An Exploratory Study, to Assess the Effect of Repeat-dose Inhaled Indacaterol Maleate (300 μg) on Dynamic and Static Lung Hyperinflation, Subjective Breathlessness and Health Status in Patients With Chronic Obstructive Pulmonary Disease(COPD)

NCT ID: NCT00636961

Last Updated: 2011-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2008-08-31

Brief Summary

This study evaluated the effect of QAB149 on dynamic and static hyperinflation, breathlessness, and health status in COPD patients

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Sequence 1: Indacaterol 300μg followed by Placebo

In period I, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study.

Group Type: EXPERIMENTAL

Indacaterol 300μg

Intervention Type: DRUG

300μg indacaterol maleate inhalation powder in hard gelatin capsules administered via Concept1 inhalation device

Placebo

Intervention Type: DRUG

Matching placebo devices and hard gelatin capsules

Sequence 2 : Placebo followed by Indacaterol 300μg

In period I, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study.

Group Type: EXPERIMENTAL

Indacaterol 300μg

Intervention Type: DRUG

300μg indacaterol maleate inhalation powder in hard gelatin capsules administered via Concept1 inhalation device

Placebo

Intervention Type: DRUG

Matching placebo devices and hard gelatin capsules

Interventions

Indacaterol 300μg

300μg indacaterol maleate inhalation powder in hard gelatin capsules administered via Concept1 inhalation device

Intervention Type: DRUG

Placebo

Matching placebo devices and hard gelatin capsules

Intervention Type: DRUG

Other Intervention Names

Arcapta

Eligibility Criteria

Inclusion Criteria

• Male and female subjects,
• 40 to 80 years of age,
• with a documented diagnosis of mild, moderate or severe chronic obstructive pulmonary disease (COPD) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria and >20-pack year history of smoking, a post-bronchodilator 40% ≤ FEV1 ≤ 80% of predicted normal and post-bronchodilator FEV1/FVC < 70% who have signed an informed consent form (ICF) prior to the initiation of any study-related procedure (Post bronchodilator refers to 30 minutes after the inhalation of 400 µg of salbutamol)
• Subjects who demonstrate a plethysmographic functional residual capacity >120% predicted normal

Exclusion Criteria

• No COPD exacerbations within 6 weeks prior to dosing,
• no concomitant lung disease such as asthma,
• no requirement for long term oxygen treatment or history of lung reduction surgery.
• No medical conditions that would interfere with the performance of spirometry or clinical exercise testing.
• Any other medical condition that in the opinion of the investigator may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from participating in the study e.g. uncontrolled hypertension or unstable ischemic heart disease

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Novartis

Principal Investigators

Novartis

Role: PRINCIPAL_INVESTIGATOR

Novartis investigator site

Locations

Novartis Investigator Site

Berlin, , Germany

Novartis Investigator Site

Mönchengladbach, , Germany

Novartis Investigator Site

Wiesbaden, , Germany

Countries

Germany

Other Identifiers

CQAB149B2318

Identifier Type: -

Identifier Source: org_study_id