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

NCT ID: NCT00669617

Last Updated: 2011-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2008-08-31

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

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Ind 150μg, Salm/flut, Ind 300μg, Placebo, Salbut

Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Indacaterol 150 μg (Ind 150μg), Salmeterol/fluticasone 50/500 μg (Salm/flut), Indacaterol 300 μg (Ind 300μg), Placebo, Salbutamol 200 μg (Salbut). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Group Type: EXPERIMENTAL

Indacaterol

Intervention Type: DRUG

Indacaterol 150 and 300 μg, delivered via single-dose dry-powder inhaler (SDDPI)

Salmeterol/fluticasone (50/500 μg)

Intervention Type: DRUG

Salmeterol/fluticasone 50/500 μg fixed-dose combination delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).

Salbutamol (200 µg)

Intervention Type: DRUG

Salbutamol 200 μg delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).

Placebo to Indacaterol

Intervention Type: DRUG

Placebo to indacaterol delivered via SDDPI

Placebo to Salmeterol/fluticasone

Intervention Type: DRUG

Placebo to salmeterol/fluticasone delivered via MDDPI

Placebo to salbutamol

Intervention Type: DRUG

Placebo to salbutamol delivered via MDDPI

Ind 300μg, Ind 150μg, Salbut, Salm/flut, Placebo

Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Indacaterol 300 μg (Ind 300μg), Indacaterol 150 μg (Ind 150μg), Salbutamol 200 μg (Salbut), Salmeterol/fluticasone 50/500 μg (Salm/flut), Placebo. At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Group Type: EXPERIMENTAL

Indacaterol

Intervention Type: DRUG

Indacaterol 150 and 300 μg, delivered via single-dose dry-powder inhaler (SDDPI)

Salmeterol/fluticasone (50/500 μg)

Intervention Type: DRUG

Salmeterol/fluticasone 50/500 μg fixed-dose combination delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).

Salbutamol (200 µg)

Intervention Type: DRUG

Salbutamol 200 μg delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).

Placebo to Indacaterol

Intervention Type: DRUG

Placebo to indacaterol delivered via SDDPI

Placebo to Salmeterol/fluticasone

Intervention Type: DRUG

Placebo to salmeterol/fluticasone delivered via MDDPI

Placebo to salbutamol

Intervention Type: DRUG

Placebo to salbutamol delivered via MDDPI

Salm/flut, Placebo, Ind 150μg, Salbut, Ind 300μg

Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Salmeterol/fluticasone 50/500 μg (Salm/flut), Placebo, Indacaterol 150 μg (Ind 150μg), Salbutamol 200 μg (Salbut), Indacaterol 300 μg (Ind 300μg). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Group Type: EXPERIMENTAL

Indacaterol

Intervention Type: DRUG

Indacaterol 150 and 300 μg, delivered via single-dose dry-powder inhaler (SDDPI)

Salmeterol/fluticasone (50/500 μg)

Intervention Type: DRUG

Salmeterol/fluticasone 50/500 μg fixed-dose combination delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).

Salbutamol (200 µg)

Intervention Type: DRUG

Salbutamol 200 μg delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).

Placebo to Indacaterol

Intervention Type: DRUG

Placebo to indacaterol delivered via SDDPI

Placebo to Salmeterol/fluticasone

Intervention Type: DRUG

Placebo to salmeterol/fluticasone delivered via MDDPI

Placebo to salbutamol

Intervention Type: DRUG

Placebo to salbutamol delivered via MDDPI

Salbut, Ind 300μg, Placebo, Ind 150μg, Salm/flut

Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Salbutamol 200 μg (Salbut), Indacaterol 300 μg (Ind 300μg), Placebo, Indacaterol 150 μg (Ind 150μg), Salmeterol/fluticasone 50/500 μg (Salm/flut). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Group Type: EXPERIMENTAL

Indacaterol

Intervention Type: DRUG

Indacaterol 150 and 300 μg, delivered via single-dose dry-powder inhaler (SDDPI)

Salmeterol/fluticasone (50/500 μg)

Intervention Type: DRUG

Salmeterol/fluticasone 50/500 μg fixed-dose combination delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).

