Chronic Obstructive Pulmonary Disease (COPD)Phase 3NCT00794157

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

A Phase 3 study testing Indacaterol 150 μg capsules and Indacaterol 300 μg capsules in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis Pharmaceuticals at 60 sites in 6 countries.

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 was designed to provide pivotal confirmation of efficacy and safety data for 2 doses of indacaterol (150 and 300 µg once daily [od]) in patients with moderate to severe chronic obstructive pulmonary disease (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 150 μg capsules and Indacaterol 300 μg capsules
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 347 participants
Where: 60 sitesin 6 countries
Study dates: Nov 2008to Oct 2009
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

Diagnosis of moderate-to-severe chronic obstructive pulmonary disease (COPD), as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines and:
Smoking history of at least 20 pack-years.
Post-bronchodilator forced expiratory volume in 1 second (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 screening or during the 14 day run-in period prior to randomization.
Patients requiring long-term oxygen therapy (> 15 hours a day) for chronic hypoxemia.
Patients who have had a respiratory tract infection within 6 weeks prior to screening.
Patients with concomitant pulmonary disease.
Patients with a history of asthma.
Patients with diabetes Type I or uncontrolled diabetes Type II.

Show all 12Show fewer

Any patient with lung cancer or a history of lung cancer.
Any patient with active cancer or a history of cancer with less than 5 years disease-free survival time.
Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured at screening or randomization is prolonged.
Patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period.
Patients unable to successfully use a dry powder inhaler device or perform spirometry measurements.
Other protocol-defined inclusion/exclusion criteria applied to the study.

Trial locations and contacts

60 sites in 6 countries.

Country

City, postcode or hospital

60 sites in 6 countries

Japan34 sites

Novartis Investigative Site
Asahikawa
Novartis Investigative Site
Bunkyō City
Novartis Investigator Site
Gifu
Novartis Investigator Site
Himeji
Novartis Investigator Site
Hiroshima
Novartis Investigator Site
Iwata
Novartis Investigator Site
Kanazawa
Novartis Investigative site
Kawasaki
Novartis Investigator Site
Kishiwada
Novartis Investigator Site
Kitakyushu
Novartis Investigator Site
Kochi
Novartis Investigator Site
Koga
Novartis Investigative Site
Kurume
Novartis Investigator Site
Kyoto
Novartis Investigative Site
Maebashi
Novartis Investigator Site
Matsusaka
Novartis Investigative Site
Morioka
Novartis Investigator Site
Nagaoka
Novartis Investigator Site
Nagoya
Novartis Investigative Site
Noda
Novartis Investigative Site
Obihiro
Novartis Investigator Site
Sakai
Novartis Investigative Site
Sapporo
Novartis Investigator Site
Sendai
Novartis Investigator Site
Seto
Novartis Investigator Site
Tenri
Novartis Investigative site
Tokyo
Novartis Investigator Site
Toyonaka
Novartis Investigator Site
Ube
Novartis Investigator Site
Wakayama
Novartis Investigator Site
Yabu
Novartis Investigator Site
Yanagawa
Novartis Investigator Site
Yokkaichi
Novartis Investigative Site
Yokohama

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Taiwan10 sites

Novartis Investigator Site
Chiayi City
Novartis Investigator Site
Kaohsiung City
Novartis Investigative Site
Keelung
Novartis Investigative Site
Linkou District
Novartis Investigative Site
Taichung
Novartis Investigator Site
Taichung
Novartis Investigative Site
Taipei
Novartis Investigator Site
Taipei
Novartis Investigator Site
Taipei County
Novartis Investigator Site
Xindian District

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India7 sites

Novartis Investigative Site
Ahmedabad
Novartis Investigator Site
Bangalore
Novartis Investigative Site
Coimbatore
Novartis Investigator Site
Coimbatore
Novartis Investigator Site
India
Novartis Investigative Site
Mumbai
Novartis Investigative Center
Panjim

Other trials in India

South Korea6 sites

Novartis Investigator Site
Daegu
Novartis Investigator Site
Junggu
Novartis Investigative Site
Kangwon-Do
Novartis Investigator Site
Pusan
Novartis Investigative Site
Seoul
Novartis Investigator Site
Seoul

Other trials in South Korea

Hong Kong2 sites

Novartis Investigator Site
Hong Kong
Novartis Investigator Site
New Territories

Other trials in Hong Kong

Singapore1 site

Novartis Investigator Site
Singapore

Other trials in Singapore

About this study

Official title: A 12-week Treatment, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol (150 and 300 µg Once Daily [od]) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Being tested: Indacaterol 150 μg capsules, Indacaterol 300 μg capsules, Placebo capsules
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 150 μg capsulesDrug
Indacaterol was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI).
Indacaterol 300 μg capsulesDrug
Indacaterol was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI).
Placebo capsulesDrug
Placebo was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI).

