Indacaterol Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) in Chronic Obstructive Pulmonary Disease (COPD)

NCT00396604 | Completed Phase 2

• 1 other identifier: CQAB149B2212
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed to obtain safety and efficacy data on three dose levels of indacaterol when delivered via an SDDPI in patients with COPD. All patients will receive 1 day of treatment with each of the following: indacaterol 150 µg, once- indacaterol 300 µg, indacaterol 600 µg, placebo, and formoterol. Each treatment day will be followed by a washout-period of 1 week.

Conditions

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

Keywords

indacaterol; long acting beta agonist

Outcome Measures

Primary Outcomes (1)

• Lung function measured 24 hours after having taken medication, by a special test called "forced expiratory volume in 1 second "(FEV1)

Secondary Outcomes (4)

• FEV1 at time points 30 min, 1, 2 and 4hours post-dose

• Percent change in FEV1 at time points 30 min, 1, 2 and 4 hours, 23 hours 10min and 23 hours 45 min post dose

• Forced vital capacity (FVC) at time points 30 min, 1, 2 and 4 hours, 23 hours 10 min and 23 hours 45 min post dose

• Standardized FEV1 area under the curve (AUC) between baseline and 4 hours

Interventions

indacaterol maleate DRUG

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and females aged 40-75 years with COPD and symptoms such as cough, sputum production, and shortness of breath.
• Smoking history of at least 10 pack years
• FEV1 less than 65% of the predicted normal value and at least 0.75 L
• Pre-bronchodilator FEV1/FVC less than 70%

You may not qualify if:

• A history of asthma or COPD diagnosis before the age of 40
• Hospitalization for COPD exacerbation within the previous 6 weeks
• Respiratory tract infection within 6 weeks
• Use of long-term oxygen therapy
• Diabetes type I or uncontrolled diabetes type II
• Clinically relevant laboratory abnormality or clinically significant condition

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis

Vilvoorde, Belgium

Location

Related Publications (1)

• Hosoe M, Woessner R, Matsushima S, Lawrence D, Kramer B. Efficacy, safety and pharmacokinetics of indacaterol in Caucasian and Japanese patients with chronic obstructive pulmonary disease: a comparison of data from two randomized, placebo-controlled studies. Clin Drug Investig. 2011;31(4):247-55. doi: 10.2165/11586520-000000000-00000.

  PMID: 21184620 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis

  Novartis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 6, 2006
• First Posted: November 7, 2006
• Study Start: October 1, 2006
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: October 25, 2011

Record last verified: 2011-10

Locations

BE (1)