Chronic Obstructive Pulmonary DiseasePhase 3NCT01089127
Efficacy and Safety of Different Doses of Indacaterol in Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study testing Indacaterol and Salmeterol 50 μg in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 69 sites in United States.
Trial summary
This study compared the 14-day bronchodilator efficacy of indacaterol with that of placebo and salmeterol. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Indacaterol and Salmeterol 50 μg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 552 participants
- Where
- 69 sitesUnited States
- Study dates
- Mar 2010to Jul 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
- Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2008) 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 had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization in the 6 weeks prior to screening
- 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
- Any patient with lung cancer or a history of lung cancer
- Patients with a history of certain cardiovascular comorbid conditions
- Other protocol-defined inclusion/exclusion criteria applied to the study.
Trial locations and contacts
69 sites in 1 country.
69 sites in 1 country
United States69 sites
Novartis Investigative Site
Bayside, New York, 11361
Novartis Investigator Site
Bellevue, Nebraska, 68123
Novartis Investigator Site
Cadiz, Ohio, 43907
Novartis Investigator Site
Canton, Ohio, 44718
Novartis Investigative site
Charleston, South Carolina, 29406-7108
Novartis Investigative Site
Charleston, South Carolina, 29407
Novartis Investigative Site
Charlotte, North Carolina, 28207
Novartis Investigative Site
Cherry Hill, New Jersey, 08003
Novartis Investigator Site
Clearwater, Florida, 33765
Novartis Investigative Site
Columbia, Maryland, 21044
Novartis Investigator Site
Columbus, Ohio, 43215
Novartis Investigator Site
Cookeville, Tennessee, 38501
Novartis Investigator Site
DeFuniak Springs, Florida, 32435
Novartis Investigator Site
Dickinson, Texas, 77539
Novartis Investigative Site
Easley, South Carolina, 29640
Novartis Investigator Site
Edina, Minnesota, 55435
Novartis Investigative Site
Eugene, Oregon, 97404
Novartis Investigator Site
Florence, Alabama, 35630
Novartis Investigator Site
Florence, Kentucky, 41017
Novartis Investigator Site
Fort Worth, Texas, 76104
Novartis Investigative Site
Fredericksburg, Virginia, 22401
Novartis Investigator Site
Fridley, Minnesota, 55432
Novartis Investigator Site
Fullerton, California, 92835
Novartis Investigative Site
Glastonbury, Connecticut, 06033
Novartis Investigative Site
Great Neck, New York, 11023
Novartis Investigative Site
Greenville, South Carolina, 29615
Novartis Investigator Site
Henderson, Nevada, 89014
Novartis Investigative Site
Hollywood, Florida, 33021
Novartis Investigator Site
Jasper, Alabama, 35501
Novartis Investigative Site
Lake Success, New York, 11042
Novartis Investigative Site
Larchmont, New York, 10538
Novartis Investigator Site
Las Vegas, Nevada, 89119
Novartis Investigator Site
Las Vegas, Nevada, 89183
Novartis Investigator Site
Lebanon, New Hampshire, 03756
Novartis Investigator Site
Lincoln, Nebraska, 68510
Novartis Investigator Site
Madisonville, Kentucky, 42431
Novartis Investigator Site
McKinney, Texas, 75069
Novartis Investigator Site
Medford, Oregon, 97504
Novartis Investigator Site
Miami, Florida, 33145
Novartis Investigator Site
Minneapolis, Minnesota, 55402
Novartis Investigative site
Newport News, Virginia, 23606
Novartis Investigator Site
O'Fallon, Illinois, 62269
Novartis Investigator Site
Omaha, Nebraska, 68134
Novartis Investigator Site
Opelousas, Louisiana, 70570
Novartis Investigator Site
Ozark, Missouri, 65721
Novartis Investigative Site
Pensacola, Florida, 32503
Novartis Investigative Site
Pensacola, Florida, 32504
Novartis Investigator Site
Phoenix, Arizona, 85006
Novartis Investigative Site
Phoenixville, Pennsylvania, 19460
Novartis Investigative Site
Pittsburgh, Pennsylvania, 15243
Novartis Investigative Site
Rancho Mirage, California, 92270
Novartis Investigative Site
Richmond, Virginia, 23229
Novartis Investigator Site
Riverside, California, 92506
Novartis Investigator Site
Salt Lake City, Utah, 84107
Novartis Investigator Site
San Diego, California, 92120
Novartis Investigator Site
Searcy, Arkansas, 72143
Novartis Investigative Site
Shelby, North Carolina, 28152
Novartis Investigative Site
Spartanburg, South Carolina, 29303
Novartis Investigator Site
St Louis, Missouri, 63141
Novartis Investigative Site
Stamford, Connecticut, 06902
Novartis Investigator Site
Stockton, California, 95207
Novartis Investigator Site
Tacoma, Washington, 98405
Novartis Investigative Site
Tamarac, Florida, 33321
Novartis Investigator Site
Tampa, Florida, 33603
Novartis Investigator Site
Temecula, California, 92591
Novartis Investigator Site
Toledo, Ohio, 43608
Novartis Investigative Site
Union, South Carolina, 29379
Novartis Investigator Site
Walnut Creek, California, 94598
Novartis Investigator Site
Wheat Ridge, Colorado, 80033
About this study
Official title: A Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Different Doses of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease, Using Salmeterol as an Active Control
This study compared the 14-day bronchodilator efficacy of indacaterol with that of placebo and salmeterol.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Indacaterol, Salmeterol 50 μg, Placebo to indacaterol, Placebo to salmeterol
- Keywords
- Indacaterol, COPD, salmeterol
- 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.
