Safety and Tolerability QAT370 Compared to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease

Novartis

Status and phase: Completed; Phase 1

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Placebo; Drug: QAT370; Drug: Tiotropium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00532350

CQAT370A2103

Details and patient eligibility

About

This study will assess the safety and tolerability of QAT370 compared to tiotropium in patients with COPD.

Enrollment: 22 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients between 40 and 80 years of age with controlled COPD.
• Women must be surgically sterilized or postmenopausal. Additional birth control and post-menopausal information will be available at time of enrollment.
• Body mass index (BMI) must be within the range of 18 to 32 kg/m2

Exclusion criteria

• Participation in any interventional clinical investigation with 4 weeks of study start
• Blood loss or donation of 400 mL or more within 2 months of study start Significant illness (other than respiratory) within 2 weeks of study start
• Past medical personal or close family history of clinically significant ECG abnormalities
• Any medical condition that may interfere with exercise testing or that may make spirometry unsafe
• A known hypersensitivity to the drug.
• History of immunocompromise, including a positive HIV test result.
• History of drug or alcohol abuse within 12 months of study start
• Any condition that may compromise patient safety

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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22 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

QAT370

Treatment:

Drug: QAT370

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

3

Active Comparator group

Description:

Tiotropium

Treatment:

Drug: Tiotropium