AsthmaPhase 2QAB149NCT01959412

Crossover Study to Evaluate the Efficacy, Safety and Tolerability of Different Doses of Indacaterol in Patients With Persistent Asthma

A Phase 2 study testing Indacaterol 27.5 mcg, Indacaterol 37.5 and Indacaterol 55 mcg in people with Asthma, run by Novartis Pharmaceuticals at 12 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

The purpose of this study is to determine the efficacy of indacaterol 55µg once daily (and 27.5 µg twice) in QVA149 compared to 75 µg indacaterol monotherapy. 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 27.5 mcg, Indacaterol 37.5 and Indacaterol 55 mcg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 91 participants
Where: 12 sitesUnited States
Study dates: Nov 2013to Mar 2014
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

Asthma for at least 6 months, using inhaled corticosteroid for at least one month, foreced breath test less than below the normal value of the general population, -show an immediate improvement in breathing when given albuterol

Who cannot join

patients who have smoked in the past 6 months or are currently smoking, including those who smoked more than a pack of cigarettes a day for at least 10 years, -patients who have a history of life-threatening asthma, -patients who have had an astham attack, in the last 6 weeks, requiring use of systemic steroids, hospitalization, or ER visit, -patients who have had a respiratory tract infection or worsening asthma between screening or run-in periods, patients requring use of other asthma-related drugs during the trial, other protocol-defined inclusion/exclusion may apply

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

Novartis Investigative Site
Centennial, Colorado, 80112
Novartis Investigative Site
Dallas, Texas, 75231
Novartis Investigative Site
El Paso, Texas, 79902
Novartis Investigative Site
Huntington Beach, California, 92647
Novartis Investigative Site
Los Angeles, California, 90048
Novartis Investigative Site
Medford, Oregon, 97504-8741
Novartis Investigative Site
Mission Viejo, California, 92691
Novartis Investigative Site
North Dartmouth, Massachusetts, 02747
Novartis Investigative Site
Portland, Oregon, 97213
Novartis Investigative Site
Raleigh, North Carolina, 27607
Novartis Investigative Site
Skillman, New Jersey, 08558
Novartis Investigative Site
St Louis, Missouri, 63141

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Efficacy, Safety and Tolerability of Five Different Doses of Inhaled Indacaterol (QAB149) Delivered Via the Single Dose Dry Powder Inhaler (SDDPI) in Patients With Persistent Asthma

The purpose of this study is to determine the efficacy of indacaterol 55µg once daily (and 27.5 µg twice) in QVA149 compared to 75 µg indacaterol monotherapy.

Conditions: Asthma
Being tested: Indacaterol 27.5 mcg, Indacaterol 37.5, Indacaterol 55 mcg, Indacaterol 75 mcg, Indacaterol 150 mcg
Keywords: wheezing, short of breath, laba, inhaler
Medical subject headings: Asthma, Respiratory Sounds, Dyspnea

What participants receive

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

Indacaterol 27.5 mcgDrug
indacaterol 27.5 mcg twice daily inhaled once via inhaler
Indacaterol 37.5Drug
Indacaterol 37.5 mcg once daily, inhaled once via inhaler
Indacaterol 55 mcgDrug
Indacaterol 55 mcg once daily, inhaled once via inhaler
Indacaterol 75 mcgDrug
Indacaterol 75 mcg once daily, inhaled once via inhaler
Indacaterol 150 mcgDrug
Indacaterol 150 mcg once daily, inhaled once via inhaler
PlaceboDrug
Placebo to indacaterol once or twice daily (depending on assigned sequence) via inlaher

