Phase 3 Completed N=339 Randomized Quadruple-blind Treatment

A Study to Assess the Long-term Safety of QVA149

Chronic Obstructive Pulmonary Disease

Source: ClinicalTrials.gov NCT01120717 ↗

Enrolled (actual)

339

Serious AEs

14.5%

Results posted

Jan 2013

Primary outcomePrimary: Number of Participants With Adverse Events, Serious Adverse Events or Death — 130; 64; 37; 12 participants

Summary

The study is designed to provide long-term safety data for QVA149 in 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	130; 64; 37; 12; 4; 1	—
SECONDARY Pre-dose FEV1	1.607; 1.418	—
SECONDARY Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period	9; 1; 0; 0; 11; 3	—
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; 0	—
SECONDARY Number of Patients With Notable Change From Baseline in Fridericia's QTc Values at Any Timepoint Over the Whole Treatment Period	7; 5; 0; 1	—

Eligibility Criteria

Inclusion Criteria

Male or female adults aged ≥40 yrs
Smoking history of at least 10 pack years
Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008)
Post-bronchodilator FEV1 < 80% and ≥ 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) <70%

Exclusion Criteria

Patients who have had a respiratory tract infection within 4 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 co-morbid 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 inhaled anticholinergic agents and β2 agonists
Other protocol-defined inclusion/exclusion criteria may apply

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01120717). 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.