AsthmaPhase 2NCT02892019
Efficacy and Safety of Indacaterol Acetate Delivered Via the Concept1 Inhalation Device in Children Greater or Equal to 6 and Less Than 12 Years of Age With Asthma
A Phase 2 study testing Indacaterol acetate 75 μg and Indacaterol acetate 150 μg in people with Asthma, run by Novartis Pharmaceuticals at 29 sites in 11 countries.
Trial summary
This study is designed to explore lung function effects of two doses of indacaterol acetate, 75 μg and 150 μg, in pediatric asthma patients 6-11 years old, and to compare the systemic exposure to indacaterol in plasma with historical data in adults, to identify an appropriate dose to Phase III evaluation. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Asthma
- What is being tested?
- Indacaterol acetate 75 μg and Indacaterol acetate 150 μg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 29 sitesin 11 countries
- Study dates
- 18 Apr 2017to 17 Jul 2019
- 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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female children ≥ 6 years and < 12 years with confirmed diagnosis of asthma for at least 1 year prior to study enrollment.
- Written informed consent by parent(s)/legal guardian(s) and depending upon their age and local requirements a consent or assent for the patient.
- Patients receiving daily treatment with a stable low dose Inhaled Corticosteroid (ICS) (with or without additional controller), or patients receiving daily treatment with a stable mid-dose ICS (monotherapy or together with LTRA) for at least 4 weeks prior to Screening, and able to tolerate fluticasone propionate 100 μg b.i.d. inhaler starting at Visit 1 (or soon after).
- Patients with a pre-bronchodilator FEV1 ≥ 50% and ≤ 90% of the predicted normal value for the patient at the start and end of Run-in (Visits 101 and 199).
- Patients who demonstrate an increase in FEV1 of 12% within 30 minutes after administration of 400 μg salbutamol/360 μg albuterol (or equivalent dose) at Visit 101. All patients must perform a reversibility test at Visit 101.
Who cannot join
- Patients taking a mid-dose ICS (per GINA guidelines) in combination with LABA or any patient taking high-dose ICS.
- Evidence of unstable disease within 4 weeks prior to Screening (Visit 1).
- Patients who have had an asthma attack/exacerbation requiring systemic steroids (SCS) or hospitalization or emergency room visit within 3 months prior to Visit 1 (Screening) or more than 3 separate exacerbations in the 12 months preceding Visit 1.
- Suspected or documented bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of Screening (Visit 1).
- Prior intubation for asthma.
Trial locations and contacts
29 sites in 11 countries.
29 sites in 11 countries
Hungary4 sites
Novartis Investigative Site
Budapest, 1083
Novartis Investigative Site
Szeged, 6720
Novartis Investigative Site
Szigetvár, 7900
Novartis Investigative Site
Törökbálint, Pest County, 2045
South Africa4 sites
Novartis Investigative Site
Cape Town, 7531
Novartis Investigative Site
Cape Town, 7700
Novartis Investigative Site
Middelburg, Mpumalanga, 1050
Novartis Investigative Site
Panorama, Western Cape, 7500
Germany3 sites
Novartis Investigative Site
Hamm, D 59063
Novartis Investigative Site
Mannheim, 68161
Novartis Investigative Site
Rosenheim, 83026
Guatemala3 sites
Novartis Investigative Site
Guatemala City, GTM, 01010
Novartis Investigative Site
Guatemala City, 01011
Novartis Investigative Site
Guatemala City, 01015
Philippines3 sites
Novartis Investigative Site
Manila, National Capital Region, 1000
Novartis Investigative Site
Manila, 1008
Novartis Investigative Site
Quezon City, 1113
Belgium2 sites
Novartis Investigative Site
Bruges, 8000
Novartis Investigative Site
Brussels, 1020
Colombia2 sites
Novartis Investigative Site
Bogotá
Novartis Investigative Site
Bucaramanga
Croatia2 sites
Novartis Investigative Site
Slavonski Brod, 35000
Novartis Investigative Site
Zagreb, 10000
Russia2 sites
Novartis Investigative Site
Saint Petersburg, 196240
Novartis Investigative Site
Saint Petersburg, 199106
Slovakia2 sites
Novartis Investigative Site
Nitra, Slovak Republic, 949 01
Novartis Investigative Site
Nové Zámky, SVK, 94001
Turkey (Türkiye)2 sites
Novartis Investigative Site
Adana, 01330
Novartis Investigative Site
Ankara, 06100
About this study
Official title: A Multicenter, Randomized, Double-blind, Active-controlled, 2 Week Treatment, Parallel-group Study to Assess the Efficacy and Safety of Indacaterol Acetate Delivered Via the Concept1 Inhalation Device in Children Greater or Equal to 6 and Less Than 12 Years of Age With Asthma
This study is designed to explore lung function effects of two doses of indacaterol acetate, 75 μg and 150 μg, in pediatric asthma patients 6-11 years old, and to compare the systemic exposure to indacaterol in plasma with historical data in adults, to identify an appropriate dose to Phase III evaluation.
