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Confirmatory Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Indacaterol 300 µg
Salmeterol 50 µg
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 (COPD) focused on measuring COPD, Chronic Obstructive Pulmonary Disease, Indacaterol, long acting β2-agonist

Eligibility Criteria

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

Inclusion Criteria:

1. Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines) 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:

  1. Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period
  2. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1
  3. Patients with concomitant pulmonary disease
  4. Patients with a history of asthma
  5. Patients with diabetes Type I or uncontrolled diabetes Type II
  6. Any patient with lung cancer or a history of lung cancer
  7. Patients with a history of certain cardiovascular comorbid conditions
  8. Patients who have been exposed to indacaterol previously. (Except for any patient who enrolled in Study CQAB149B1302)

Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Indacaterol 300 µg

Salmeterol 50 µg

Arm Description

Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.

Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.

Outcomes

Primary Outcome Measures

The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment
The number of participants with newly occurring or worsening clinically notable vital sign: Pulse Rate in beats per minute (bpm) at anytime post baseline (BL) by treatment. Low Pulse Rate was defined as a pulse rate <40 bpm or <= to 50 bpm and a decrease from baseline >= to 15 bpm. High Pulse Rate was defined as a pulse rate >130 bpm or >= to 120 bpm and an increase from baseline >= to 15 bpm.
The Number of Participants With a Clinically Notable Systolic Blood Pressure During 52 Weeks of Treatment
The number of participants with newly occurring or worsening clinically notable vital sign: Systolic Blood Pressure (mmHg) at anytime post baseline (BL) by treatment. A Low Systolic Blood Pressure was defined as a systolic blood pressure measurement: <75 mmHg or <= to 90 mmHg and a decrease from baseline >= to 20 mmHg. A High Systolic Blood Pressure was defined as a systolic blood pressure measurement: >200 mmHg or >= to 180 mmHg and an increase from baseline >= to 20 mmHg.
The Number of Participants With a Clinically Notable Diastolic Blood Pressure During 52 Weeks of Treatment
The number of participants with newly occurring or worsening clinically notable vital sign: Diastolic blood pressure (mmHg) at anytime post baseline (BL) by treatment. A Low Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: <40 mmHg or <= to 50 mmHg and a decrease from baseline >= to 15 mmHg. A High Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: >115 mmHg or >= to 105 mmHg and an increase from baseline >= to 15 mmHg.
The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment
The number of participants with newly occurring or worsening clinically notable QTc Interval value at anytime post baseline. The QTc interval is calculated using Fridericia's formula: QTc= QT/cube root RR. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves in milliseconds (ms). Notable QTc interval >450 ms for males and >470 ms for females. The maximum QTc increase from baseline at any time during the study was also tabulated with absolute and relative frequencies for categories 30- 60 ms and >60 ms.
Serum Potassium (mmol/L) at Weeks 4, 8, 12, 24, 36, 44, and 52
The least squares mean of the serum potassium in mmol/L at weeks 4, 8, 12, 24, 36, 44 and 52. Mixed model used baseline serum potassium as a covariate.
Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 4, 8, 12, 24, 36, 44, and 52
The least squares mean of the blood glucose in mmol/L at weeks 4, 8, 12, 24, 36, 44 and 52. Mixed model used baseline blood glucose as a covariate.

Secondary Outcome Measures

Trough Forced Expiratory Volume in 1 Second (FEV1) After 12, 24 and 52 Weeks
Trough FEV1 was defined as the mean of the values at 23 h 10 min and 23 h 45 min after dosing at clinic on the previous day. Trough FEV1 was analyzed after 12, 24 and 52 weeks using a mixed model which contained the baseline FEV1 measurement, FEV1 prior to inhalation and FEV1 30 minutes post inhalation of salbutamol as covariates.

Full Information

First Posted
April 3, 2009
Last Updated
October 4, 2011
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00876694
Brief Title
Confirmatory Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official Title
A 52-week Treatment, Multi-center, Randomized, Open Label, Parallel Group Study to Assess the Long Term Safety and Efficacy of Indacaterol (300 µg o.d.) Using Salmeterol (50 µg b.i.d.) as an Active Control in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 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 is designed to collect long term safety data of indacaterol (300 µg o.d.) in Japanese patients with moderate to severe COPD. Data from this study will be used for the registration of indacaterol in Japan.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
COPD, Chronic Obstructive Pulmonary Disease, Indacaterol, long acting β2-agonist

