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

PHASE3CompletedINTERVENTIONAL
Enrollment

934

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

April 30, 2013

Study Completion Date

April 30, 2013

Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Interventions
DRUG

QVA149

QVA149 110/50µg, once daily (q.d.) is administered via a single-dose dry powder inhaler

DRUG

Placebo to tiotropium

Placebo to tiotropium capsules daily (q.d.) for inhalation, delivered via proprietary inhaler (Handihaler®). Placebo tiotropium inhalation capsules were matched in size and color to tiotropium 18 μg q.d. inhalation capsules

DRUG

Placebo to formoterol

Placebo to formoterol capsules twice daily (b.i.d) delivered via Aerolizer® device. Placebo formoterol inhalation capsules were equally matched in size, shape and color to formoterol 12 μg b.i.d. inhalation capsules.

DRUG

Tiotropium

Tiotropium 18µg, once daily is administered via the manufacturer's proprietary inhalation device.

DRUG

Formoterol

Formoterol 12µg, twice daily is administered via the manufacturer's proprietary inhalation device.

DRUG

Placebo to QVA149

Placebo to QVA149 is administered via a single-dose dry powder inhaler. Placebo QVA149 inhalation capsules were equally matched in size, shape and color to QVA149 110/50 μg q.d. inhalation capsules

Trial Locations (144)

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Novartis Investigative Site, Berlin

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Novartis Investigative Site, Berlin

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Novartis Investigative Site, Berlin

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Novartis Investigative Site, Berlin

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Novartis Investigative Site, Potsdam

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Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY