Persistent AsthmaPhase 2NCT01156844

Efficacy, Safety and Pharmacokinetics of Different Regimens of Indacaterol

A Phase 2 study testing Indacaterol in people with Persistent Asthma, run by Novartis Pharmaceuticals at 30 sites in 6 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

This study assessed the bronchodilator efficacy of three different regimens of indacaterol in patients with asthma Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Persistent Asthma
What is being tested?: Indacaterol
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 191 participants
Where: 30 sitesin 6 countries
Study dates: Mar 2010to Jul 2010
Phase: Phase 2
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with a diagnosis of asthma and:
Receiving daily treatment with inhaled corticosteroid in a regimen that has been stable for at least a month prior to screening
FEV1 ≥50% and ≤90% of predicted normal at screening
An increase of ≥12% and ≥200 mL in FEV1 over prebronchodilator value within 30 minutes after inhaling a total dose of albuterol/salbutamol of 360/400 MDI

Who cannot join

Smoking history of ≥ 10 years
Patients with a diagnosis of COPD
Patients who have been previously intubated for a severe asthma exacerbation/ attack
Patients who have experienced a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to screening
Patients who have had an emergency room visit for an asthma attack/exacerbation within 6 weeks prior to screening
Patients who have had a respiratory tract infection within 6 weeks prior to screening

Show all 9Show fewer

Patients with seasonal allergy whose asthma is likely to deteriorate during the study period
Patients with Type I or uncontrolled Type II diabetes mellitus
Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

30 sites in 6 countries.

Country

City, postcode or hospital

30 sites in 6 countries

United States21 sites

Novartis Investigative Site
Anniston, Alabama, 36207
Novartis Investigative Site
Berlin, New Jersey, 08009
Novartis Investigative Site
Clearwater, Florida, 33756
Novartis Investigative Site
Cypress, California, 90630
Novartis Investigative Site
Denver, Colorado, 80206
Novartis Investigative Site
Fresno, California, 93726
Novartis Investigative Site
Houston, Texas, 77070
Novartis Investigative Site
Lafayette, Louisiana, 70503
Novartis Investigative Site
Las Vegas, Nevada, 89119
Novartis Investigative Site
Miami, Florida, 33167
Novartis Investigative Site
Miami, Florida, 33175
Novartis Investigative Site
Normal, Illinois, 61761
Novartis Investigator Site
Oklahoma City, Oklahoma, 73120
Novartis Investigative Site
Plano, Texas, 75075
Novartis Investigative Site
Raleigh, North Carolina, 27607
Novartis Investigative Site
San Antonio, Texas, 78212
Novartis Investigative Site
San Diego, California, 92120
Novartis Investigative Site
Sarasota, Florida, 34233
Novartis Investigative Site
Tacoma, Washington, 98405
Novartis Investigative Site
Tacoma, Washington, 98418
Novartis Investigative Site
Tampa, Florida, 33617

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United Kingdom3 sites

Novartis Investigative Site
London
Novartis Investigative Site
Manchester
Novartis Investigative Site
Merthyr Tydfil

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France2 sites

Novartis Investigative Site
Paris
Novartis Investigative Site
Rennes

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Jordan2 sites

Novartis Investigative Site
Amman
Novartis Investigative Site
Irbid

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Germany1 site

Novartis Investigative Site
Wiesbaden

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Netherlands1 site

Novartis Investigative Site
Groningen

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About this study

Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Repeated-dose Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Three Different Dosing Regimens of Inhaled Indacaterol Maleate in Patients With Persistent Asthma

This study assessed the bronchodilator efficacy of three different regimens of indacaterol in patients with asthma

Conditions: Persistent Asthma
Being tested: Indacaterol, Placebo to Indacaterol
Keywords: Indacaterol, Asthma, Bronchodilation, Beta-agonist
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IndacaterolDrug
Indacaterol inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for 16 days. Dosage and frequency varied according to randomization scheme.
Placebo to IndacaterolDrug
Placebo inhaled via Concept1, a SDDPI. Frequency varied according to randomization scheme.

Study groups in NCT01156844
Study group	Role	What they receive
Indacaterol 37.5 µg (twice a day)	Experimental	Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. Receives: Drug: Indacaterol
Indacaterol 75 µg (once a day)	Experimental	Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. Receives: Drug: Indacaterol; Drug: Placebo to Indacaterol
Indacaterol 150 µg (every other day)	Experimental	Indacaterol 150 µg every other day (qod) inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for a total of 16 days. Indacaterol 150 µg inhaled via Concept1, a SDDPI, in the morning and Placebo to Indacaterol inhaled via Concept1 in the evening on odd days; and Placebo to Indacaterol inhaled via Concept1 in the morning and in the evening on even days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. Receives: Drug: Indacaterol; Drug: Placebo to Indacaterol
Placebo	Placebo comparator	Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) 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.

