Chronic Obstructive Pulmonary Disease (COPD)Phase 3NCT00615459

A Crossover Study to Determine the Effect on Lung Function of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control

A Phase 3 study testing Indacaterol and Tiotropium in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis at 20 sites in 7 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

The study compared the 24-hour spirometry profile of indacaterol with that of placebo and with tiotropium as an active control in patients with 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 (COPD)
What is being tested?: Indacaterol and Tiotropium
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 169 participants
Where: 20 sitesin 7 countries
Study dates: Feb 2008to Dec 2008
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 out patients with a diagnosis of chronic obstructive pulmonary disease (COPD) (moderate to severe as classified by the Global initiative for chronic obstructive lung disease (GOLD) Guidelines, 2006) and:
Smoking history of at least 10 pack years (current or previous smokers)
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

Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period
Patients requiring long-term oxygen therapy for chronic hypoxemia
Patients who have had a respiratory tract infection within 6 weeks prior to Visit
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 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, MDI or perform spirometry measurements
Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

20 sites in 7 countries.

Country

City, postcode or hospital

20 sites in 7 countries

Germany5 sites

Novartis Investigator Site
Gauting
Novartis Investigator Site
Großhansdorf
Novartis Investigator Site
Mainz
Novartis Investigator site
Marburg
Novartis Investigator Site
Wiesbaden

Other trials in Germany

Netherlands5 sites

Novartis Investigator Site
Almelo
Novartis Investigator Site
Breda
Novartis Investigator Site
Eindhoven
Novartis Investigator Site
Harderwijk
Novartis Investigator Site
Helmond

Other trials in Netherlands

Spain5 sites

Novartis Investigator Site
A Coruña
Novartis Investigative site
Alicante
Novartis Investigative Site
Cacenes
Novartis Investigative Site
Madrid
Novartis Investigator Site
Ourense

Other trials in Spain

Poland2 sites

Novartis Investigator Site
Katowice
Novartis Investigator Site
Warsaw

Other trials in Poland

Australia1 site

Novartis Investigative site
Camperdown

Other trials in Australia

New Zealand1 site

Novartis Investigator Site
Wellington

Other trials in New Zealand

South Africa1 site

Novartis Investigator Site
Durban

Other trials in South Africa

About this study

Official title: A Phase III, Randomized, Double-blind, Double-dummy, Placebo-controlled, Multicenter, 3-period Incomplete Block, Multidose Crossover Study to Determine the Effect on Lung Function of Indacaterol (150 and 300 μg o.d.) in Patients With Moderate to Severe COPD, Using Tiotropium (18 μg o.d.) as an Active Control

The study compared the 24-hour spirometry profile of indacaterol with that of placebo and with tiotropium as an active control in patients with chronic obstructive pulmonary disease.

Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Being tested: Indacaterol, Tiotropium, Placebo
Keywords: Chronic obstructive pulmonary disease, indacaterol, tiotropium, placebo controlled
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 150 μg or 300 μg, delivered via SDDPI
TiotropiumDrug
Tiotropium 18 μg once daily delivered via inhalation device
PlaceboDrug
Placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium manufacturer's proprietary inhalation device (HandiHaler®)

Study groups in NCT00615459
Study group	Role	What they receive
Sequence 1: Placebo,Tiotropium, Indacaterol 150 μg	Experimental	In period I, placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. In period II, tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via single dose dry powder inhaler (SDDPI). In period III, indacaterol 150 μg once daily delivered via SDDPI and placebo to tiotropium was delivered once daily via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study. Receives: Drug: Indacaterol; Drug: Tiotropium; Drug: Placebo
Sequence 2: Indacaterol 300 μg, Indacaterol 150 μg, Tiotropium	Experimental	In period I,indacaterol 300 μg once daily delivered via single dose dry powder inhaler (SDDPI)and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period II, indacaterol 150 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period III, tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via SDDPI. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study. Receives: Drug: Indacaterol; Drug: Tiotropium
Sequence 3: Indacaterol 150 μg, Indacaterol 300 μg, Placebo	Experimental	In period I, indacaterol 150 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period II, indacaterol 300 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period III, placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study. Receives: Drug: Indacaterol; Drug: Placebo
Sequence 4: Tiotropium, Placebo, Indacaterol 300 μg	Experimental	In period I, tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via SDDPI. In period II, placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. In period III, indacaterol 300 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study. Receives: Drug: Indacaterol; Drug: Tiotropium; Drug: Placebo

