Efficacy and Safety of Single Doses of Indacaterol Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) Compared to Placebo in Patients With Persistent Asthma

NCT00403637 | Completed Phase 2

• 1 other identifier: CQAB149A2228
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 5

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 persistent asthma. All patients will receive 1 day of treatment with each of the following: indacaterol 150 µg, indacaterol 300 µg, indacaterol 600 µg, placebo, and formoterol. Each treatment day will be followed by a washout-period of 1 week

Conditions

Asthma

Keywords

Asthma, indacaterol, long acting β2-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 (3)

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

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

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

Interventions

indacaterol maleate DRUG

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females 12 - 75 years of age with a diagnosis of persistent asthma
• Daily treatment with a bronchodilator and daily dose of at least 100 µg beclomethasone dipropionate or equivalent
• FEV1 at Visit 1 at least 50% of the predicted normal value
• FEV1 reversibility at least 15%

You may not qualify if:

• Use of tobacco products within 6 months prior to Visit 1 or a smoking history of more than 10 pack years
• Chronic Obstructive Pulmonary Disease (COPD)
• Seasonal allergy where asthma is likely to deteriorate during the period of the study
• Emergency room treatment for an acute asthma attack within the previous 6 weeks or hospitalized within the previous 6 months

Sponsors & Collaborators

• Novartis: lead

Study Sites (5)

Colorado Allergy and Asthma Centres, P.C.

Denver, Colorado, 80230, United States

Location

Northeast Medical Research Associates, Inc.

North Dartmouth, Massachusetts, 02747, United States

Location

Clinical Research Institute

Minneapolis, Minnesota, 55402, United States

Location

The Clinical Research Center

St Louis, Missouri, 63141, United States

Location

North Carolina Clinical Research

Raleigh, North Carolina, 27606, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Novartis

  Novartis

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 6, 2006
• First Posted: November 27, 2006
• Study Start: November 1, 2006
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: November 18, 2016

Record last verified: 2016-11

Locations

US (5)