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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00876694
• Other study ID #: CQAB149B1303
• Status: Completed
• Phase: Phase 3
• First received: April 3, 2009
• Last updated: October 4, 2011
• Start date: March 2009
• Est. completion date: October 2010

Study information

• Verified date: October 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Indacaterol 300 µg
Indacaterol 300 µg once daily (od) via SDDPI
• Salmeterol 50 µg
Salmeterol 50 µg twice daily (bid) via Diskus®

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	52 weeks	Yes
Primary	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.	52 weeks	Yes
Primary	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.	52 weeks	Yes
Primary	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.	52 weeks	Yes
Primary	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.	4, 8, 12, 24, 36, 44, and 52 weeks	Yes
Primary	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.	4, 8, 12, 24, 36, 44, and 52 weeks	Yes
Secondary	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.	After 12, 24 and 52 weeks	No