Effect of Indacaterol on Inspiratory Capacity and Lung Function in Patients With COPD Versus Placebo and Formoterol

COPD Clinical Trial

Official title:

An Exploratory, Double-Blind Comparison of Inspiratory Capacity (IC) and FEV1 in COPD Patients Following Single Dose Administration of Indacaterol and Placebo and Open Label b.i.d. Administration of Formoterol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00422552
• Other study ID #: CQAB149B2211
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 16, 2007
• Last updated: June 21, 2007
• Start date: September 2006

Study information

• Verified date: June 2007
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the change in inspiratory capacity and lung function in patients with chronic obstructive pulmonary disease when treated with indacaterol compared to placebo and formoterol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Male and post-menopausal female adults aged 40-80 years inclusive.

• Patients with a clinical diagnosis of COPD according to the Global Initiative for Chronic Lung Disease (GOLD) Guidelines (2005)

• Smoking history of at least 10 pack years (either smokers or ex-smokers).

• Able to perform reproducible spirometry maneuvers.

• Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.

Exclusion Criteria:

• COPD exacerbations within 6 weeks prior to dosing

• Concomitant lung disease such as asthma, requirement for long term oxygen treatment or history of lung reduction surgery.

• Medical conditions that would interfere with the performance of spirometry or may pose a potential hazard from performing spirometry.

• 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 being in the study, e.g. uncontrolled hypertension, unstable ischemic heart disease.

• Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Respiratory Aspiration

Intervention

Drug:
• Indacaterol (QAB149)

Locations

Country	Name	City	State
United Kingdom	Novartis Investigative site	Horsham

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in IC and percent predicted FEV1 at various timepoints over 24 hours
Secondary	Percent predicted FEV1 time course change over 24 hours
Secondary	Mean maximal change in IC time course change over 24 hours