Change From Baseline in the Trough Forced Expiratory Volume in One Second (FEV1) After Two Weeks of Treatment
Spirometry was conducted according to internationally accepted standards. Trough FEV1 values were calculated as the mean of the 23.17 hours and 23.75 hours post morning dose FEV1 measurements. Analysis of covariance model was used with baseline FEV1 as a continuous covariate.
Measured: Baseline to week 2
Change From Baseline in the Forced Expiratory Volume in 1 Second Standardized (With Respect to Time) Area Under the Curve (AUC) From 0 to 24 Hours Post Dose (FEV1 AUC 0-24h) After Two Weeks of Treatment
Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC 0-24 hours) of FEV1 measurements taken at pre-dose to 24 hours post-dose was calculated based on the trapezoidal rule and was adjusted for the area per time unit using the scheduled time of measurements for FEV1. Analysis of covariance model was used with baseline FEV1 as a continuous covariate.
Measured: Baseline, 0-24 hours post dose week 2
Change From Baseline in the Forced Expiratory Volume in 1 Second Standardized (With Respect to Time) Area Under the Curve (AUC) From 0 to 48 Hours (FEV1 AUC 0-48h) After Two Weeks of Treatment
Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC 0-48 hours) of FEV1 measurements taken at pre-dose to 48 hours post-dose was calculated based on the trapezoidal rule and was adjusted for the area per time unit by using the scheduled time of measurements for FEV1. Analysis of covariance model was used with baseline FEV1 as a continuous covariate.
Measured: Baseline, 0 to 48 hours post dose week 2

Secondary outcomes (1)

Change From Baseline in the Forced Expiratory Volume in 1 Second Standardized (With Respect to Time) Area Under the Curve (AUC) From 0 to 12 Hours (FEV1 AUC 0-12h) After Two Weeks of Treatment
Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC 0-12 hours) of FEV1 measurements taken at pre-dose to 12 hours post-dose was calculated based on the trapezoidal rule and was adjusted for the area per time unit by using the scheduled time of measurements for FEV1. Analysis of covariance model was used with baseline FEV1 as a continuous covariate.
Measured: Baseline, 0 to 12 hours post dose week 2

Timeline

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

Mar 2010Jul 2010

First posted5 Jul 2010 (estimated)
Study startMar 2010
Primary 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 Persistent AsthmaStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 191 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01156844
Sponsor's protocol ID: CQAB149B2223
Other IDs: 2010-018481-22
Status last verified: Jul 2011
First submitted: 30 Jun 2010
Last updated: 17 Aug 2011
Results posted: Yes, on ClinicalTrials.gov

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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All Persistent Asthma trials

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 Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Repeated-dose Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Three Different Dosing Regimens of Inhaled Indacaterol Maleate in Patients With Persistent Asthma
ClinicalTrials.gov ID: NCT01156844
Acronym / sponsor ID: CQAB149B2223
Conditions: Persistent Asthma
Keywords: Indacaterol, Asthma, Bronchodilation, Beta-agonist
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 191 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Mar 2010
Primary completion: Jul 2010 (actual)
First posted: 5 Jul 2010 (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 assessed the bronchodilator efficacy of three different regimens of indacaterol in patients with asthma

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Indacaterol 37.5 µg (twice a day)	Experimental	Drug: IndacaterolIndacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Indacaterol 75 µg (once a day)	Experimental	Drug: Indacaterol, Drug: Placebo to IndacaterolIndacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Indacaterol 150 µg (every other day)	Experimental	Drug: Indacaterol, Drug: Placebo to IndacaterolIndacaterol 150 µg every other day (qod) inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for a total of 16 days. Indacaterol 150 µg inhaled via Concept1, a SDDPI, in the morning and Placebo to Indacaterol inhaled via Concept1 in the evening on odd days; and Placebo to Indacaterol inhaled via Concept1 in the morning and in the evening on even days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Placebo	Placebo comparator	Drug: Placebo to IndacaterolPlacebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients with a diagnosis of asthma and:
Receiving daily treatment with inhaled corticosteroid in a regimen that has been stable for at least a month prior to screening
FEV1 ≥50% and ≤90% of predicted normal at screening
An increase of ≥12% and ≥200 mL in FEV1 over prebronchodilator value within 30 minutes after inhaling a total dose of albuterol/salbutamol of 360/400 MDI

Key exclusion criteria (9 listed)

Smoking history of ≥ 10 years
Patients with a diagnosis of COPD
Patients who have been previously intubated for a severe asthma exacerbation/ attack
Patients who have experienced a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to screening
Patients who have had an emergency room visit for an asthma attack/exacerbation within 6 weeks prior to 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
IndacaterolIndacaterol inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for 16 days. Dosage and frequency varied according to randomization scheme.	Drug	Indacaterol 150 µg (every other day), Indacaterol 37.5 µg (twice a day), Indacaterol 75 µg (once a day)
Placebo to IndacaterolPlacebo inhaled via Concept1, a SDDPI. Frequency varied according to randomization scheme.	Drug	Indacaterol 150 µg (every other day), Indacaterol 75 µg (once a day), Placebo

