Chronic Obstructive Pulmonary Disease (COPD)Phase 3NCT00876694

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

A Phase 3 study testing Indacaterol 300 µg and Salmeterol 50 µg in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis Pharmaceuticals at 37 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Chronic Obstructive Pulmonary Disease (COPD)
What is being tested?: Indacaterol 300 µg and Salmeterol 50 µg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 186 participants
Where: 37 sitesJapan
Study dates: Mar 2009to Oct 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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%

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

37 sites in 1 country.

City, postcode or hospital

37 sites in 1 country

Japan37 sites

Novartis Investigator Site
Asahikawa
Novartis Investigator Site
Bunkyō City
Novartis Investigator Site
Gifu
Novartis Investigator Site
Hamamatsu
Novartis Investigator Site
Himeji
Novartis Investigator Site
Hiroshima
Novartis Investigator Site
Iwata
Novartis Investigator Site
Kanazawa
Novartis Investigator Site
Kasaoka
Novartis Investigator Site
Kawasaki
Novartis Investigator Site
Kishiwada
Novartis Investigator Site
Kitakyushu
Novartis Investigator Site
Kochi
Novartis Investigator Site
Koga
Novartis Investigator Site
Kurume
Novartis Investigator Site
Kyoto
Novartis Investigator Site
Maebashi
Novartis Investigator Site
Matsusaka
Novartis Investigator Site
Morioka
Novartis Investigator Site
Nagaoka
Novartis Investigator Site
Nagoya
Novartis Investigator Site
Naka-gun
Novartis Investigator Site
Noda
Novartis Investigator Site
Obihiro
Novartis Investigator Site
Sakai
Novartis Investigator site
Sapporo
Novartis Investigator Site
Sendai
Novartis Investigator Site
Setagaya-ku
Novartis Investigator Site
Sumida-ku
Novartis Investigator Site
Tenri
Novartis Investigator Site
Tokyo
Novartis Investigator Site
Ube
Novartis Investigator Site
Wakayama
Novartis Investigator Site
Yabu
Novartis Investigator Site
Yanagawa
Novartis Investigator Site
Yokkaichi
Novartis Investigator Site
Yokohama

Other trials in Japan

About this study

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)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Being tested: Indacaterol 300 µg, Salmeterol 50 µg
Keywords: COPD, Chronic Obstructive Pulmonary Disease, Indacaterol, long acting β2-agonist
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00876694
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Salmeterol 50 µg

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: After 12, 24 and 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2009Oct 2010

First posted7 Apr 2009 (estimated)
Study startMar 2009
Primary completionOct 2010
Study completionOct 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 186 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00876694
Sponsor's protocol ID: CQAB149B1303
Status last verified: Oct 2011
First submitted: 3 Apr 2009
Last updated: 8 Nov 2011
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Obstructive Pulmonary Disease (COPD) trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT00876694
Acronym / sponsor ID: CQAB149B1303
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD, Chronic Obstructive Pulmonary Disease, Indacaterol, long acting β2-agonist
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 186 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Mar 2009
Primary completion: Oct 2010 (actual)
Study completion: Oct 2010 (actual)
First posted: 7 Apr 2009 (estimated)
Results: Posted 8 Nov 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Indacaterol 300 µg	Experimental	Drug: Indacaterol 300 µgIndacaterol 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	Active comparator	Drug: Salmeterol 50 µgSalmeterol 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.

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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%

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Indacaterol 300 µgIndacaterol 300 µg once daily (od) via SDDPI	Drug	Indacaterol 300 µg
Salmeterol 50 µgSalmeterol 50 µg twice daily (bid) via Diskus®	Drug	Salmeterol 50 µg

Primary outcome

The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment
Time frame: 52 weeks
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
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
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
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
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
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.

1 secondary outcome

Trough Forced Expiratory Volume in 1 Second (FEV1) After 12, 24 and 52 Weeks
Time frame: After 12, 24 and 52 weeks

Results and safety

Results posted to the registry on 8 Nov 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Indacaterol 300 μg	125	104
Salmeterol 50 μg	61	49

Primary outcome: The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment

Time frame: 52 weeks. Number. Unit: Participants

Measure	Indacaterol 300 μg n = 125	Salmeterol 50 μg n = 61
Low Pulse Rate:	1	0
High Pulse Rate:	0	0

Population analysed: The safety population included all patients who received at least one dose of study drug.

Primary outcome: The Number of Participants With a Clinically Notable Systolic Blood Pressure During 52 Weeks of Treatment

Time frame: 52 weeks. Number. Unit: Participants

Measure	Indacaterol 300 μg n = 125	Salmeterol 50 μg n = 61
Low Systolic Blood Pressure:	0	0
High Systolic Blood Pressure:	1	0

Population analysed: The safety population included all patients who received at least one dose of study drug.

Primary outcome: The Number of Participants With a Clinically Notable Diastolic Blood Pressure During 52 Weeks of Treatment

Time frame: 52 weeks. Number. Unit: Participants

Measure	Indacaterol 300 μg n = 125	Salmeterol 50 μg n = 61
Low Diastolic Blood Pressure:	0	1
High Diastolic Blood Pressure:	0	0

Population analysed: The safety population included all patients who received at least one dose of study drug.

Primary outcome: The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment

Time frame: 52 weeks. Number. Unit: Participants

Measure	Indacaterol 300 μg n = 125	Salmeterol 50 μg n = 61
Notable QTc	6	3
QTc increase from BL: 30-60 ms	12	3
QTc increase from BL: >60 ms	0	1

Population analysed: The safety population included all patients who received at least one dose of study drug.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 52 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Indacaterol 300 μg	16 of 125 (12.8%)	61 of 125 (48.8%)	Not reported
Salmeterol 50 μg	4 of 61 (6.6%)	26 of 61 (42.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Chronic Obstructive Pulmonary Disease (COPD)

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

37 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Indacaterol 300 µg and Salmeterol 50 µg in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis Pharmaceuticals at 37 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment (time frame: 52 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00876694.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2011.