What is being measured

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

24-hour Post-dose Trough Forced Expiratory Volume in 1 Second (FEV1) After 14 Days of Treatment
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the mean of FEV1 measurements at 23 h 10 min and 23 h 45 min post Day 14 dose measured on the morning of Day 15 in each treatment period. The model used for analysis contained the (period) baseline FEV1 as covariate. The (period) baseline FEV1 was defined as the value measured before the study drug administration in that treatment period.
Measured: 23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 15 of each treatment period

Secondary outcomes (1)

Peak FEV1 During 4 Hours Post Morning Dose on Day 1
FEV1 was measured with spirometry conducted according to internationally accepted standards. The peak effect on Day 1 was defined as the maximum FEV1 during the first 4 hour on that day. FEV1 measurements taken within 6 hour of rescue use were set to missing before the peak FEV1 (0-4 hour) was calculated. The model used for analysis contained the (period) baseline FEV1 as covariate. The (period) baseline FEV1 was defined as the value measured before the study drug administration in that treatment period.
Measured: Day 1 (from 0 to 4 hours post morning dose)

Timeline

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

Feb 2008Dec 2008

First posted14 Feb 2008 (estimated)
Study startFeb 2008
Primary completionDec 2008
Study completionDec 2008

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.
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: Double blind
Who is masked: Participant, Investigator
Enrolment: 169 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00615459
Sponsor's protocol ID: CQAB149B2331
Status last verified: Jul 2011
First submitted: 1 Feb 2008
Last updated: 17 Aug 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Vogelmeier C, Ramos-Barbon D, Jack D, Piggott S, Owen R, Higgins M, Kramer B; INTIME study investigators (INdacaterol & TIotropium: Measuring Efficacy). Indacaterol provides 24-hour bronchodilation in COPD: a placebo-controlled blinded comparison with tiotropium. Respir Res. 2010 Oct 5;11(1):135. doi: 10.1186/1465-9921-11-135.
PubMed 20920365

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 Phase III, Randomized, Double-blind, Double-dummy, Placebo-controlled, Multicenter, 3-period Incomplete Block, Multidose Crossover Study to Determine the Effect on Lung Function of Indacaterol (150 and 300 μg o.d.) in Patients With Moderate to Severe COPD, Using Tiotropium (18 μg o.d.) as an Active Control
ClinicalTrials.gov ID: NCT00615459
Acronym / sponsor ID: CQAB149B2331
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic obstructive pulmonary disease, indacaterol, tiotropium, placebo controlled
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 169 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Study start: Feb 2008
Primary completion: Dec 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 14 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.

The study compared the 24-hour spirometry profile of indacaterol with that of placebo and with tiotropium as an active control in patients with chronic obstructive pulmonary disease.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Sequence 1: Placebo,Tiotropium, Indacaterol 150 μg	Experimental	Drug: Indacaterol, Drug: Tiotropium, Drug: PlaceboIn period I, placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. In period II, tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via single dose dry powder inhaler (SDDPI). In period III, indacaterol 150 μg once daily delivered via SDDPI and placebo to tiotropium was delivered once daily via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
Sequence 2: Indacaterol 300 μg, Indacaterol 150 μg, Tiotropium	Experimental	Drug: Indacaterol, Drug: TiotropiumIn period I,indacaterol 300 μg once daily delivered via single dose dry powder inhaler (SDDPI)and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period II, indacaterol 150 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period III, tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via SDDPI. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.
Sequence 3: Indacaterol 150 μg, Indacaterol 300 μg, Placebo	Experimental	Drug: Indacaterol, Drug: PlaceboIn period I, indacaterol 150 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period II, indacaterol 300 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period III, placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.
Sequence 4: Tiotropium, Placebo, Indacaterol 300 μg	Experimental	Drug: Indacaterol, Drug: Tiotropium, Drug: PlaceboIn period I, tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via SDDPI. In period II, placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. In period III, indacaterol 300 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA 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 out patients with a diagnosis of chronic obstructive pulmonary disease (COPD) (moderate to severe as classified by the Global initiative for chronic obstructive lung disease (GOLD) Guidelines, 2006) and:

Key exclusion criteria (12 listed)

Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period
Patients requiring long-term oxygen therapy for chronic hypoxemia
Patients who have had a respiratory tract infection within 6 weeks prior to Visit
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
IndacaterolIndacaterol 150 μg or 300 μg, delivered via SDDPI	Drug	Sequence 1: Placebo,Tiotropium, Indacaterol 150 μg, Sequence 2: Indacaterol 300 μg, Indacaterol 150 μg, Tiotropium, Sequence 3: Indacaterol 150 μg, Indacaterol 300 μg, Placebo, Sequence 4: Tiotropium, Placebo, Indacaterol 300 μg
TiotropiumTiotropium 18 μg once daily delivered via inhalation device	Drug	Sequence 1: Placebo,Tiotropium, Indacaterol 150 μg, Sequence 2: Indacaterol 300 μg, Indacaterol 150 μg, Tiotropium, Sequence 4: Tiotropium, Placebo, Indacaterol 300 μg
PlaceboPlacebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium manufacturer's proprietary inhalation device (HandiHaler®)	Drug	Sequence 1: Placebo,Tiotropium, Indacaterol 150 μg, Sequence 3: Indacaterol 150 μg, Indacaterol 300 μg, Placebo, Sequence 4: Tiotropium, Placebo, Indacaterol 300 μg

Primary outcome

24-hour Post-dose Trough Forced Expiratory Volume in 1 Second (FEV1) After 14 Days of Treatment
Time frame: 23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 15 of each treatment period
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the mean of FEV1 measurements at 23 h 10 min and 23 h 45 min post Day 14 dose measured on the morning of Day 15 in each treatment period. The model used for analysis contained the (period) baseline FEV1 as covariate. The (period) baseline FEV1 was defined as the value measured before the study drug administration in that treatment period.

1 secondary outcome

Peak FEV1 During 4 Hours Post Morning Dose on Day 1
Time frame: Day 1 (from 0 to 4 hours post morning dose)

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
Sequence 1: Placebo,Tiotropium, Indacaterol 150 μg	41	37
Sequence 2: Indacaterol 300 μg, Indacaterol 150 μg, Tiotropium	41	40
Sequence 3: Indacaterol 150 μg, Indacaterol 300 μg, Placebo	42	40
Sequence 4: Tiotropium, Placebo, Indacaterol 300 μg	43	42

Primary outcome: 24-hour Post-dose Trough Forced Expiratory Volume in 1 Second (FEV1) After 14 Days of Treatment

Time frame: 23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 15 of each treatment period. Least squares mean (Standard Error). Unit: Liters

Measure	Indacaterol 150 μg n = 116	Indacaterol 300 μg n = 119	Tiotropium 18 μg n = 112	Placebo n = 118
Value	1.53 (0.021)	1.51 (0.021)	1.48 (0.021)	1.36 (0.021)

Population analysed: The modified intent-to-treat (mITT) population, included all randomized patients who received at least one dose of study drug. Patients were analyzed according to treatment they received.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 10 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Indacaterol 150 μg	2 of 118 (1.7%)	15 of 118 (12.7%)	Not reported
Indacaterol 300 μg	1 of 122 (0.8%)	17 of 122 (13.9%)	Not reported
Tiotropium 18 μg	4 of 120 (3.3%)	11 of 120 (9.2%)	Not reported
Placebo	1 of 123 (0.8%)	13 of 123 (10.6%)	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 20920365Vogelmeier C, Ramos-Barbon D, Jack D, Piggott S, Owen R, Higgins M, Kramer B; INTIME study investigators (INdacaterol & TIotropium: Measuring Efficacy). Indacaterol provides 24-hour bronchodilation in COPD: a placebo-controlled blinded comparison with tiotropium. Respir Res. 2010 Oct 5;11(1):135. doi: 10.1186/1465-9921-11-135.

Related trials for Chronic Obstructive Pulmonary Disease (COPD)

RecruitingPhase 2
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RecruitingPhase 2
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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 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Indacaterol and Tiotropium in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis at 20 sites in 7 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 20 sites in Germany, Netherlands, Spain, Poland, Australia and 2 more countries. 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?

24-hour Post-dose Trough Forced Expiratory Volume in 1 Second (FEV1) After 14 Days of Treatment (time frame: 23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 15 of each treatment period). 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 NCT00615459, 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.