A Crossover Study to Determine the 24-h Lung Function Profile of Indacaterol in Patients With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD) - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00622635

Purpose

This study is being conducted to provide detailed information on the efficacy of indacaterol (in terms of the spirometry assessment forced expiratory volume in 1 second [FEV1]) over the full 24-h time period.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: Indacaterol 300 µg once daily (o.d.) Drug: Placebo to indacaterol o.d. Drug: Salmeterol 50 µg twice daily (b.i.d.)	Phase III

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Indacaterol Salmeterol Salmeterol xinafoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Safety Study
Official Title:	A Phase III, Randomized, Double-Blind, Placebo Controlled, Multicenter, 3-Period, 14-Day Crossover Study to Determine the 24-h Lung Function Profile of Indacaterol (300 µg o.d.) in Patients With Moderate-to-Severe COPD, Using Open-Label Salmeterol (50 µg b.i.d.) as Active Control

Further study details as provided by Novartis:

Primary Outcome Measures:

24-h trough FEV1 on Day 14 of treatment. The 24-h trough FEV1 is defined as the mean of FEV1 measurements at 23 h 10 min and 23 h 45 min post-dose

Secondary Outcome Measures:

FEV1 at each scheduled timepoint on Days 1 and 14
Trough FEV1 on Day 1
Peak FEV1 during 4 h post morning dosing on Day 1
Time to peak FEV1 during 4 h post morning dosing on Day 1
FEV1 standardized area under the curve (AUC) from 5 min to 23 h 45 min post-dose on Day 1 and Day 14

Estimated Enrollment:	54
Study Start Date:	January 2008
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Indacaterol 300 µg once daily (o.d.) Indacaterol 300 µg once daily (o.d.), delivered via single-dose dry-powder inhaler (SDDPI)
2: Placebo Comparator	Drug: Placebo to indacaterol o.d. placebo to indacaterol o.d., delivered via SDDPI
3: Active Comparator	Drug: Salmeterol 50 µg twice daily (b.i.d.) Salmeterol 50 µg twice daily (b.i.d.), delivered via multi-dose dry-powder inhaler (MDDPI) (open label)

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2006) and:
- Smoking history of at least 20 pack-years
- Post-bronchodilator FEV1 <80% and ≥30% of the predicted normal value
- Post-bronchodilator FEV1/FVC (forced vital capacity) <70%

Exclusion Criteria:

Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 2 or during the run-in period
Patients requiring long-term oxygen therapy (>15 h a day) for chronic hypoxemia
Patients who have had a respiratory tract infection within 6 weeks prior to screening
Patients with concomitant pulmonary disease
Patients with a history of asthma
Patients with diabetes Type I or uncontrolled diabetes Type II
Any patient with lung cancer or a history of lung cancer
Any patient with active cancer or a history of cancer with less than 5 years disease-free survival time
Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured at screening or randomization is prolonged
Patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period
Patients unable to successfully use a dry powder inhaler device, or perform spirometry measurements

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622635

Locations

United States, Illinois
Novartis Investigator Site
Normal, Illinois, United States
United States, Kansas
Novartis Investigator Site
Shawnee Mission, Kansas, United States
United States, Louisiana
Novartis Investigator Site
Lafayette, Louisiana, United States
United States, North Carolina
Novartis Investigator Site
Raleigh, North Carolina, United States
Novartis Investigator Site
Charlotte, North Carolina, United States
United States, Ohio
Novartis Investigator site
Cincinnati, Ohio, United States
United States, South Carolina
Novartis Investigator Site
Spartanburg, South Carolina, United States
Belgium
Novartis Investigator Site
Hasselt, Belgium
Novartis Investigator Site
Genk, Belgium
Novartis Investigator Site
Herentals, Belgium
Spain
Novartis Investigator Site
Alicante, Spain
Novartis Investigator site
Alzira, Spain
Novartis Investigator site
Mataro, Spain
Novartis Investigator Site
Madrid, Spain

Sponsors and Collaborators

Novartis

More Information

Responsible Party:	Novartis ( external affairs )
Study ID Numbers:	CQAB149B2340
Study First Received:	February 4, 2008
Last Updated:	August 14, 2008
ClinicalTrials.gov Identifier:	NCT00622635
Health Authority:	United States: Food and Drug Administration; Spain: Spanish Agency of Medicines; Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Novartis:

Chronic Obstructive Pulmonary Disease
COPD
indacaterol
adults

Study placed in the following topic categories:

Lung Diseases, Obstructive
Salmeterol
Respiratory Tract Diseases

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents

Adrenergic Agonists
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009