Phase 3 Completed N=1,007 Randomized Double-blind Treatment

Tiotropium / Respimat One-Year Study

Pulmonary Disease, Chronic Obstructive

Source: ClinicalTrials.gov NCT00168831 ↗

Enrolled (actual)

1,007

Serious AEs

—

Results posted

Oct 2009

Primary outcomePrimary: Change From Baseline in Trough FEV1 After 48 Weeks — 0.077; 0.105; -0.036 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 After 48 Weeks	0.077; 0.105; -0.036	<0.0001 sig
PRIMARY Saint George's Respiratory Questionnaire (SGRQ) Total Score, Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)	39.771; 40.038; 43.484	0.0004 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 Change From Baseline in 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 Ventricular Premature Beat (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; 0; 0	—
SECONDARY Change From Baseline in Haemoglobin	0; -1; -1	—
SECONDARY Change From Baseline in Red Blood Cell Count	0.0; 0.0; 0.0	—
SECONDARY Change From Baseline in White Blood Cell Count	0.2; 0.3; 0.2	—
SECONDARY Change From Baseline in Platelets	5; 3; 0	—
SECONDARY Change From Baseline in Neutrophils	1; 1; 0	—
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; 0.3; 0.2	—
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 Lymphocytes (Absolute)	-0.1; 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	0.01; 0.00; 0.02	—
SECONDARY Change From Baseline in Aspartate Transaminase/Glutamic-oxaloacetic Transaminase (AST/GOT), Serum Glutamic-oxaloacetic Transaminase (SGOT)	-1; -1; -2	—
SECONDARY Change From Baseline in Alanine Transaminase/Glutamic Pyruvate Transaminase (ALT/GPT), Serum Glutamate Pyruvate Transaminase (SGPT)	-1; -1; -1	—
SECONDARY Change From Baseline in Alkaline Phosphatase	-4; -5; -3	—
SECONDARY Change From Baseline in Lactic Dehyrogenase (LDH)	1; 3; 5	—
SECONDARY Change From Baseline in Glucose	0.02; 0.26; 0.10	—
SECONDARY Change From Baseline in Urea	-0.2; 0.0; 0.1	—
SECONDARY Change From Baseline in Blood Urea Nitrogen	-0.3; 0.0; 0.2	—
SECONDARY Change From Baseline in Creatinine	2.2; 1.5; 2.1	—
SECONDARY Change From Baseline in Bilirubin, Total	-0.2; 0.4; -0.1	—
SECONDARY Change From Baseline in Uric Acid	16.41; 9.39; 6.52	—
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	0.111; 0.114; -0.003; 0.099; 0.133; -0.012	—
SECONDARY Change From Baseline in Trough FVC After 2, 8, 16, 24, 32, 40 and 48 Weeks	0.257; 0.264; 0.009; 0.207; 0.266; -0.007	<0.0001 sig
SECONDARY Change From Baseline in FEV1 AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks	0.246; 0.257; 0.044; 0.234; 0.258; 0.037	<0.0001 sig
SECONDARY Change From Baseline in FVC AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks	0.513; 0.522; 0.140; 0.463; 0.521; 0.117	<0.0001 sig
SECONDARY Weekly Mean Morning Pre-dose PEFRs	245.7; 245.4; 226.9; 252.4; 253.9; 229.4	<0.0001 sig
SECONDARY Weekly Mean Morning Evening PEFRs	262.7; 265.0; 237.5; 267.9; 273.5; 240.6	<0.0001 sig
SECONDARY Weekly Mean Number of Puffs of Rescue Medication Per Day	2.0; 2.0; 2.8; 2.3; 2.0; 3.0	0.0169 sig
SECONDARY Mahler TDI Scores	0.630; 0.577; 0.318; 0.654; 0.621; 0.275	—
SECONDARY Saint George's Respiratory Questionnaire (SGRQ) Scores	40.680; 42.108; 48.244; 58.529; 57.045; 60.921	—
SECONDARY COPD Symptoms Scores	0.66; 0.72; 0.85; 1.42; 1.41; 1.61	—
SECONDARY PGE Scores	4.90; 4.84; 4.44	—
SECONDARY PGR Scores	2.88; 2.94; 3.42	—

Eligibility Criteria

Criteria

Patients with stable moderate to severe COPD and a smoking history of at least 10 pack years were eligible for inclusion in the study. Patients with significant diseases other than COPD were excluded as were patients with a recent history of myocardial infarction, history of malignancy, unstable or life-threatening cardiac arrhythmia, narrow-angle glaucoma, asthma or other allergic conditions. Patients treated with cromolyn, nedocromil, oral beta-adrenergics or unstable doses of oral corticosteroids were ineligible for inclusion in the study as were patients who had received previous treatment with tiotropium.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00168831). 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.