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Comparison of the Effects of Indacaterol and Tiotropium on Inspiratory Capacity

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Indacaterol 150 μg
Tiotropium 18 μg
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, indacaterol, tiotropium

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of moderate (as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2007) chronic obstructive pulmonary disease (COPD) and:

    1. Smoking history of at least 10 pack-years.
    2. Forced expiratory volume in 1 second (FEV1) < 80% and ≥ 50% of the predicted normal value.
    3. Post-bronchodilator FEV1/Force vital capacity (FVC) < 0.7.

Exclusion Criteria:

  • Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid treatment or antibiotics and/or hospitalization in the 6 weeks prior to screening.
  • Patients who have had a respiratory tract infection within 6 weeks prior to screening.
  • Patients with concomitant pulmonary disease.
  • Patients with alpha-1-antitrypsin deficiency.
  • Patients with contraindications for tiotropium treatment.
  • Patients with a history of hypersensitivity to any of the study drugs or to drugs from similar drug classes.

Other protocol-defined inclusion/exclusion criteria applied to the study.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Indacaterol 150 μg-tiotropium 18 μg-placebo

Tiotropium 18 μg-placebo-indacaterol 150 μg

Placebo-indacaterol 150 μg-tiotropium 18 μg

Arm Description

Patients received indacaterol 150 μg once. After a 5-9 days washout period, patients received tiotropium 18 μg once. After a second 5-9 days washout period, patients received placebo (matching indacaterol) once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.

Patients received tiotropium 18 μg once. After a 5-9 days washout period, patients received placebo (matching indacaterol) once. After a second 5-9 days washout period, patients received indacaterol 150 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.

Patients received placebo (matching indacaterol) once. After a 5-9 days washout period, patients received indacaterol 150 μg once. After a second 5-9 days washout period, patients received tiotropium 18 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.

Outcomes

Primary Outcome Measures

Peak Inspiratory Capacity Assessed With Spirometry in the 4 Hours After Treatment
During the 4 hours following inhalation of the study treatment, inspiratory capacity (IC) was measured with spirometry conducted according to internationally accepted standards. IC was measured 3 times each at 30, 60, 120, 180, and 240 minutes post-dose and the highest value was reported in liters.

Secondary Outcome Measures

Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time.
Force Vital Capacity (FVC) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment
FVC was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time.

Full Information

First Posted
October 21, 2009
Last Updated
February 16, 2016
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00999908
Brief Title
Comparison of the Effects of Indacaterol and Tiotropium on Inspiratory Capacity
Official Title
Multicenter, Randomized, Blinded, Placebo-controlled, Crossover, Single-dose Study to Assess the Effect of Indacaterol (150 μg) Versus Tiotropium (18 μg) on Inspiratory Capacity in Moderate Chronic Obstructive Pulmonary Disease (COPD) Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
This study compared the effects of a single dose of indacaterol with that of a single dose of tiotropium on inspiratory capacity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, indacaterol, tiotropium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Indacaterol 150 μg-tiotropium 18 μg-placebo
Arm Type
Experimental
Arm Description
Patients received indacaterol 150 μg once. After a 5-9 days washout period, patients received tiotropium 18 μg once. After a second 5-9 days washout period, patients received placebo (matching indacaterol) once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
Arm Title
Tiotropium 18 μg-placebo-indacaterol 150 μg
Arm Type
Experimental
Arm Description
Patients received tiotropium 18 μg once. After a 5-9 days washout period, patients received placebo (matching indacaterol) once. After a second 5-9 days washout period, patients received indacaterol 150 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
Arm Title
Placebo-indacaterol 150 μg-tiotropium 18 μg
Arm Type
Experimental
Arm Description
Patients received placebo (matching indacaterol) once. After a 5-9 days washout period, patients received indacaterol 150 μg once. After a second 5-9 days washout period, patients received tiotropium 18 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
Intervention Type
Drug
Intervention Name(s)
Indacaterol 150 μg
Intervention Description
Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Intervention Type
Drug
Intervention Name(s)
Tiotropium 18 μg
Intervention Description
Tiotropium was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo (matching indacaterol) was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Primary Outcome Measure Information:
Title
Peak Inspiratory Capacity Assessed With Spirometry in the 4 Hours After Treatment
Description
During the 4 hours following inhalation of the study treatment, inspiratory capacity (IC) was measured with spirometry conducted according to internationally accepted standards. IC was measured 3 times each at 30, 60, 120, 180, and 240 minutes post-dose and the highest value was reported in liters.
Time Frame
4 hour period following inhalation of study treatment
Secondary Outcome Measure Information:
Title
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment
Description
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time.
Time Frame
4 hour period following inhalation of study treatment
Title
Force Vital Capacity (FVC) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment
Description
FVC was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time.
Time Frame
4 hour period following inhalation of study treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of moderate (as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2007) chronic obstructive pulmonary disease (COPD) and: Smoking history of at least 10 pack-years. Forced expiratory volume in 1 second (FEV1) < 80% and ≥ 50% of the predicted normal value. Post-bronchodilator FEV1/Force vital capacity (FVC) < 0.7. Exclusion Criteria: Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid treatment or antibiotics and/or hospitalization in the 6 weeks prior to screening. Patients who have had a respiratory tract infection within 6 weeks prior to screening. Patients with concomitant pulmonary disease. Patients with alpha-1-antitrypsin deficiency. Patients with contraindications for tiotropium treatment. Patients with a history of hypersensitivity to any of the study drugs or to drugs from similar drug classes. Other protocol-defined inclusion/exclusion criteria applied to the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Bergamo
Country
Italy
Facility Name
Novartis Investigative Site
City
Brescia
Country
Italy
Facility Name
Novartis Investigative Site
City
Cava De' Tirreni
Country
Italy
Facility Name
Novartis Investigative Site
City
Genova
Country
Italy
Facility Name
Novartis Investigative Site
City
Milano
Country
Italy
Facility Name
Novartis Investigative Site
City
Orbassano
Country
Italy
Facility Name
Novartis Investigative Site
City
Pavia
Country
Italy
Facility Name
Novartis Investigative Site
City
Reggio Emilia
Country
Italy
Facility Name
Novartis Investigative Site
City
Sesto San Giovanni
Country
Italy
Facility Name
Novartis Investigative Site
City
Treviso
Country
Italy
Facility Name
Novartis Investigative Site
City
Verona
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
22035851
Citation
Rossi A, Centanni S, Cerveri I, Gulotta C, Foresi A, Cazzola M, Brusasco V. Acute effects of indacaterol on lung hyperinflation in moderate COPD: a comparison with tiotropium. Respir Med. 2012 Jan;106(1):84-90. doi: 10.1016/j.rmed.2011.09.006. Epub 2011 Oct 27.
Results Reference
derived

Learn more about this trial

Comparison of the Effects of Indacaterol and Tiotropium on Inspiratory Capacity

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