Phase 3
Completed N=163
Long Term Safety and Tolerability of NVA237 Versus Tiotropium in Japanese Patients
Source: ClinicalTrials.gov NCT01119937 ↗Enrolled (actual)
163
Serious AEs
13.5%
Results posted
Jan 2013
Primary outcomePrimary: Number of Participants With Adverse Events, Serious Adverse Events or Death — 102; 33; 16; 6 participants
Summary
This is a 52-week, multi-center, randomized, open label, parallel group study to assess the long term safety and tolerability of once-daily NVA237, using tiotropium as an active control, in Japanese patients with moderate to severe chronic obstructive pulmonary disease (COPD) .
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events, Serious Adverse Events or Death |
102; 33; 16; 6; 0; 0 | — |
| SECONDARY Change in Pre-dose FEV1 From Baseline |
0.101; 0.173; 0.094; 0.144; 0.084; 0.112 | — |
| SECONDARY Change in Pre-dose FVC From Baseline |
0.221; 0.220; 0.218; 0.179; 0.208; 0.146 | — |
| SECONDARY Time From Randomization Until the Start of the First Moderate or Severe COPD Exacerbation |
362; 359 | — |
| SECONDARY Number of Patients With Moderate or Severe COPD Exacerbations |
99; 31; 17; 5; 5; 3 | — |
| SECONDARY Change in St. George Respiratory Questionnaire From Baseline |
-2.57; -2.31; -1.77; -3.24; -2.54; -0.93 | — |
| SECONDARY Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Over the Whole Treatment Period |
-0.16; -0.27 | — |
| SECONDARY Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period |
3; 2; 0; 0; 3; 4 | — |
| SECONDARY Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint Over the Whole Treatment Period |
0; 1; 0; 0; 0; 1 | — |
| SECONDARY Number of Patients With Notable Change From Baseline in Fridericia's QTc Values at Any Timepoint Over the Whole Treatment Period |
6; 1; 2; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with moderate to severe stable COPD (Stage II or Stage III) according to the Gold Guideline 2008.
- Current or ex-smokers who have a smoking history of at least 10 pack years.
- Patients with a post-bronchodilator FEV1 ≥30% and < 80% of the predicted normal, and postbronchodilator FEV1/FVC < 0.7 at Visit 2 (day -7)
Exclusion Criteria
- Pregnant women or nursing mothers or women of child-bearing potential not using an acceptable method of contraception
- Patients requiring long term oxygen therapy
- Patients who have had a lower respiratory tract infection within 6 weeks prior to Visit 1
- Patients with concomitant pulmonary disease
- Patients with a history of asthma
- Any patient with lung cancer or a history of lung cancer
- Patients with a history of certain cardiovascular comorbid conditions
- Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
- Patients in the active phase of a supervised pulmonary rehabilitation program
- Patients contraindicated for tiotropium or ipratropium treatment or who have shown an untoward reaction to inhaled anticholinergic agents
- Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01119937). 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.