Primary outcome

Change From Baseline in the Trough Forced Expiratory Volume in One Second (FEV1) After Two Weeks of Treatment
Time frame: Baseline to week 2
Spirometry was conducted according to internationally accepted standards. Trough FEV1 values were calculated as the mean of the 23.17 hours and 23.75 hours post morning dose FEV1 measurements. Analysis of covariance model was used with baseline FEV1 as a continuous covariate.
Change From Baseline in the Forced Expiratory Volume in 1 Second Standardized (With Respect to Time) Area Under the Curve (AUC) From 0 to 24 Hours Post Dose (FEV1 AUC 0-24h) After Two Weeks of Treatment
Time frame: Baseline, 0-24 hours post dose week 2
Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC 0-24 hours) of FEV1 measurements taken at pre-dose to 24 hours post-dose was calculated based on the trapezoidal rule and was adjusted for the area per time unit using the scheduled time of measurements for FEV1. Analysis of covariance model was used with baseline FEV1 as a continuous covariate.
Change From Baseline in the Forced Expiratory Volume in 1 Second Standardized (With Respect to Time) Area Under the Curve (AUC) From 0 to 48 Hours (FEV1 AUC 0-48h) After Two Weeks of Treatment
Time frame: Baseline, 0 to 48 hours post dose week 2
Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC 0-48 hours) of FEV1 measurements taken at pre-dose to 48 hours post-dose was calculated based on the trapezoidal rule and was adjusted for the area per time unit by using the scheduled time of measurements for FEV1. Analysis of covariance model was used with baseline FEV1 as a continuous covariate.

1 secondary outcome

Change From Baseline in the Forced Expiratory Volume in 1 Second Standardized (With Respect to Time) Area Under the Curve (AUC) From 0 to 12 Hours (FEV1 AUC 0-12h) After Two Weeks of Treatment
Time frame: Baseline, 0 to 12 hours post dose week 2

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
Indacaterol 37.5 µg (Twice a Day)	48	46
Indacaterol 75 µg (Once a Day)	48	46
Indacaterol 150 µg (Every Other Day)	48	42
Placebo	47	41

Primary outcome: Change From Baseline in the Trough Forced Expiratory Volume in One Second (FEV1) After Two Weeks of Treatment

Time frame: Baseline to week 2. Least squares mean (90% Confidence Interval). Unit: Liters

Measure	Indacaterol 37.5 µg (Twice a Day) n = 48	Indacaterol 75 µg (Once a Day) n = 47	Indacaterol 150 µg (Every Other Day) n = 48	Placebo n = 46
Value	0.156 (0.083 to 0.228)	0.197 (0.125 to 0.269)	0.199 (0.125 to 0.272)	-0.005 (-0.080 to 0.071)

Population analysed: Pharmacodynamic (PD) Analysis Set included all randomized participants who received at least one dose of study drug and who had evaluable PD data.

Primary outcome: Change From Baseline in the Forced Expiratory Volume in 1 Second Standardized (With Respect to Time) Area Under the Curve (AUC) From 0 to 24 Hours Post Dose (FEV1 AUC 0-24h) After Two Weeks of Treatment

Time frame: Baseline, 0-24 hours post dose week 2. Least squares mean (90% Confidence Interval). Unit: Liters

Measure	Indacaterol 37.5 µg (Twice a Day) n = 48	Indacaterol 75 µg (Once a Day) n = 47	Placebo n = 46
Value	0.196 (0.127 to 0.266)	0.198 (0.127 to 0.269)	0.030 (-0.044 to 0.103)

Population analysed: Pharmacodynamic (PD) Analysis Set included all randomized participants who received at least one dose of study drug and who had evaluable PD data.

Primary outcome: Change From Baseline in the Forced Expiratory Volume in 1 Second Standardized (With Respect to Time) Area Under the Curve (AUC) From 0 to 48 Hours (FEV1 AUC 0-48h) After Two Weeks of Treatment

Time frame: Baseline, 0 to 48 hours post dose week 2. Least squares mean (90% Confidence Interval). Unit: Liters

Measure	Indacaterol 75 µg (Once a Day) n = 47	Indacaterol 150 µg (Every Other Day) n = 48	Placebo n = 46
Value	0.218 (0.148 to 0.288)	0.198 (0.135 to 0.260)	0.059 (-0.012 to 0.129)

Population analysed: Pharmacodynamic (PD) Analysis Set included all randomized participants who received at least one dose of study drug and who had evaluable PD data.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Indacaterol 37.5 ug (Twice a Day)	0 of 48 (0%)	7 of 48 (14.6%)	Not reported
Indacaterol 75 ug (Once a Day)	0 of 47 (0%)	8 of 47 (17%)	Not reported
Indacaterol 150 ug (Every Other Day)	1 of 48 (2.1%)	11 of 48 (22.9%)	Not reported
Placebo	0 of 46 (0%)	8 of 46 (17.4%)	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.

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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

30 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Indacaterol in people with Persistent Asthma, run by Novartis Pharmaceuticals at 30 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 4 inclusion and 9 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 30 sites in United States, United Kingdom, France, Jordan, Germany 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Change From Baseline in the Trough Forced Expiratory Volume in One Second (FEV1) After Two Weeks of Treatment (time frame: Baseline to week 2). The study lists 3 primary outcomes in all. 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 NCT01156844.

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.