AsthmaPhase 3NCT01079130

Efficacy and Safety of Different Doses of Indacaterol

A Phase 3 study testing Indacaterol and Salmeterol in people with Asthma, run by Novartis Pharmaceuticals at 71 sites in United States.

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 compared the 14-day bronchodilator efficacy of indacaterol with that of placebo and salmeterol Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Asthma
What is being tested?: Indacaterol and Salmeterol
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 511 participants
Where: 71 sitesUnited States
Study dates: Feb 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 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
Prebronchodilator forced expiratory volume in 1 second (FEV1) at screening ≥50 and ≤90% of predicted normal
An increase of ≥12% and ≥200 mL in FEV1 over prebronchodilator value within 30 minutes after inhaling albuterol

Who cannot join

Smoking history >10 pack-years
Patients with a diagnosis of chronic obstructive pulmonary disease (COPD)
Patients with seasonal allergy whose asthma is likely to deteriorate during the study period
Patients who have experienced a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to screening
Patients who have had an intubation for a severe asthma exacerbation
Patients who have had an emergency room visit for an asthma attack/asthma exacerbation within 6 weeks prior to screening

Show all 13Show fewer

Patients who have had a respiratory tract infection within 6 weeks prior to screening
Patients with concomitant pulmonary disease
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
Patients who have ever received or are currently receiving omalizumab or chronic oral corticosteroid therapy
Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

71 sites in 1 country.

City, postcode or hospital

71 sites in 1 country

United States71 sites

Novartis Investigator Site
Austin, Texas, 78758
Novartis Investigative Site
Baltimore, Maryland, 21236
Novartis Investigator Site
Bellevue, Nebraska, 68123
Novartis Investigator Site
Boise, Idaho, 83704
Novartis Investigator Site
Boys Town, Nebraska, 68010
Novartis Investigator Site
Cadiz, Ohio, 43907
Novartis Investigative Site
Charleston, South Carolina, 29414
Novartis Investigative Site
Charlotte, North Carolina, 28207
Novartis Investigator Site
Colorado Springs, Colorado, 80907
Novartis Investigator Site
Columbia, Maryland, 21044
Novartis Investigator Site
Columbia, Missouri, 65203
Novartis Investigative Site
Columbus, Ohio, 43215
Novartis Investigator Site
Dallas, Texas, 75231
Novartis Investigator Site
Denver, Colorado, 80230
Novartis Investigative site
Destin, Florida, 32541
Novartis Investigator Site
El Paso, Texas, 79903
Novartis Investigator Site
El Paso, Texas, 79925
Novartis Investigator Site
Encinitas, California, 92024
Novartis Investigator Site
Engelwood, Colorado, 80112
Novartis Investigative Site
Erie, Pennsylvania, 16506
Novartis Investigator Site
Georgetown, Texas, 78628
Novartis Investigator Site
Glendale, Arizona, 85306
Novartis Investigator Site
Huntington Beach, California, 92647
Novartis Investigator Site
Lafayette, Louisiana, 70503
Novartis Investigator Site
Lake Oswego, Oregon, 97035
Novartis Investigator Site
Lakewood, Colorado, 80401
Novartis Investigative Site
Lincoln, Rhode Island, 02865
Novartis Investigator Site
Los Angeles, California, 90025
Novartis Investigator Site
Los Angeles, California, 90048
Novartis Investigative Site
Louisville, Kentucky, 40215
Novartis Investigative Site
Maumee, Ohio, 43537
Novartis Investigative Site
Medford, Oregon, 97504
Novartis Investigative Site
Minneapolis, Minnesota, 55402
Novartis Investigative Site
Mission Viejo, California, 92691
Novartis Investigative Site
Missoula, Montana, 59808
Novartis Investigator Site
Normal, Illinois, 61761
Novartis Investigative site
North Charleston, South Carolina, 29406
Novartis Investigative Site
North Dartmouth, Massachusetts, 02747
Novartis Investigator Site
North Richland Hills, Texas, 76180
Novartis Investigative Site
Ocean City, New Jersey, 07712
Novartis Investigator Site
Oklahoma City, Oklahoma, 73103
Novartis Investigator Site
Orange, California, 92868
Novartis Investigator Site
Overland Park, Kansas, 66210
Novartis Investigative Site
Pensacola, Florida, 32503
Novartis Investigative Site
Pensacola, Florida, 32514
Novartis Investigative Site
Phoenixville, Pennsylvania, 19460
Novartis Investigative Site
Pittsburgh, Pennsylvania, 15243
Novartis Investigative Site
Port Orange, Florida, 32127
Novartis Investigator Site
Portland, Oregon, 97213
Novartis Investigative Site
Raleigh, North Carolina, 27607
Novartis Investigator Site
Rancho Mirage, California, 92270
Novartis Investigator Site
Rolla, Missouri, 65401
Novartis Investigator Site
Rolling Hills Estates, California, 90274
Novartis Investigator Site
San Diego, California, 92120
Novartis Investigator Site
San Diego, California, 92123
Novartis Investigator Site
San Jose, California, 95117
Novartis Investigative Site
Sarasota, Florida, 34233
Novartis Investigator Site
Scottsdale, Arizona, 85251
Novartis Investigator Site
Seattle, Washington, 98105
Novartis Investigative Site
Skillman, New Jersey, 08558
Novartis Investigative Site
Springfield, Illinois, 62703
Novartis Investigator Site
St Louis, Missouri, 63141
Novartis Investigative Site
Stamford, Connecticut, 06902
Novartis Investigator Site
Stockton, California, 95207
Novartis Investigative Site
Tamarac, Florida, 33321
Novartis Investigative Site
Upland, Pennsylvania, 19013
Novartis Investigator Site
Waco, Texas, 73712
Novartis Investigator Site
Warrensburg, Missouri, 64093
Novartis Investigative Site
Waterbury, Connecticut, 06708
Novartis Investigative Site
Wheaton, Maryland, 20902
Novartis Investigative Site
Winter Park, Florida, 32789

