Chronic Obstructive Pulmonary DiseasePhase 3NCT00620022
The Effect of Indacaterol on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
A Phase 3 study testing Indacaterol 300 μg in people with Chronic Obstructive Pulmonary Disease, run by Novartis at 20 sites in 6 countries.
Trial summary
This study compared the effect of indacaterol (300 μg once daily [od]) on exercise endurance with that of placebo in patients with moderate to severe chronic obstructive pulmonary disease. 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 300 μg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 20 sitesin 6 countries
- Study dates
- Apr 2008to Jan 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
- Male and female adults aged ≥ 40 years, who have signed an informed consent form prior to initiation of any study-related procedure.
- Co-operative outpatients with a diagnosis of moderate to severe chronic obstructive pulmonary disease (COPD), as classified by the GOLD Guidelines (2006), 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/forced vital capacity (FVC) < 70%.
Who cannot join
- Pregnant or nursing (lactating) women.
- Women of child-bearing potential.
- Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period.
- Patients requiring oxygen therapy or who experience oxygen desaturation to < 80% during cycle exercise on room air.
- Patients with a Wmax value < 20 W (as determined by the incremental cycle endurance test) at screening.
- Patients who have had a respiratory tract infection within 6 weeks prior to screening.
Show all 16Show fewer
- Patients with contra-indications of cardiopulmonary exercise testing.
- Patients with concomitant pulmonary disease.
- Patients with a history (up to and including the screening visit) of asthma.
- Patients with diabetes Type I or uncontrolled diabetes Type II.
- 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 the collection of informed consent visit (Visit 1) 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, metered dose inhaler (MDI), or perform spirometry measurements.
- Other protocol-defined inclusion/exclusion criteria applied to the study.
Trial locations and contacts
20 sites in 6 countries.
20 sites in 6 countries
Spain5 sites
Novartis Investigator Site
Alicante
Novartis Investigator Site
Barcelona
Novartis Investigative Site
Madrid
Novartis Investigative site
Seville
Novartis Investigator Site
Zaragoza
Belgium4 sites
Novartis Investigator Site
Brussels
Novartis Investigator Site
Gembloux
Novartis Investigator Site
Jette
Novartis Investigator Site
Liège
Denmark4 sites
Novartis Investigator Site
Aarhus
Novartis Investigative Site
Hellerup
Novartis Investigator Site
Hvidovre
Novartis Investigative site
Odense
Italy3 sites
Novartis Investigator Site
Genova
Novartis Investigator Site
Pisa
Novartis Investigator Site
Verona
United States2 sites
Novartis Investigator Site
Lebanon, New Hampshire
Novartis Investigator Site
Torrance, California
Canada2 sites
Novartis Investigator Site
Edmonton
Novartis Investigator Site
Kingston
About this study
Official title: A Phase III Randomized, Double-blind, Placebo-controlled, 2-period Crossover, Multicenter Study to Assess the Effect of Indacaterol (300 μg o.d.) on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
This study compared the effect of indacaterol (300 μg once daily [od]) on exercise endurance with that of placebo in patients with moderate to severe chronic obstructive pulmonary disease.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Indacaterol 300 μg, Placebo
- Keywords
- indacaterol, chronic obstructive pulmonary disease, exercise endurance, moderate to severe chronic obstructive pulmonary disease, COPD
- 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 was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
PlaceboDrug
Placebo was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
| Study group | Role | What they receive |
|---|---|---|
| Indacaterol 300 μg followed by placebo | Experimental | Patients first received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. After a 3-week washout period, patients received placebo delivered od via a SDDPI in the morning for 3 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; Drug: Placebo |
| Placebo followed by indacaterol 300 μg | Experimental | Patients first received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. After a 3-week washout period, patients received indacaterol 300 μg delivered od via a SDDPI in the morning for 3 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; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Duration Time Assessed by Constant-load Cycle Ergometry at the End of Each Treatment Period
At the end of each 3 week treatment period, patients completed constant-load cycle ergometry testing at a work-rate of 75% of the Wmax determined at Screening. This work-rate was maintained until symptom limitation caused the patient to stop exercising. The time from the start of loaded pedaling until the patient stopped exercising was recorded.
Measured: End of each 3 week treatment period (last day of Weeks 3 and 9)
Secondary outcomes (1)
Inspiratory Capacity (IC) Assessed at Rest With Spirometry at the End of Each Treatment Period 60 Minutes Pre-dose
At the end of each 3 week treatment period 60 minutes before inhalation of study drug, IC was measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters.