IndacaterolDrug
Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
Salmeterol 50 μgDrug
Salmeterol was supplied in the manufacturer's proprietary Diskus inhaler device.
Placebo to indacaterolDrug
Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
Placebo to salmeterolDrug
Placebo to salmeterol was supplied in the manufacturer's proprietary Diskus inhaler device.
| Study group | Role | What they receive |
|---|---|---|
| Indacaterol 18.75 μg | Experimental | Patients inhaled indacaterol 18.75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study. Receives: Drug: Indacaterol; Drug: Placebo to salmeterol |
| Indacaterol 37.5 μg | Experimental | Patients inhaled indacaterol 37.5 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study. Receives: Drug: Indacaterol; Drug: Placebo to salmeterol |
| Indacaterol 75 μg | Experimental | Patients inhaled indacaterol 75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study. Receives: Drug: Indacaterol; Drug: Placebo to salmeterol |
| Indacaterol 150 μg | Experimental | Patients inhaled indacaterol 150 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study. Receives: Drug: Indacaterol; Drug: Placebo to salmeterol |
| Salmeterol 50 μg | Active comparator | Patients inhaled salmeterol 50 μg twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. In addition, patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study. Receives: Drug: Salmeterol 50 μg; Drug: Placebo to indacaterol |
| Placebo | Placebo comparator | Patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study. Receives: Drug: Placebo to indacaterol; Drug: Placebo to salmeterol |
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 the Study (Week 2 + 1 Day, Day 15)
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 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
Measured: 24 hours post-dose at the end of the study (Week 2 + 1 day, Day 15)
Secondary outcomes (1)
Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 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 on Day 2. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
Measured: 24 hours post-dose on Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2010
- Study completionJul 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 DiseaseStudies 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
- 552 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
- NCT01089127
- Sponsor's protocol ID
- CQAB149B2356
- Status last verified
- Jul 2011
- First submitted
- 17 Mar 2010
- Last updated
- 19 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Different Doses of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease, Using Salmeterol as an Active Control
- ClinicalTrials.gov ID
- NCT01089127
- Acronym / sponsor ID
- CQAB149B2356
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Indacaterol, COPD, salmeterol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 552 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 18 Mar 2010 (estimated)
- Results
- Posted 19 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 compared the 14-day bronchodilator efficacy of indacaterol with that of placebo and salmeterol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Indacaterol 18.75 μg | Experimental | Drug: Indacaterol, Drug: Placebo to salmeterolPatients inhaled indacaterol 18.75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study. |
| Indacaterol 37.5 μg | Experimental | Drug: Indacaterol, Drug: Placebo to salmeterolPatients inhaled indacaterol 37.5 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study. |
| Indacaterol 75 μg | Experimental | Drug: Indacaterol, Drug: Placebo to salmeterolPatients inhaled indacaterol 75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study. |
| Indacaterol 150 μg | Experimental | Drug: Indacaterol, Drug: Placebo to salmeterolPatients inhaled indacaterol 150 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study. |
| Salmeterol 50 μg | Active comparator | Drug: Salmeterol 50 μg, Drug: Placebo to indacaterolPatients inhaled salmeterol 50 μg twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. In addition, patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study. |
| Placebo | Placebo comparator | Drug: Placebo to indacaterol, Drug: Placebo to salmeterolPatients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) 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 chronic obstructive pulmonary disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2008) and:
Key exclusion criteria (8 listed)
- Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization in the 6 weeks prior to screening
- 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
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 |
|---|---|---|
| IndacaterolIndacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device. | Drug | Indacaterol 150 μg, Indacaterol 18.75 μg, Indacaterol 37.5 μg, Indacaterol 75 μg |
| Salmeterol 50 μgSalmeterol was supplied in the manufacturer's proprietary Diskus inhaler device. | Drug | Salmeterol 50 μg |
| Placebo to indacaterolPlacebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device. | Drug | Placebo, Salmeterol 50 μg |
| Placebo to salmeterolPlacebo to salmeterol was supplied in the manufacturer's proprietary Diskus inhaler device. | Drug | Indacaterol 150 μg, Indacaterol 18.75 μg, Indacaterol 37.5 μg, Indacaterol 75 μg, Placebo |
Primary outcome
Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 2 + 1 Day, Day 15)
Time frame: 24 hours post-dose at the end of the study (Week 2 + 1 day, Day 15)
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 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
1 secondary outcome
Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2
Time frame: 24 hours post-dose on Day 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
69 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 and Salmeterol 50 μg in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 69 sites in United States.
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 8 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 19 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 69 sites in United States. 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 19 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 the Study (Week 2 + 1 Day, Day 15) (time frame: 24 hours post-dose at the end of the study (Week 2 + 1 day, Day 15)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2011.