Study groups in NCT01959412
Study group	Role	What they receive
Treatment Period Sequence 1	Experimental	Indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening Receives: Drug: Indacaterol 27.5 mcg; Drug: Placebo
Treatment Period Sequence 2	Experimental	Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening Receives: Drug: Indacaterol 37.5; Drug: Placebo
Treatment Period Sequence 3	Experimental	Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening Receives: Drug: Indacaterol 55 mcg; Drug: Placebo
Treatment Sequence Period 4	Experimental	Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening Receives: Drug: Indacaterol 75 mcg; Drug: Placebo
Treatment Period Sequence 5	Experimental	Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening Receives: Drug: Indacaterol 150 mcg; Drug: Placebo
Treatment Period Sequence 6	Experimental	Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening Receives: Drug: Placebo

What is being measured

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

Change From Period Baseline in FEV1 (L) AUC(0-24h)
Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 will be measured pre-dose and over a 24 hours post-dose period.
Measured: Day 1 (24 hours)

Secondary outcomes (4)

Change From Period Baseline in FEV1 (L) AUC(0-12h) and FEV1 (L) AUC(12- 24h)
Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 will be measured pre-dose and over a 12 hours post-dose period.
Measured: Day 1 (12 hours)
Change From Period Baseline in Peak FEV1 (L)
Spirometry will be conducted according to internationally accepted standards. Peak Forced Expiratory Volume in 1 second (FEV1) is the maximum FEV1 recorded between different time points.
Measured: Day 1 (24 hours)
Change From Period Baseline in Trough FEV1 (L)
Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The trough in FEV1 is defined as the mean of two measurements at different time points.
Measured: Day 1 (24 hours)
Change From Period Baseline in FVC (L) AUC (0-24h)
Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC will be assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.
Measured: Day 1 (24 hours)

Timeline

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

Nov 2013Mar 2014

First posted10 Oct 2013 (estimated)
Study startNov 2013
Primary completionMar 2014
Study completionMar 2014

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01959412
Sponsor's protocol ID: CQVA149A2210
Acronym: QAB149
Status last verified: Apr 2015
First submitted: 8 Oct 2013
Last updated: 6 May 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Efficacy, Safety and Tolerability of Five Different Doses of Inhaled Indacaterol (QAB149) Delivered Via the Single Dose Dry Powder Inhaler (SDDPI) in Patients With Persistent Asthma
ClinicalTrials.gov ID: NCT01959412
Acronym / sponsor ID: QAB149 / CQVA149A2210
Conditions: Asthma
Keywords: wheezing, short of breath, laba, inhaler
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 91 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Nov 2013
Primary completion: Mar 2014 (actual)
Study completion: Mar 2014 (actual)
First posted: 10 Oct 2013 (estimated)
Results: Posted 6 May 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine the efficacy of indacaterol 55µg once daily (and 27.5 µg twice) in QVA149 compared to 75 µg indacaterol monotherapy.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
Treatment Period Sequence 1	Experimental	Drug: Indacaterol 27.5 mcg, Drug: PlaceboIndacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
Treatment Period Sequence 2	Experimental	Drug: Indacaterol 37.5, Drug: PlaceboIndacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
Treatment Period Sequence 3	Experimental	Drug: Indacaterol 55 mcg, Drug: PlaceboIndacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
Treatment Sequence Period 4	Experimental	Drug: Indacaterol 75 mcg, Drug: PlaceboIndacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
Treatment Period Sequence 5	Experimental	Drug: Indacaterol 150 mcg, Drug: PlaceboIndacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
Treatment Period Sequence 6	Experimental	Drug: PlaceboPlacebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening

Who may qualify

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

Key inclusion criteria (1 listed)

Asthma for at least 6 months, using inhaled corticosteroid for at least one month, foreced breath test less than below the normal value of the general population, -show an immediate improvement in breathing when given albuterol

Key exclusion criteria (1 listed)

patients who have smoked in the past 6 months or are currently smoking, including those who smoked more than a pack of cigarettes a day for at least 10 years, -patients who have a history of life-threatening asthma, -patients who have had an astham attack, in the last 6 weeks, requiring use of systemic steroids, hospitalization, or ER visit, -patients who have had a respiratory tract infection or worsening asthma between screening or run-in periods, patients requring use of other asthma-related drugs during the trial, other protocol-defined inclusion/exclusion may apply

