Chronic Obstructive Pulmonary Disease (COPD)Phase 3NCT00792805
Efficacy and Safety of Indacaterol in Adults (40 Years and Above) With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study testing Indacaterol 150 µg and Indacaterol 300 μg in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis Pharmaceuticals at 15 sites in 3 countries.
Trial summary
This study evaluated the efficacy and safety of two doses of indacaterol in adults aged 40 or over with chronic obstructive pulmonary disease (COPD) in China and in two other countries. 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 and Indacaterol 300 μg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 563 participants
- Where
- 15 sitesin 3 countries
- Study dates
- Nov 2008to Feb 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
- Adults aged ≥ 40 years
- Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate to severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and:
- Smoking history of at least 10 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 received systemic corticosteroids for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period
- 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 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
15 sites in 3 countries.
15 sites in 3 countries
China10 sites
Novartis Investigative Site
Beijing
Novartis Investigative Site
Changsha
Novartis Investigative Site
Chongqing
Novartis Investigator Site
Fuzhou
Novartis Investigative Site
Guangzhou
Novartis Investigative Site
Shandong
Novartis Investigative Site
Shanghai
Novartis Investigative Site
Shenyang
Novartis Investigative Site
Shijiazhuang
Novartis Investigative Site
Xi'an
Australia3 sites
Novartis Investigative Site
Adelaide
Novartis Investigative Site
Clayton
Novartis Investigative Site
Daw Park
India2 sites
Novartis Investigative Site
Bangalore
Novartis Investigative Site
Trivandrum
About this study
Official title: A Phase III, 26-week 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)
This study evaluated the efficacy and safety of two doses of indacaterol in adults aged 40 or over with chronic obstructive pulmonary disease (COPD) in China and in two other countries.
- Being tested
- Indacaterol 150 µg, Indacaterol 300 μg, Placebo to indacaterol
- Keywords
- COPD, indacaterol, long-acting β2-agonist, adults
- 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 µgDrug
Indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).
Indacaterol 300 μgDrug
Indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).
Placebo to indacaterolDrug
Placebo to indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).
| Study group | Role | What they receive |
|---|---|---|
| Indacaterol 150 μg | Experimental | Patients inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. 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 |
| Indacaterol 300 μg | Experimental | Patients inhaled indacaterol 300 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. 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 |
| Placebo to indacaterol | Placebo comparator | Patients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. 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 to indacaterol |
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) at 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 and FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening as covariates.
Measured: Week 12 + 1 day, Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionFeb 2010
- Study completionFeb 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.
- 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
- 563 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00792805
- Sponsor's protocol ID
- CQAB149B2333
- Status last verified
- Jul 2011
- First submitted
- 17 Nov 2008
- Last updated
- 17 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Yao W, Wang C, Zhong N, Han X, Wu C, Yan X, Chen P, Yang W, Henley M, Kramer B. Effect of once-daily indacaterol in a predominantly Chinese population with chronic obstructive pulmonary disease: a 26-week Asia-Pacific study. Respirology. 2014 Feb;19(2):231-238. doi: 10.1111/resp.12211. Epub 2014 Jan 3.
PubMed 24383720
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 Phase III, 26-week 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
- NCT00792805
- Acronym / sponsor ID
- CQAB149B2333
- Keywords
- COPD, indacaterol, long-acting β2-agonist, adults
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 563 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 18 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.
This study evaluated the efficacy and safety of two doses of indacaterol in adults aged 40 or over with chronic obstructive pulmonary disease (COPD) in China and in two other countries.
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 µgPatients inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. 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 μgPatients inhaled indacaterol 300 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. 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 to indacaterol | Placebo comparator | Drug: Placebo to indacaterolPatients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. 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 (5 listed)
- Adults aged ≥ 40 years
- Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate to severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and:
Key exclusion criteria (12 listed)
- Patients who have received systemic corticosteroids for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period
- 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 µgIndacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI). | Drug | Indacaterol 150 μg |
| Indacaterol 300 μgIndacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI). | Drug | Indacaterol 300 μg |
| Placebo to indacaterolPlacebo to indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI). | Drug | Placebo to indacaterol |
Primary outcome
Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85
Time frame: 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 and FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening as covariates.
Results and safety
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 24383720Yao W, Wang C, Zhong N, Han X, Wu C, Yan X, Chen P, Yang W, Henley M, Kramer B. Effect of once-daily indacaterol in a predominantly Chinese population with chronic obstructive pulmonary disease: a 26-week Asia-Pacific study. Respirology. 2014 Feb;19(2):231-238. doi: 10.1111/resp.12211. Epub 2014 Jan 3.
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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
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Indacaterol 150 µg and Indacaterol 300 μg in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis Pharmaceuticals at 15 sites in 3 countries.
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 5 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 15 sites in China, Australia, India. 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) at Week 12 + 1 Day, Day 85 (time frame: 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 NCT00792805, 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.