Study groups in NCT00794157
Study group	Role	What they receive
Indacaterol 150 µg	Experimental	Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. Receives: Drug: Indacaterol 150 μg capsules
Indacaterol 300 µg	Experimental	Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. Receives: Drug: Indacaterol 300 μg capsules
Placebo	Placebo comparator	Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. Receives: Drug: Placebo capsules

What is being measured

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

Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85)
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.
Measured: End of treatment (Week 12 + 1 day, Day 85)

Secondary outcomes (4)

Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 2. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.
Measured: After Week 2 (Day 15)
Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 4. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.
Measured: After Week 4 (Day 29)
Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 8
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 8. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.
Measured: After Week 8 (Day 57)
Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (Day 84)
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 50 and 15 minutes pre-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.
Measured: Prior to last dose at Week 12 (Day 84)

Timeline

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

Nov 2008Oct 2009

First posted19 Nov 2008 (estimated)
Study startNov 2008
Primary completionOct 2009
Study completionOct 2009

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.
Publications (1)Papers the sponsor has linked to this study.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 347 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00794157
Sponsor's protocol ID: CQAB149B1302
Status last verified: Jul 2011
First submitted: 17 Nov 2008
Last updated: 17 Aug 2011
Results posted: Yes, on ClinicalTrials.gov

Publications

To Y, Kinoshita M, Lee SH, Hang LW, Ichinose M, Fukuchi Y, Kitawaki T, Okino N, Prasad N, Lawrence D, Kramer B. Assessing efficacy of indacaterol in moderate and severe COPD patients: a 12-week study in an Asian population. Respir Med. 2012 Dec;106(12):1715-21. doi: 10.1016/j.rmed.2012.09.002. Epub 2012 Oct 5.
PubMed 23040786

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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Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 12-week Treatment, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol (150 and 300 µg Once Daily [od]) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov ID: NCT00794157
Acronym / sponsor ID: CQAB149B1302
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: 347 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Nov 2008
Primary completion: Oct 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 19 Nov 2008 (estimated)
Results: Posted 17 Aug 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: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Indacaterol 150 µg	Experimental	Drug: Indacaterol 150 μg capsulesPatients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Indacaterol 300 µg	Experimental	Drug: Indacaterol 300 μg capsulesPatients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Placebo	Placebo comparator	Drug: Placebo capsulesPatients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the 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)

Diagnosis of moderate-to-severe chronic obstructive pulmonary disease (COPD), as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines and:

Key exclusion criteria (12 listed)

Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to screening or during the 14 day run-in period prior to randomization.
Patients requiring long-term oxygen therapy (> 15 hours a day) for chronic hypoxemia.
Patients who have had a respiratory tract infection within 6 weeks prior to screening.
Patients with concomitant pulmonary disease.
Patients with a history of asthma.

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 150 μg capsulesIndacaterol was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI).	Drug	Indacaterol 150 µg
Indacaterol 300 μg capsulesIndacaterol was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI).	Drug	Indacaterol 300 µg
Placebo capsulesPlacebo was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI).	Drug	Placebo

Primary outcome

Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85)
Time frame: End of treatment (Week 12 + 1 day, Day 85)
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.

4 secondary outcomes

Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2
Time frame: After Week 2 (Day 15)
Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4
Time frame: After Week 4 (Day 29)
Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 8
Time frame: After Week 8 (Day 57)
Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (Day 84)
Time frame: Prior to last dose at Week 12 (Day 84)

Results and safety

Results posted to the registry on 17 Aug 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 150 μg	114	104
Indacaterol 300 μg	116	106
Placebo	117	98

Primary outcome: Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85)

Time frame: End of treatment (Week 12 + 1 day, Day 85). Least squares mean (Standard Error). Unit: Liters

Measure	Indacaterol 150 μg n = 109	Indacaterol 300 μg n = 110	Placebo n = 104
Value	1.34 (0.024)	1.37 (0.023)	1.17 (0.025)

Population analysed: Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. The imputation technique used as last observation carried forward (LOCF).

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Indacaterol 150 μg	4 of 114 (3.5%)	24 of 114 (21.1%)	Not reported
Indacaterol 300 μg	2 of 116 (1.7%)	26 of 116 (22.4%)	Not reported
Placebo	6 of 117 (5.1%)	26 of 117 (22.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23040786To Y, Kinoshita M, Lee SH, Hang LW, Ichinose M, Fukuchi Y, Kitawaki T, Okino N, Prasad N, Lawrence D, Kramer B. Assessing efficacy of indacaterol in moderate and severe COPD patients: a 12-week study in an Asian population. Respir Med. 2012 Dec;106(12):1715-21. doi: 10.1016/j.rmed.2012.09.002. Epub 2012 Oct 5.

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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

60 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 12 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 17 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in Japan, Taiwan, India, South Korea, Hong Kong and 1 more country. 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. Some participants in this study may receive a placebo. 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 17 Aug 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?

Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85) (time frame: End of treatment (Week 12 + 1 day, Day 85)). 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 NCT00794157, which also lists 1 linked publication.

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 17 Aug 2011.