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 27.5 mcgindacaterol 27.5 mcg twice daily inhaled once via inhaler	Drug	Treatment Period Sequence 1
Indacaterol 37.5Indacaterol 37.5 mcg once daily, inhaled once via inhaler	Drug	Treatment Period Sequence 2
Indacaterol 55 mcgIndacaterol 55 mcg once daily, inhaled once via inhaler	Drug	Treatment Period Sequence 3
Indacaterol 75 mcgIndacaterol 75 mcg once daily, inhaled once via inhaler	Drug	Treatment Sequence Period 4
Indacaterol 150 mcgIndacaterol 150 mcg once daily, inhaled once via inhaler	Drug	Treatment Period Sequence 5
PlaceboPlacebo to indacaterol once or twice daily (depending on assigned sequence) via inlaher	Drug	Treatment Period Sequence 1, Treatment Period Sequence 2, Treatment Period Sequence 3, Treatment Period Sequence 5, Treatment Period Sequence 6, Treatment Sequence Period 4

Primary outcome

Change From Period Baseline in FEV1 (L) AUC(0-24h)
Time frame: Day 1 (24 hours)
Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 will be measured pre-dose and over a 24 hours post-dose period.

4 secondary outcomes

Change From Period Baseline in FEV1 (L) AUC(0-12h) and FEV1 (L) AUC(12- 24h)
Time frame: Day 1 (12 hours)
Change From Period Baseline in Peak FEV1 (L)
Time frame: Day 1 (24 hours)
Change From Period Baseline in Trough FEV1 (L)
Time frame: Day 1 (24 hours)
Change From Period Baseline in FVC (L) AUC (0-24h)
Time frame: Day 1 (24 hours)

Results and safety

Results posted to the registry on 6 May 2015, 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 4 (Ind 150 μg)	15	14
Sequence 3 (Ind 75 μg)	15	14
Sequence 2 (Ind 55 μg)	15	15
Sequence 1 (Ind 37.5 μg)	15	13
Sequence 5 (Ind 27.5 μg)	16	13
Sequence 6 (Placebo)	15	15

Primary outcome: Change From Period Baseline in FEV1 (L) AUC(0-24h)

Time frame: Day 1 (24 hours). Least squares mean (Standard Error). Unit: Liters

Measure	Ind 150 μg n = 84	Ind 75 μg n = 86	Ind 55 μg n = 85	Ind 37.5 μg n = 84	Ind 27.5 n = 87	Placebo n = 86
Value	0.209 (0.0153)	0.165 (0.0152)	0.154 (0.0152)	0.121 (0.0153)	0.143 (0.0151)	0.022 (0.0152)

Population analysed: drug. Following the intent-to-treat principle, data for patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence. The FAS was used in the analysis of all efficacy variables

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ind 150 μg	0 of 88 (0%)	15 of 88 (17%)	Not reported
Ind 75 μg	1 of 87 (1.1%)	14 of 87 (16.1%)	Not reported
Ind 55 μg	1 of 86 (1.2%)	10 of 86 (11.6%)	Not reported
Ind 37.5 μg	1 of 85 (1.2%)	11 of 85 (12.9%)	Not reported
Ind 27.5	0 of 90 (0%)	12 of 90 (13.3%)	Not reported
Placebo	0 of 88 (0%)	9 of 88 (10.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
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

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Indacaterol 27.5 mcg, Indacaterol 37.5 and Indacaterol 55 mcg in people with Asthma, run by Novartis Pharmaceuticals at 12 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 1 inclusion and 1 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 6 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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. 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 6 May 2015). 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 Period Baseline in FEV1 (L) AUC(0-24h) (time frame: Day 1 (24 hours)). 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 NCT01959412.

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 6 May 2015; AzTrials last refreshed its copy on 30 Oct 2026.