Chronic Obstructive Pulmonary DiseasePhase 3NCT00999908
Comparison of the Effects of Indacaterol and Tiotropium on Inspiratory Capacity
A Phase 3 study testing Indacaterol 150 μg and Tiotropium 18 μg in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 11 sites in Italy.
Trial summary
This study compared the effects of a single dose of indacaterol with that of a single dose of tiotropium on inspiratory capacity. 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 150 μg and Tiotropium 18 μg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 11 sitesItaly
- Study dates
- Oct 2009to Mar 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 moderate (as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2007) chronic obstructive pulmonary disease (COPD) and:
- Smoking history of at least 10 pack-years.
- Forced expiratory volume in 1 second (FEV1) < 80% and ≥ 50% of the predicted normal value.
- Post-bronchodilator FEV1/Force vital capacity (FVC) < 0.7.
Who cannot join
- Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid treatment 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 alpha-1-antitrypsin deficiency.
- Patients with contraindications for tiotropium treatment.
- Patients with a history of hypersensitivity to any of the study drugs or to drugs from similar drug classes.
- Other protocol-defined inclusion/exclusion criteria applied to the study.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Italy11 sites
Novartis Investigative Site
Bergamo
Novartis Investigative Site
Brescia
Novartis Investigative Site
Cava de' Tirreni
Novartis Investigative Site
Genova
Novartis Investigative Site
Milan
Novartis Investigative Site
Orbassano
Novartis Investigative Site
Pavia
Novartis Investigative Site
Reggio Emilia
Novartis Investigative Site
Sesto San Giovanni
Novartis Investigative Site
Treviso
Novartis Investigative Site
Verona
About this study
Official title: Multicenter, Randomized, Blinded, Placebo-controlled, Crossover, Single-dose Study to Assess the Effect of Indacaterol (150 μg) Versus Tiotropium (18 μg) on Inspiratory Capacity in Moderate Chronic Obstructive Pulmonary Disease (COPD) Patients
This study compared the effects of a single dose of indacaterol with that of a single dose of tiotropium on inspiratory capacity.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Indacaterol 150 μg, Tiotropium 18 μg, Placebo
- Keywords
- COPD, indacaterol, tiotropium
- 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 together with a single dose dry powder inhaler (SDDPI) device.
Tiotropium 18 μgDrug
Tiotropium was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
PlaceboDrug
Placebo (matching indacaterol) was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
| Study group | Role | What they receive |
|---|---|---|
| Indacaterol 150 μg-tiotropium 18 μg-placebo | Experimental | Patients received indacaterol 150 μg once. After a 5-9 days washout period, patients received tiotropium 18 μg once. After a second 5-9 days washout period, patients received placebo (matching indacaterol) once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study. Receives: Drug: Indacaterol 150 μg; Drug: Tiotropium 18 μg; Drug: Placebo |
| Tiotropium 18 μg-placebo-indacaterol 150 μg | Experimental | Patients received tiotropium 18 μg once. After a 5-9 days washout period, patients received placebo (matching indacaterol) once. After a second 5-9 days washout period, patients received indacaterol 150 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study. Receives: Drug: Indacaterol 150 μg; Drug: Tiotropium 18 μg; Drug: Placebo |
| Placebo-indacaterol 150 μg-tiotropium 18 μg | Experimental | Patients received placebo (matching indacaterol) once. After a 5-9 days washout period, patients received indacaterol 150 μg once. After a second 5-9 days washout period, patients received tiotropium 18 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study. Receives: Drug: Indacaterol 150 μg; Drug: Tiotropium 18 μg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Inspiratory Capacity Assessed With Spirometry in the 4 Hours After Treatment
During the 4 hours following inhalation of the study treatment, inspiratory capacity (IC) was measured with spirometry conducted according to internationally accepted standards. IC was measured 3 times each at 30, 60, 120, 180, and 240 minutes post-dose and the highest value was reported in liters.
Measured: 4 hour period following inhalation of study treatment
Secondary outcomes (2)
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time.
Measured: 4 hour period following inhalation of study treatment
Force Vital Capacity (FVC) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment
FVC was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time.
