Phase 3
Completed N=160
Long Term Safety and Tolerability of QVA149 Versus Tiotropium in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
Source: ClinicalTrials.gov NCT01285492 ↗Enrolled (actual)
160
Serious AEs
13.3%
Results posted
Nov 2013
Primary outcomePrimary: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) or Death — 101; 28; 19; 2 Participants
Summary
This is a 52-week treatment, multi-center, randomized, open label, parallel group study to assess the long term safety and tolerability of once-daily QVA149 (indacaterol and NVA237 ([glycopyrronium bromide]) 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 (AEs), Serious Adverse Events (SAEs) or Death |
101; 28; 19; 2; 1; 0 | — |
| SECONDARY Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period |
3; 0; 0; 0; 6; 0 | — |
| SECONDARY Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Time-point Over the Treatment Period |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Time-point Over the Whole Treatment Period |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Patients With Newly Occurring or Worsening Clinically Notable Fridericia's QTc Values at Any Time-point Over the Whole Treatment Period |
6; 0; 0; 0; 12; 3 | — |
| SECONDARY Change in Pre-dose Forced Expiratory Volume in One Second (FEV1) From Baseline |
0.206; 0.093; 0.202; 0.083; 0.209; 0.139 | — |
| SECONDARY Change in Pre-dose Forced Vital Capacity (FVC) From Baseline |
0.314; 0.213; 0.310; 0.173; 0.335; 0.279 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with moderate to severe stable COPD (Stage II or Stage III) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines 2008.
- Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten pack years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.)
- Patients with post-bronchodilator forced expiratory volume in one second (FEV1) ≥30% and < 80% of the predicted normal, and post-bronchodilator FEV1/forced vital capacity (FVC) < 0.7 at Visit 2.
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 4 weeks prior to Visit 1
- Patients with concomitant pulmonary disease
- Patients with a history of asthma
- Any patient with history of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years
- 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 treatment with, or having a history of reactions/ hypersensitivity to anticholinergic agents, long and short acting beta-2 agonists, sympathomimetic amines
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01285492). 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.