Other trials in United States

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 Adult Patients With Persistent Asthma, Using Salmeterol as an Active Control

This study compared the 14-day bronchodilator efficacy of indacaterol with that of placebo and salmeterol

Conditions: Asthma
Being tested: Indacaterol, Salmeterol, Placebo to Indacaterol, Placebo to Salmeterol
Keywords: Indacaterol, asthma, salmeterol
Medical subject headings: Asthma

What participants receive

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

IndacaterolDrug
Once daily via Concept1, a single-dose dry powder inhaler (SDDPI) for two week. Dosage varies according to randomization scheme.
SalmeterolDrug
50 µg Salmeterol twice daily in the morning and in the evening via Diskus®, a MDDPI for 2 weeks.
Placebo to IndacaterolDrug
Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI.
Placebo to SalmeterolDrug
Placebo to Salmeterol twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI).

Study groups in NCT01079130
Study group	Role	What they receive
Indacaterol 18.75 µg	Experimental	Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. Receives: Drug: Indacaterol; Drug: Placebo to Salmeterol
Indacaterol 37.5 µg	Experimental	Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. Receives: Drug: Indacaterol; Drug: Placebo to Salmeterol
Indacaterol 75 µg	Experimental	Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. Receives: Drug: Indacaterol; Drug: Placebo to Salmeterol
Indacaterol 150 µg	Experimental	Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. Receives: Drug: Indacaterol; Drug: Placebo to Salmeterol
Salmeterol	Active comparator	Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. Receives: Drug: Salmeterol; Drug: Placebo to Indacaterol
Placebo	Placebo comparator	Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol 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) After 2 Weeks of Treatment
Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose. The mixed model used baseline FEV1 and FEV1 prior to and 30 minutes post inhalation of albuterol as covariates.
Measured: Day 15 (after 2 weeks of treatment)

Secondary outcomes (1)

Trough Forced Expiratory Volume in 1 Second (FEV1) After 1 Day of Treatment
Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose on day 2. The mixed model used baseline FEV1 and FEV1 prior to and 30 minutes post inhalation of albuterol as covariates.
Measured: Day 2 (after 1 day of treatment)