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
186 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Indacaterol 300 µg
Arm Type
Experimental
Arm Description
Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
Arm Title
Salmeterol 50 µg
Arm Type
Active Comparator
Arm Description
Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
Intervention Type
Drug
Intervention Name(s)
Indacaterol 300 µg
Intervention Description
Indacaterol 300 µg once daily (od) via SDDPI
Intervention Type
Drug
Intervention Name(s)
Salmeterol 50 µg
Intervention Description
Salmeterol 50 µg twice daily (bid) via Diskus®
Primary Outcome Measure Information:
Title
The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment
Description
The number of participants with newly occurring or worsening clinically notable vital sign: Pulse Rate in beats per minute (bpm) at anytime post baseline (BL) by treatment. Low Pulse Rate was defined as a pulse rate <40 bpm or <= to 50 bpm and a decrease from baseline >= to 15 bpm. High Pulse Rate was defined as a pulse rate >130 bpm or >= to 120 bpm and an increase from baseline >= to 15 bpm.
Time Frame
52 weeks
Title
The Number of Participants With a Clinically Notable Systolic Blood Pressure During 52 Weeks of Treatment
Description
The number of participants with newly occurring or worsening clinically notable vital sign: Systolic Blood Pressure (mmHg) at anytime post baseline (BL) by treatment. A Low Systolic Blood Pressure was defined as a systolic blood pressure measurement: <75 mmHg or <= to 90 mmHg and a decrease from baseline >= to 20 mmHg. A High Systolic Blood Pressure was defined as a systolic blood pressure measurement: >200 mmHg or >= to 180 mmHg and an increase from baseline >= to 20 mmHg.
Time Frame
52 weeks
Title
The Number of Participants With a Clinically Notable Diastolic Blood Pressure During 52 Weeks of Treatment
Description
The number of participants with newly occurring or worsening clinically notable vital sign: Diastolic blood pressure (mmHg) at anytime post baseline (BL) by treatment. A Low Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: <40 mmHg or <= to 50 mmHg and a decrease from baseline >= to 15 mmHg. A High Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: >115 mmHg or >= to 105 mmHg and an increase from baseline >= to 15 mmHg.
Time Frame
52 weeks
Title
The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment
Description
The number of participants with newly occurring or worsening clinically notable QTc Interval value at anytime post baseline. The QTc interval is calculated using Fridericia's formula: QTc= QT/cube root RR. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves in milliseconds (ms). Notable QTc interval >450 ms for males and >470 ms for females. The maximum QTc increase from baseline at any time during the study was also tabulated with absolute and relative frequencies for categories 30- 60 ms and >60 ms.
Time Frame
52 weeks
Title
Serum Potassium (mmol/L) at Weeks 4, 8, 12, 24, 36, 44, and 52
Description
The least squares mean of the serum potassium in mmol/L at weeks 4, 8, 12, 24, 36, 44 and 52. Mixed model used baseline serum potassium as a covariate.
Time Frame
4, 8, 12, 24, 36, 44, and 52 weeks
Title
Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 4, 8, 12, 24, 36, 44, and 52
Description
The least squares mean of the blood glucose in mmol/L at weeks 4, 8, 12, 24, 36, 44 and 52. Mixed model used baseline blood glucose as a covariate.
Time Frame
4, 8, 12, 24, 36, 44, and 52 weeks
Secondary Outcome Measure Information:
Title
Trough Forced Expiratory Volume in 1 Second (FEV1) After 12, 24 and 52 Weeks
Description
Trough FEV1 was defined as the mean of the values at 23 h 10 min and 23 h 45 min after dosing at clinic on the previous day. Trough FEV1 was analyzed after 12, 24 and 52 weeks using a mixed model which contained the baseline FEV1 measurement, FEV1 prior to inhalation and FEV1 30 minutes post inhalation of salbutamol as covariates.
Time Frame
After 12, 24 and 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines) 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 1 or during the run-in period Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1 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 Patients with a history of certain cardiovascular comorbid conditions Patients who have been exposed to indacaterol previously. (Except for any patient who enrolled in Study CQAB149B1302) Other protocol-defined inclusion/exclusion criteria may apply
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 Investigator Site
City
Asahikawa
Country
Japan
Facility Name
Novartis Investigator Site
City
Bunkyo-ku
Country
Japan
Facility Name
Novartis Investigator Site
City
Gifu
Country
Japan
Facility Name
Novartis Investigator Site
City
Hamamatsu
Country
Japan
Facility Name
Novartis Investigator Site
City
Himeji
Country
Japan
Facility Name
Novartis Investigator Site
City
Hiroshima
Country
Japan
Facility Name
Novartis Investigator Site
City
Iwata
Country
Japan
Facility Name
Novartis Investigator Site
City
Kanazawa
Country
Japan
Facility Name
Novartis Investigator Site
City
Kasaoka
Country
Japan
Facility Name
Novartis Investigator Site
City
Kawasaki
Country
Japan
Facility Name
Novartis Investigator Site
City
Kishiwada
Country
Japan
Facility Name
Novartis Investigator Site
City
Kitakyushu
Country
Japan
Facility Name
Novartis Investigator Site
City
Kochi
Country
Japan
Facility Name
Novartis Investigator Site
City
Koga
Country
Japan
Facility Name
Novartis Investigator Site
City
Kurume
Country
Japan
Facility Name
Novartis Investigator Site
City
Kyoto
Country
Japan
Facility Name
Novartis Investigator Site
City
Maebashi
Country
Japan
Facility Name
Novartis Investigator Site
City
Matsusaka-city
Country
Japan
Facility Name
Novartis Investigator Site
City
Morioka
Country
Japan
Facility Name
Novartis Investigator Site
City
Nagaoka-city
Country
Japan
Facility Name
Novartis Investigator Site
City
Nagoya
Country
Japan
Facility Name
Novartis Investigator Site
City
Naka-gun
Country
Japan
Facility Name
Novartis Investigator Site
City
Noda
Country
Japan
Facility Name
Novartis Investigator Site
City
Obihiro
Country
Japan
Facility Name
Novartis Investigator Site
City
Sakai
Country
Japan
Facility Name
Novartis Investigator site
City
Sapporo
Country
Japan
Facility Name
Novartis Investigator Site
City
Sendai
Country
Japan
Facility Name
Novartis Investigator Site
City
Setagaya-ku
Country
Japan
Facility Name
Novartis Investigator Site
City
Sumida-ku
Country
Japan
Facility Name
Novartis Investigator Site
City
Tenri
Country
Japan
Facility Name
Novartis Investigator Site
City
Tokyo
Country
Japan
Facility Name
Novartis Investigator Site
City
Ube
Country
Japan
Facility Name
Novartis Investigator Site
City
Wakayama
Country
Japan
Facility Name
Novartis Investigator Site
City
Yabu
Country
Japan
Facility Name
Novartis Investigator Site
City
Yanagawa
Country
Japan
Facility Name
Novartis Investigator Site
City
Yokkaichi
Country
Japan
Facility Name
Novartis Investigator Site
City
Yokohama
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Confirmatory Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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