Study to Assess the Safety and Tolerability of Incremental Doses of QAB149 in Adults With Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD)

COPD Clinical Trial

Official title:

Dose Escalation Study to Assess the Safety and Tolerability of Incremental Doses of QAB149 in Adults With Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00129831
• Other study ID #: CQAB149B2202
• Status: Completed
• Phase: Phase 2
• First received: August 11, 2005
• Last updated: October 24, 2011
• Start date: September 2004
• Est. completion date: September 2005

Study information

• Verified date: October 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety and tolerability of single doses of QAB149 up to 3000 µg delivered via a single-dose, dry powder inhaler in patients with mild to moderate COPD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male and/or female patients with mild to moderate stable COPD, diagnosed according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines; 40-75 years of age

• Prebronchodilator baseline forced expiratory volume in 1 second (FEV1) 30-80% of the Quanjer predicted normal value (Quanjer et al. 1993) and at least 0.75 L with FEV1/forced vital capacity (FVC) < 70% of predicted [GOLD guidelines].

• Previous smokers (>10 pack-years). Ten pack years are defined as: 20 cigarettes a day for 10 years; 10 cigarettes a day for 20 years; or 40 cigarettes a day for 5 years. Current smokers, with >10 pack year history, can be included under certain conditions.

• Vital signs (after 3 minutes resting measured in the supine position) which are within the following ranges:

• oral body temperature between 35.0-37.5 °C;

• systolic blood pressure, 100-170 mm Hg;

• diastolic blood pressure, 50-100 mm Hg;

• pulse rate, 50 - 90 beats per minute (bpm).

• Patients must weigh a minimum of 50 kg to participate in this study.

• Able to provide written informed consent prior to study participation.

• Able to communicate well with the investigator and comply with the requirements of the study.

Exclusion Criteria:

• Pregnant women or nursing mothers.

• Patients with a QTc interval above 0.43 seconds for males and 0.45 seconds for females at the screening visit. If pre-treatment values on Day 1 of the treatment periods exceed 0.45 and 0.47 seconds for males and females respectively the visit may be re-scheduled once.

• Patients with a history of prolonged QTc intervals, or a family history of prolonged QT syndrome.

• Predominant diagnosis of asthma. (Patients must present without evidence of active asthma.)

• Patients who have been hospitalized or had emergency treatment for acute COPD exacerbation in the one month prior to or during screening.

• Patients who have had a respiratory tract infection within one month prior to screening.

• Patients with concomitant pulmonary disease, including a history of cancer

Other exclusion criteria apply.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• QAB149

Locations

Country	Name	City	State
United States	Radiant Research	Boise	Idaho
United States	Radiant Research	Encinitas	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety variables (laboratory tests, ECG, adverse events)
Secondary	Lung function tests
Secondary	Pharmacokinetics