Study to Determine the Onset of Action of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

A Phase III, Randomized, Double-blind, Triple-dummy, Placebo Controlled, Multicenter, 5-period, Single-dose Complete Block Crossover Study to Determine the Onset of Action of Indacaterol (150 and 300 μg) in Patients With Moderate to Severe COPD Using Salbutamol (200 μg) and Salmeterol/Fluticasone (50/500 μg) as Active Controls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00669617
• Other study ID #: CQAB149B2307
• Secondary ID: EUDRACT: 2007-00
• Status: Completed
• Phase: Phase 3
• First received: April 28, 2008
• Last updated: September 7, 2011
• Start date: April 2008
• Est. completion date: August 2008

Study information

• Verified date: September 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the onset of action of indacaterol (150 and 300 µg) as compared to placebo, salbutamol 200 µg and salmeterol/fluticasone 50/500 µg

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Male and female adults aged =40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure

• Patients with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (moderate-to-severe as classified by the GOLD Guidelines, 2006) and:

• Smoking history of at least 20 pack years

• Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) <80% and =30% of the predicted normal value.

• Post-bronchodilator FEV1/Forced Vital Capacity (FVC) < 70%, where FVC is forced vital capacity ('Post-' refers to 15-30 minutes after inhalation of 400 µg of salbutamol at Visit 2)

Exclusion Criteria:

• Pregnant / nursing women or women of child-bearing potential

• Long term oxygen therapy (more than 15 hours per day) on a daily basis for chronic hypoxemia

• Patients hospitalized for COPD exacerbation in 6 weeks prior to Visit 2 and up to Visit 3

• Respiratory tract infection within 6 weeks prior to Visit 2 and up to Visit 3

• Concomitant pulmonary disease, pulmonary tuberculosis (unless chest x-ray confirms no longer active) or clinically significant bronchiectasis

• Any history of asthma, including: blood eosinophil count >400/mm3; onset of asthma symptoms prior to age 40 years

• History of long QT syndrome or whose QTc (Bazett's) measured at Visit 2 or Visit 3 is prolonged (>450ms for males or >470ms for females)

• Clinically relevant lab abnormalities / conditions such as (but not limited to) unstable ischemic heart disease, arrhythmia (excluding stable AF), uncontrolled hypertension, uncontrolled hypo- and hyperthyroidism, hypokalemia, hyperadrenergic state or any condition which in the investigator's opinion might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study

• Uncontrolled Type I / Type II Diabetes or blood glucose outside normal or HbA1c >8.0% of total hemoglobin measured at Visit 2

• Any patient with lung cancer or any active cancer or a history of cancer with less than 5 years disease-free survival time

• History of hypersensitivity to any of the study drugs

• Irregular day/night, waking/sleeping cycles e.g. shift workers

• Live attenuated vaccinations within 30 days prior to Visit 2

• Investigational drug within 30 days prior to Visit 2

• Known history of non-compliance or not able to use devices or perform spirometry

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Indacaterol
Indacaterol 150 and 300 µg, delivered via single-dose dry-powder inhaler (SDDPI)
• Salmeterol/fluticasone (50/500 µg)
Salmeterol/fluticasone 50/500 µg fixed-dose combination delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).
• Salbutamol (200 µg)
Salbutamol 200 µg delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).
• Placebo to Indacaterol
Placebo to indacaterol delivered via SDDPI
• Placebo to Salmeterol/fluticasone
Placebo to salmeterol/fluticasone delivered via MDDPI
• Placebo to salbutamol
Placebo to salbutamol delivered via MDDPI

Locations

Country	Name	City	State
Belgium	Novartis Investigative Site	Antwerpen
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigator Site	Borstel
Germany	Novartis Investigative site	Dortmund
Germany	Novartis Investigative site	Hamburg
Germany	Novartis Investigative site	Hannover
Germany	Novartis Investigative site	Mainz
Germany	Novartis Investigator Site	Potsdam
Germany	Novartis Investigative site	Wiesbaden
Hungary	Novartis Investigative site	Debrecen
Hungary	Novartis Investigative site	Deszk
Hungary	Novartis Investigative Site	Nyiregyhaza
United States	Novartis Investigative Site	Beaver	Pennsylvania
United States	Novartis Investigator Site	Lafayette	Louisiana
United States	Novartis Investigative site	Shelby	North Carolina
United States	Novartis Investigative Site	St Charles	Missouri
United States	Novartis Investigative Site	Tamarac	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced Expiratory Volume in 1 Second (FEV1) at 5 Minutes Post-dose	FEV1 was measured at 5 minutes after dosing with spirometry conducted according to internationally accepted standards. The time of dosing was defined as the time corresponding to the use of the first inhaler device. The primary variable was analyzed using a mixed model containing the period baseline FEV1 as covariate. The period baseline FEV1 was the average of the FEV1 value measured in the clinic at 50 and 15 min prior to the study drug administration in that period.	Five Minutes Post Dose	No