Clinical trial NCT00669617: Study to Determine the Onset of Action of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: chronic obstructive pulmonary disease
COPD
indacaterol
adults
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-04-30
Enrollment: 89
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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


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* Concomitant pulmonary disease, pulmonary tuberculosis (unless chest x-ray confirms no longer active) or clinically significant bronchiectasis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

Primary outcomes:
measure: Forced Expiratory Volume in 1 Second (FEV1) at 5 Minutes Post-dose
timeFrame: Five Minutes Post Dose
Secondary outcomes:
Other outcomes:
Locations:
city: Tamarac
country: United States
facility: Novartis Investigative Site
state: Florida
city: Lafayette
country: United States
facility: Novartis Investigator Site
state: Louisiana
city: St Charles
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Shelby
country: United States
facility: Novartis Investigative site
state: North Carolina
city: Beaver
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Antwerpen
country: Belgium
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Borstel
country: Germany
facility: Novartis Investigator Site
city: Dortmund
country: Germany
facility: Novartis Investigative site
city: Hamburg
country: Germany
facility: Novartis Investigative site
city: Hannover
country: Germany
facility: Novartis Investigative site
city: Mainz
country: Germany
facility: Novartis Investigative site
city: Potsdam
country: Germany
facility: Novartis Investigator Site
city: Wiesbaden
country: Germany
facility: Novartis Investigative site
city: Debrecen
country: Hungary
facility: Novartis Investigative site
city: Deszk
country: Hungary
facility: Novartis Investigative site
city: Nyiregyhaza
country: Hungary
facility: Novartis Investigative Site
Study officials:
References: