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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00876694
First received: April 3, 2009
Last updated: October 4, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: Indacaterol 300 µg
Drug: Salmeterol 50 µg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 4, 8, 12, 24, 36, 44, and 52 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 4, 8, 12, 24, 36, 44, and 52 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: After 12, 24 and 52 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 186
Study Start Date: March 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Indacaterol 300 µg
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.
Drug: Indacaterol 300 µg
Indacaterol 300 µg once daily (od) via SDDPI
Active Comparator: Salmeterol 50 µg
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.
Drug: Salmeterol 50 µg
Salmeterol 50 µg twice daily (bid) via Diskus®

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00876694

Locations
Japan
Novartis Investigator Site
Asahikawa, Japan
Novartis Investigator Site
Bunkyo-ku, Japan
Novartis Investigator Site
Gifu, Japan
Novartis Investigator Site
Hamamatsu, Japan
Novartis Investigator Site
Himeji, Japan
Novartis Investigator Site
Hiroshima, Japan
Novartis Investigator Site
Iwata, Japan
Novartis Investigator Site
Kanazawa, Japan
Novartis Investigator Site
Kasaoka, Japan
Novartis Investigator Site
Kawasaki, Japan
Novartis Investigator Site
Kishiwada, Japan
Novartis Investigator Site
Kitakyushu, Japan
Novartis Investigator Site
Kochi, Japan
Novartis Investigator Site
Koga, Japan
Novartis Investigator Site
Kurume, Japan
Novartis Investigator Site
Kyoto, Japan
Novartis Investigator Site
Maebashi, Japan
Novartis Investigator Site
Matsusaka-city, Japan
Novartis Investigator Site
Morioka, Japan
Novartis Investigator Site
Nagaoka-city, Japan
Novartis Investigator Site
Nagoya, Japan
Novartis Investigator Site
Naka-gun, Japan
Novartis Investigator Site
Noda, Japan
Novartis Investigator Site
Obihiro, Japan
Novartis Investigator Site
Sakai, Japan
Novartis Investigator site
Sapporo, Japan
Novartis Investigator Site
Sendai, Japan
Novartis Investigator Site
Setagaya-ku, Japan
Novartis Investigator Site
Sumida-ku, Japan
Novartis Investigator Site
Tenri, Japan
Novartis Investigator Site
Tokyo, Japan
Novartis Investigator Site
Ube, Japan
Novartis Investigator Site
Wakayama, Japan
Novartis Investigator Site
Yabu, Japan
Novartis Investigator Site
Yanagawa, Japan
Novartis Investigator Site
Yokkaichi, Japan
Novartis Investigator Site
Yokohama, Japan
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00876694     History of Changes
Other Study ID Numbers: CQAB149B1303
Study First Received: April 3, 2009
Results First Received: October 4, 2011
Last Updated: October 4, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:
COPD, Chronic Obstructive Pulmonary Disease, Indacaterol, long acting β2-agonist

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Salmeterol
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014