The Effect of QVA149 on Health Related Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD) (QUANTIFY)

Novartis

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Placebo to QVA149; Drug: QVA149; Drug: Formoterol; Drug: Placebo to formoterol; Drug: Tiotropium; Drug: Placebo to tiotropium

Study type: Interventional

Funder types: Industry

Identifiers

NCT01574651

2011-004870-26 (EudraCT Number)

CQVA149ADE01

Details and patient eligibility

About

This study will assess the efficacy and safety of QVA149 compared to tiotropium plus formoterol in patients with moderate to severe COPD.

Enrollment: 934 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female adults aged ≥ 40 yrs
• Patients with moderate to severe chronic obstructive pulmonary disease (GOLD 2010 guidelines)
• Smoking history of at least 10 pack years
• Post-bronchodilator FEV1 < 80% and ≥30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) <70%

Exclusion criteria

• Pregnant women or nursing mothers or women of child-bearing potential not using adequate contraception
• Patients with a history of long QT syndrome
• Patients with Type I or uncontrolled Type II diabetes
• Patients who have had a COPD exacerbation or respiratory tract infection within 6 weeks prior to screening
• Patients with any history of asthma
• Patients with pulmonary lobectomy, lung volume reduction surgery, or lung transplantation
• Patients with concomitant pulmonary disease
• Patients requiring long term oxygen therapy (>15 h a day)

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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934 participants in 2 patient groups

QVA149 plus placebo to tiotropium and placebo to formoterol

Experimental group

Description:

QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.

Treatment:

Drug: Placebo to formoterol

Drug: QVA149

Drug: Placebo to tiotropium

Tiotropium plus Formoterol and placebo to QVA149

Active Comparator group

Description:

Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.

Treatment:

Drug: Tiotropium

Drug: Formoterol

Drug: Placebo to QVA149