Salbutamol (200 µg)

Intervention Type: DRUG

Salbutamol 200 μg delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).

Placebo to Indacaterol

Intervention Type: DRUG

Placebo to indacaterol delivered via SDDPI

Placebo to Salmeterol/fluticasone

Intervention Type: DRUG

Placebo to salmeterol/fluticasone delivered via MDDPI

Placebo to salbutamol

Intervention Type: DRUG

Placebo to salbutamol delivered via MDDPI

Placebo, Salbut, Salm/flut , Ind 300μg, Ind 150μg

Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Placebo, Salbutamol 200 μg (Salbut), Salmeterol/fluticasone 50/500 μg (Salm/flut), Indacaterol 300 μg (Ind 300μg), Indacaterol 150 μg (Ind 150μg). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Group Type: EXPERIMENTAL

Indacaterol

Intervention Type: DRUG

Indacaterol 150 and 300 μg, delivered via single-dose dry-powder inhaler (SDDPI)

Salmeterol/fluticasone (50/500 μg)

Intervention Type: DRUG

Salmeterol/fluticasone 50/500 μg fixed-dose combination delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).

Salbutamol (200 µg)

Intervention Type: DRUG

Salbutamol 200 μg delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).

Placebo to Indacaterol

Intervention Type: DRUG

Placebo to indacaterol delivered via SDDPI

Placebo to Salmeterol/fluticasone

Intervention Type: DRUG

Placebo to salmeterol/fluticasone delivered via MDDPI

Placebo to salbutamol

Intervention Type: DRUG

Placebo to salbutamol delivered via MDDPI

Interventions

Indacaterol

Indacaterol 150 and 300 μg, delivered via single-dose dry-powder inhaler (SDDPI)

Intervention Type: DRUG

Salmeterol/fluticasone (50/500 μg)

Salmeterol/fluticasone 50/500 μg fixed-dose combination delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).

Intervention Type: DRUG

Salbutamol (200 µg)

Salbutamol 200 μg delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).

Intervention Type: DRUG

Placebo to Indacaterol

Placebo to indacaterol delivered via SDDPI

Intervention Type: DRUG

Placebo to Salmeterol/fluticasone

Placebo to salmeterol/fluticasone delivered via MDDPI

Intervention Type: DRUG

Placebo to salbutamol

Placebo to salbutamol delivered via MDDPI

Intervention Type: DRUG

Other Intervention Names

Arcapta; Neohaler

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Novartis

Locations

Novartis Investigative Site

Tamarac, Florida, United States

Novartis Investigator Site

Lafayette, Louisiana, United States

Novartis Investigative Site

Saint Charles, Missouri, United States

Novartis Investigative site

Shelby, North Carolina, United States

Novartis Investigative Site

Beaver, Pennsylvania, United States

Novartis Investigative Site

Antwerp, , Belgium

Novartis Investigative Site

Berlin, , Germany

Novartis Investigator Site

Borstel, , Germany

Novartis Investigative site

Dortmund, , Germany

Novartis Investigative site

Hamburg, , Germany

Novartis Investigative site

Hanover, , Germany

Novartis Investigative site

Mainz, , Germany

Novartis Investigator Site

Potsdam, , Germany

Novartis Investigative site

Wiesbaden, , Germany

Novartis Investigative site

Debrecen, , Hungary

Novartis Investigative site

Deszk, , Hungary

Novartis Investigative Site

Nyíregyháza, , Hungary

Countries

United States; Belgium; Germany; Hungary

Other Identifiers

EUDRACT: 2007-006189-14

Identifier Type: -

Identifier Source: secondary_id

CQAB149B2307

Identifier Type: -

Identifier Source: org_study_id