Measured: 4 hour period following inhalation of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionMar 2010
- Study completionMar 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 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999908
- Sponsor's protocol ID
- CQAB149BIT01
- Other IDs
- 2009-013763-19, 2009
- Status last verified
- Feb 2016
- First submitted
- 21 Oct 2009
- Last updated
- 17 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Rossi A, Centanni S, Cerveri I, Gulotta C, Foresi A, Cazzola M, Brusasco V. Acute effects of indacaterol on lung hyperinflation in moderate COPD: a comparison with tiotropium. Respir Med. 2012 Jan;106(1):84-90. doi: 10.1016/j.rmed.2011.09.006. Epub 2011 Oct 27.
PubMed 22035851
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Blinded, Placebo-controlled, Crossover, Single-dose Study to Assess the Effect of Indacaterol (150 μg) Versus Tiotropium (18 μg) on Inspiratory Capacity in Moderate Chronic Obstructive Pulmonary Disease (COPD) Patients
- ClinicalTrials.gov ID
- NCT00999908
- Acronym / sponsor ID
- CQAB149BIT01
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, indacaterol, tiotropium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 22 Oct 2009 (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 effects of a single dose of indacaterol with that of a single dose of tiotropium on inspiratory capacity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Indacaterol 150 μg-tiotropium 18 μg-placebo | Experimental | Drug: Indacaterol 150 μg, Drug: Tiotropium 18 μg, Drug: PlaceboPatients received indacaterol 150 μg once. After a 5-9 days washout period, patients received tiotropium 18 μg once. After a second 5-9 days washout period, patients received placebo (matching indacaterol) once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study. |
| Tiotropium 18 μg-placebo-indacaterol 150 μg | Experimental | Drug: Indacaterol 150 μg, Drug: Tiotropium 18 μg, Drug: PlaceboPatients received tiotropium 18 μg once. After a 5-9 days washout period, patients received placebo (matching indacaterol) once. After a second 5-9 days washout period, patients received indacaterol 150 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study. |
| Placebo-indacaterol 150 μg-tiotropium 18 μg | Experimental | Drug: Indacaterol 150 μg, Drug: Tiotropium 18 μg, Drug: PlaceboPatients received placebo (matching indacaterol) once. After a 5-9 days washout period, patients received indacaterol 150 μg once. After a second 5-9 days washout period, patients received tiotropium 18 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol 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 (as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2007) chronic obstructive pulmonary disease (COPD) and:
Key exclusion criteria (7 listed)
- Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid treatment 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 alpha-1-antitrypsin deficiency.
- Patients with contraindications for tiotropium treatment.
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 together with a single dose dry powder inhaler (SDDPI) device. | Drug | Indacaterol 150 μg-tiotropium 18 μg-placebo, Placebo-indacaterol 150 μg-tiotropium 18 μg, Tiotropium 18 μg-placebo-indacaterol 150 μg |
| Tiotropium 18 μgTiotropium was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device. | Drug | Indacaterol 150 μg-tiotropium 18 μg-placebo, Placebo-indacaterol 150 μg-tiotropium 18 μg, Tiotropium 18 μg-placebo-indacaterol 150 μg |
| PlaceboPlacebo (matching indacaterol) was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device. | Drug | Indacaterol 150 μg-tiotropium 18 μg-placebo, Placebo-indacaterol 150 μg-tiotropium 18 μg, Tiotropium 18 μg-placebo-indacaterol 150 μg |
Primary outcome
Peak Inspiratory Capacity Assessed With Spirometry in the 4 Hours After Treatment
Time frame: 4 hour period following inhalation of study treatment
During the 4 hours following inhalation of the study treatment, inspiratory capacity (IC) was measured with spirometry conducted according to internationally accepted standards. IC was measured 3 times each at 30, 60, 120, 180, and 240 minutes post-dose and the highest value was reported in liters.
2 secondary outcomes
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment
Time frame: 4 hour period following inhalation of study treatment
Force Vital Capacity (FVC) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment
Time frame: 4 hour period following inhalation of study treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22035851Rossi A, Centanni S, Cerveri I, Gulotta C, Foresi A, Cazzola M, Brusasco V. Acute effects of indacaterol on lung hyperinflation in moderate COPD: a comparison with tiotropium. Respir Med. 2012 Jan;106(1):84-90. doi: 10.1016/j.rmed.2011.09.006. Epub 2011 Oct 27.
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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
11 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 150 μg and Tiotropium 18 μg in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 11 sites in Italy.
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 7 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 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Italy. 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 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?
Peak Inspiratory Capacity Assessed With Spirometry in the 4 Hours After Treatment (time frame: 4 hour period following inhalation of study treatment). 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 NCT00999908, 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 Feb 2016.