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

NCT00876694 | Completed Phase 3 Results

• 1 other identifier: CQAB149B1303
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 37

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD, Chronic Obstructive Pulmonary Disease, Indacaterol, long acting β2-agonist

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Secondary Outcomes (1)

• Trough Forced Expiratory Volume in 1 Second (FEV1) After 12, 24 and 52 Weeks

  After 12, 24 and 52 weeks

Study Arms (2)

Indacaterol 300 µg

EXPERIMENTAL

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

Salmeterol 50 µg

ACTIVE COMPARATOR

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

Interventions

Indacaterol 300 µg DRUG

Indacaterol 300 µg once daily (od) via SDDPI

Indacaterol 300 µg

Salmeterol 50 µg DRUG

Salmeterol 50 µg twice daily (bid) via Diskus®

Salmeterol 50 µg

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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%

You may not qualify if:

• 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)

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (37)

Novartis Investigator Site

Asahikawa, Japan

Location

Novartis Investigator Site

Bunkyō City, Japan

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Gifu, Japan

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Hamamatsu, Japan

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Himeji, Japan

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Hiroshima, Japan

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Iwata, Japan

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Kanazawa, Japan

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Kasaoka, Japan

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Kawasaki, Japan

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Kishiwada, Japan

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Kitakyushu, Japan

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Kochi, Japan

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Koga, Japan

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Kurume, Japan

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Kyoto, Japan

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Maebashi, Japan

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Matsusaka, Japan

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Morioka, Japan

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Nagaoka, Japan

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Nagoya, Japan

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Naka-gun, Japan

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Noda, Japan

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Obihiro, Japan

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Sakai, Japan

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Sapporo, Japan

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Sendai, Japan

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Setagaya-ku, Japan

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Sumida-ku, Japan

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Tenri, Japan

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Tokyo, Japan

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Ube, Japan

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Wakayama, Japan

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Yabu, Japan

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Yanagawa, Japan

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Yokkaichi, Japan

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Yokohama, Japan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol; Salmeterol Xinafoate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2009
• First Posted: April 7, 2009
• Study Start: March 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: November 8, 2011
• Results First Posted: November 8, 2011

Record last verified: 2011-10

Locations

JP (37)