| SECONDARY Change From Baseline in QT Interval (Bazett) |
-0.5; 5.4; 2.5 | — |
| SECONDARY Change From Baseline in QT Interval (Fridericia) |
-2.0; 2.2; 0.5 | — |
| SECONDARY Change From Baseline in Supraventricular Premature Beat (SVPB) Total |
-3.4; 6.8; 20.9 | — |
| SECONDARY Holter (24-hour Period) - SVPB (Supraventricular Premature Beat) Run Events Change From Baseline in Supraventricular Premature Beat (SVPB) Run Events |
0.0; -0.1; -0.1 | — |
| SECONDARY Change From Baseline in SVPB Pairs |
-0.4; -0.2; 2.0 | — |
| SECONDARY Change From Baseline in Ventricular Premature Beat (VPB) Total |
-14.3; 4.6; -24.1 | — |
| SECONDARY Change From Baseline in VPB Run Events |
0.0; 0.0; 0.0 | — |
| SECONDARY Change From Baseline in VPB Pairs |
-0.2; -0.1; -0.9 | — |
| SECONDARY Change From Baseline in Haematocrit, Packed Cell Volume (PCV) |
0; -1; 0 | — |
| SECONDARY Change From Baseline in Haemoglobin |
-1; -2; 1 | — |
| SECONDARY Change From Baseline in Red Blood Cell Count |
0.0; -0.1; 0.0 | — |
| SECONDARY Change From Baseline in White Blood Cell Count |
0.1; 0.0; 0.2 | — |
| SECONDARY Change From Baseline in Platelets |
4; 1; 7 | — |
| SECONDARY Change From Baseline in Neutrophils |
1; 1; 1 | — |
| SECONDARY Change From Baseline in Eosinophils |
0; 0; 0 | — |
| SECONDARY Change From Baseline in Basophils |
0; 0; 0 | — |
| SECONDARY Change From Baseline in Lymphocytes |
-1; -1; 0 | — |
| SECONDARY Change From Baseline in Monocytes |
0; 0; 0 | — |
| SECONDARY Change From Baseline in Neutrophils (Absolute) |
0.2; 0.1; 0.2 | — |
| SECONDARY Change From Baseline in Lymphocytes (Absolute) |
0.0; -0.1; 0.1 | — |
| SECONDARY Change From Baseline in Eosinophils (Absolute) |
0.0; 0.0; 0.0 | — |
| SECONDARY Change From Baseline in Basophils (Absolute) |
0.0; 0.0; 0.0 | — |
| SECONDARY Change From Baseline in Monocytes (Absolute) |
0.0; 0.0; 0.0 | — |
| SECONDARY Change From Baseline in Calcium |
0.0; 0.0; 0.0 | — |
| SECONDARY Change From Baseline in Phosphate |
0.02; 0.00; 0.01 | — |
| SECONDARY Change From Baseline in Aspartate Transaminase (AST)/Glutamic-Oxaloacetic Transaminase (GOT), Serum GOT (SGOT) |
-3; -1; 0 | — |
| SECONDARY Change From Baseline in Alanine Transaminase (ALT)/Glutamic Pyruvic Transaminase (GPT), Serum GPT (SGPT) |
-2; -1; -1 | — |
| SECONDARY Change From Baseline in Alkaline Phosphatase |
-3; -6; -5 | — |
| SECONDARY Change From Baseline in Lactic Dehydrogenase (LDH) |
4; 2; 0 | — |
| SECONDARY Change From Baseline in Glucose |
-0.09; 0.07; 0.17 | — |
| SECONDARY Change From Baseline in Urea |
0.1; 0.0; 0.0 | — |
| SECONDARY Change From Baseline in Blood Urea Nitrogen |
0.1; 0.0; -0.1 | — |
| SECONDARY Change From Baseline in Creatinine |
2.7; 1.0; 1.7 | — |
| SECONDARY Change From Baseline in Bilirubin, Total |
0.0; -0.1; 0.0 | — |
| SECONDARY Change From Baseline in Uric Acid |
13.55; 1.03; 7.83 | — |
| SECONDARY Change From Baseline in Protein, Total |
-1; -1; -1 | — |
| SECONDARY Change From Baseline in Albumin |
1; 1; 1 | — |
| SECONDARY Change From Baseline in Trough FEV1 After 2, 8, 16, 24, 32 and 40 Weeks |
0.118; 0.133; 0.013; 0.124; 0.150; -0.004 | — |
| SECONDARY Change From Baseline in Trough FVC After 2, 8, 16, 24, 32, 40 and 48 Weeks |
0.163; 0.278; 0.025; 0.168; 0.300; 0.009 | <0.0001 sig |
| SECONDARY Change From Baseline in FEV1 AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks |
0.256; 0.258; 0.045; 0.246; 0.274; 0.041 | <0.0001 sig |
| SECONDARY Change From Baseline in FVC AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks |
0.421; 0.492; 0.130; 0.397; 0.538; 0.126 | <0.0001 sig |
| SECONDARY Weekly Mean Morning Pre-dose PEFRs |
255.4; 261.5; 235.4; 259.0; 265.6; 241.8 | <0.0001 sig |
| SECONDARY Weekly Mean Evening PEFRs |
270.6; 279.2; 249.3; 274.5; 282.1; 253.4 | <0.0001 sig |
| SECONDARY Weekly Mean Number of Puffs of Rescue Medication Per Day |
1.9; 1.9; 2.7; 2.0; 2.0; 2.7 | <0.0001 sig |
| SECONDARY Mahler TDI Scores |
0.606; 0.679; 0.255; 0.650; 0.673; 0.291 | — |
| SECONDARY Saint George's Respiratory Questionnaire (SGRQ) Scores |
42.323; 41.798; 47.835; 56.317; 55.180; 58.629 | — |
| SECONDARY COPD Symptoms Scores |
0.67; 0.65; 0.91; 1.35; 1.31; 1.51 | — |
| SECONDARY PGE Scores |
5.18; 5.18; 4.62 | — |
| SECONDARY PGR Score |
3.05; 2.86; 3.52 | — |
Data sourced from ClinicalTrials.gov (NCT00168844). 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.