Timeline

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

Feb 2010Jul 2010

First posted2 Mar 2010 (estimated)
Study startFeb 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 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 511 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01079130
Sponsor's protocol ID: CQAB149B2357
Status last verified: Jul 2011
First submitted: 1 Mar 2010
Last updated: 19 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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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 Adult Patients With Persistent Asthma, Using Salmeterol as an Active Control
ClinicalTrials.gov ID: NCT01079130
Acronym / sponsor ID: CQAB149B2357
Conditions: Asthma
Keywords: Indacaterol, asthma, salmeterol
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 511 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Feb 2010
Primary completion: Jul 2010 (actual)
First posted: 2 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 SalmeterolIndacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
Indacaterol 37.5 µg	Experimental	Drug: Indacaterol, Drug: Placebo to SalmeterolIndacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
Indacaterol 75 µg	Experimental	Drug: Indacaterol, Drug: Placebo to SalmeterolIndacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
Indacaterol 150 µg	Experimental	Drug: Indacaterol, Drug: Placebo to SalmeterolIndacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
Salmeterol	Active comparator	Drug: Salmeterol, Drug: Placebo to IndacaterolSalmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
Placebo	Placebo comparator	Drug: Placebo to Indacaterol, Drug: Placebo to SalmeterolPlacebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) 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:

Key exclusion criteria (13 listed)

Smoking history >10 pack-years
Patients with a diagnosis of chronic obstructive pulmonary disease (COPD)
Patients with seasonal allergy whose asthma is likely to deteriorate during the study period
Patients who have experienced a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to screening
Patients who have had an intubation for a severe asthma exacerbation

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
IndacaterolOnce daily via Concept1, a single-dose dry powder inhaler (SDDPI) for two week. Dosage varies according to randomization scheme.	Drug	Indacaterol 150 µg, Indacaterol 18.75 µg, Indacaterol 37.5 µg, Indacaterol 75 µg
Salmeterol50 µg Salmeterol twice daily in the morning and in the evening via Diskus®, a MDDPI for 2 weeks.	Drug	Salmeterol
Placebo to IndacaterolPlacebo to Indacaterol once daily in the morning via Concept 1, a SDDPI.	Drug	Placebo, Salmeterol
Placebo to SalmeterolPlacebo to Salmeterol twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI).	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) After 2 Weeks of Treatment
Time frame: Day 15 (after 2 weeks of treatment)
Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose. The mixed model used baseline FEV1 and FEV1 prior to and 30 minutes post inhalation of albuterol as covariates.

1 secondary outcome

Trough Forced Expiratory Volume in 1 Second (FEV1) After 1 Day of Treatment
Time frame: Day 2 (after 1 day of treatment)

Results and safety

Results posted to the registry on 19 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 18.75 µg	85	83
Indacaterol 37.5 µg	85	78
Indacaterol 75 µg	84	83
Indacaterol 150 µg	86	81
Salmeterol	86	78
Placebo	85	80

Primary outcome: Trough Forced Expiratory Volume in 1 Second (FEV1) After 2 Weeks of Treatment

Time frame: Day 15 (after 2 weeks of treatment). Least squares mean (Standard Error). Unit: Liters

Measure	Indacaterol 18.75 µg n = 82	Indacaterol 37.5 µg n = 77	Indacaterol 75 µg n = 82	Indacaterol 150 µg n = 80	Salmeterol n = 78	Placebo n = 81
Value	2.50 (0.036)	2.52 (0.037)	2.59 (0.036)	2.54 (0.037)	2.54 (0.037)	2.42 (0.036)

Population analysed: Participants from the Full Analysis Set, randomized participants who received at least one dose of study drug, who had efficacy data for this outcome measure. Missing data were imputed last observation carried forward (LOCF).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 2 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Indacaterol 18.75 µg	0 of 84 (0%)	4 of 84 (4.8%)	Not reported
Indacaterol 37.5 µg	0 of 81 (0%)	2 of 81 (2.5%)	Not reported
Indacaterol 75 µg	0 of 84 (0%)	12 of 84 (14.3%)	Not reported
Indacaterol 150 µg	1 of 85 (1.2%)	7 of 85 (8.2%)	Not reported
Salmeterol	0 of 84 (0%)	5 of 84 (6%)	Not reported
Placebo	0 of 84 (0%)	4 of 84 (4.8%)	Not reported

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

71 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 in people with Asthma, run by Novartis Pharmaceuticals at 71 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 13 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 71 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) After 2 Weeks of Treatment (time frame: Day 15 (after 2 weeks of 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 NCT01079130.

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.