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Dose-Ranging Study in Patients With Chronic Obstructive Pulmonary Disease (COPD)

MULTICENTER STUDY RANDOMIZED, DOUBLE-BLIND, CONTROLLED WITH PLACEBO, OF PARALLEL GROUPS, WITH MULTIPLE DOSE (7DAYS) AND DOSE RANGE TO EVALUATE THE EFFICACY AND SAFETY OF 4 DOSES OF QAB149 (50, 100, 200 AND 400 UG) ADMINISTERED THROUGH INHALER OF DRY POWDER MULTIDOSIS AND 1 DOSAGE OF QAB149 (400UG) ADMINISTERED THROUGH DRY POWDER INHALER MONODOSIS IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-028-04
Enrollment
Unknown
Registered
2004-07-08
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

QAB149 50 ug Type of group
QAB149 in the following doses: 50 ug administered via MDDPI. Group name:Placebo via both MDDPI and SDDPI. Type of group
Placebo is administered in MDDPI and SDDPI.

Sponsors

NOVARTIS BIOSCIENSES PERU S.A.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosis of COPD Age 40-75 years Smoking history

Exclusion criteria

Exclusion criteria: Other serious disease Allergy to QAB149 Respiratory tract infection

Design outcomes

Primary

MeasureTime frame
Outcome name:Pulmonary function Measure:Pulmonary function is measured between 22 and 24 hours after dosing on day 1. Timepoints:22 and 24 hours—

Secondary

MeasureTime frame
Outcome name:Pulmonary function Measure:Pulmonary function measured on days 1 and 7 at different intervals after dosing Timepoints:days 1 and 7—

Outcome results

None listed

Source: REPEC (via WHO ICTRP)