Measured: End of each 3 week treatment period (last day of Weeks 3 and 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2008 (estimated)
- Study startApr 2008
- Primary completionJan 2009
- Study completionJan 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 DiseaseStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharma, Study chair, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00620022
- Sponsor's protocol ID
- CQAB149B2311
- Status last verified
- Jul 2011
- First submitted
- 8 Feb 2008
- Last updated
- 17 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
O'Donnell DE, Casaburi R, Vincken W, Puente-Maestu L, Swales J, Lawrence D, Kramer B; INABLE 1 study group. Effect of indacaterol on exercise endurance and lung hyperinflation in COPD. Respir Med. 2011 Jul;105(7):1030-6. doi: 10.1016/j.rmed.2011.03.014. Epub 2011 Apr 16.
PubMed 21498063
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 Randomized, Double-blind, Placebo-controlled, 2-period Crossover, Multicenter Study to Assess the Effect of Indacaterol (300 μg o.d.) on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT00620022
- Acronym / sponsor ID
- CQAB149B2311
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- indacaterol, chronic obstructive pulmonary disease, exercise endurance, moderate to severe chronic obstructive pulmonary disease, COPD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 21 Feb 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 compared the effect of indacaterol (300 μg once daily [od]) on exercise endurance with that of placebo in patients with moderate to severe chronic obstructive pulmonary disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indacaterol 300 μg followed by placebo | Experimental | Drug: Indacaterol 300 μg, Drug: PlaceboPatients first received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. After a 3-week washout period, patients received placebo delivered od via a SDDPI in the morning for 3 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 followed by indacaterol 300 μg | Experimental | Drug: Indacaterol 300 μg, Drug: PlaceboPatients first received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. After a 3-week washout period, patients received indacaterol 300 μg delivered od via a SDDPI in the morning for 3 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)
- Male and female adults aged ≥ 40 years, who have signed an informed consent form prior to initiation of any study-related procedure.
- Co-operative outpatients with a diagnosis of moderate to severe chronic obstructive pulmonary disease (COPD), as classified by the GOLD Guidelines (2006), and:
Key exclusion criteria (16 listed)
- Pregnant or nursing (lactating) women.
- Women of child-bearing potential.
- Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period.
- Patients requiring oxygen therapy or who experience oxygen desaturation to < 80% during cycle exercise on room air.
- Patients with a Wmax value < 20 W (as determined by the incremental cycle endurance test) at screening.
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 was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device. | Drug | Indacaterol 300 μg followed by placebo, Placebo followed by indacaterol 300 μg |
| PlaceboPlacebo was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device. | Drug | Indacaterol 300 μg followed by placebo, Placebo followed by indacaterol 300 μg |
Primary outcome
Exercise Duration Time Assessed by Constant-load Cycle Ergometry at the End of Each Treatment Period
Time frame: End of each 3 week treatment period (last day of Weeks 3 and 9)
At the end of each 3 week treatment period, patients completed constant-load cycle ergometry testing at a work-rate of 75% of the Wmax determined at Screening. This work-rate was maintained until symptom limitation caused the patient to stop exercising. The time from the start of loaded pedaling until the patient stopped exercising was recorded.
1 secondary outcome
Inspiratory Capacity (IC) Assessed at Rest With Spirometry at the End of Each Treatment Period 60 Minutes Pre-dose
Time frame: End of each 3 week treatment period (last day of Weeks 3 and 9)
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 21498063O'Donnell DE, Casaburi R, Vincken W, Puente-Maestu L, Swales J, Lawrence D, Kramer B; INABLE 1 study group. Effect of indacaterol on exercise endurance and lung hyperinflation in COPD. Respir Med. 2011 Jul;105(7):1030-6. doi: 10.1016/j.rmed.2011.03.014. Epub 2011 Apr 16.
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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 Pharma study chair
Novartis Pharmaceuticals
20 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Indacaterol 300 μg in people with Chronic Obstructive Pulmonary Disease, run by Novartis at 20 sites in 6 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 16 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 20 sites in Spain, Belgium, Denmark, Italy, United States 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. 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?
Exercise Duration Time Assessed by Constant-load Cycle Ergometry at the End of Each Treatment Period (time frame: End of each 3 week treatment period (last day of Weeks 3 and 9)). 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 NCT00620022, 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.