- Conditions
- Asthma
- Being tested
- Indacaterol acetate 75 μg, Indacaterol acetate 150 μg
- Keywords
- indacaterol acetate, asthma, GINA 2015, pediatrics
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indacaterol acetate 75 μgDrug
Also called QAB149
Indacaterol acetate 75 μg o.d. delivered via Concept1 inhaler
Indacaterol acetate 150 μgDrug
Also called QAB149
Indacaterol acetate 150 μg o.d. delivered via Concept1 inhaler
| Study group | Role | What they receive |
|---|---|---|
| Indacaterol acetate 75 μg o.d. | Active comparator | Indacaterol acetate 75 μg o.d. delivered via Concept1 inhaler Receives: Drug: Indacaterol acetate 75 μg |
| Indacaterol acetate 150 μg o.d. | Active comparator | Indacaterol acetate 150 μg o.d. delivered via Concept1 inhaler Receives: Drug: Indacaterol acetate 150 μg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trough Forced Expiratoty Volume in 1 Second (FEV1)
Change from baseline in pre-dose trough FEV1 after 2 weeks of treatment with indacaterol acetate 75 μg o.d and 150 μg o.d.
The primary endpoint is change from baseline in pre-dose trough FEV1 (mL) after 2 weeks of treatment. The pre-dose trough FEV1 (mL) is defined as the mean of the two FEV1 (mL), values measured at -45 min and -15 min pre-dose.
Measured: 2 weeks
Secondary outcomes (8)
Systemic Exposure to Indacaterol in Plasma
Systemic exposure to indacaterol in plasma following sparse pharmacokinetic (PK) sampling on Day 1 and Day 14 after inhalation of indacaterol acetate 75 μg and 150 μg.
Measured: day 1, day 14
Asthma Control as Assessed by Pediatric Interviewer-administered Asthma Control Questionnaire
Asthma Control as assessed by pediatric interviewer-administered Asthma Control Questionnaire (ACQ-IA) score at week 2 (mean change). A decrease in the score shows an improvement.
The scale ranges from 0 (no symptoms) to 6 (severe symptoms every day). Results are given as a change as compared from baseline
Measured: 2 weeks
Pre-dose Morning and Evening Peak Expiratoty Flow (PEF)
Pre-dose morning and evening PEF over 2 weeks of treatment as determined by electronic peak flow meter data (mean change)
Measured: 2 weeks
Rescue Medication Usage (Mean Daiily Number of Puffs)
Rescue medication usage over 2 weeks of treatment as determined by patient diary data for indacaterol acetate 75 μg and 150 μg o.d.Results given as mean change of puffs of rescue medication.
Measured: 2 weeks
Rescue Medication Usage (Percentage of Rescue Medication Free Days)
Rescue medication usage over 2 weeks of treatment as determined by patient diary data for indacaterol acetate 75 μg and 150 μg o.d.
Measured: 2 weeks
Forced Expiratoty Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC)
FEV1 and FVC at 30 minutes and 1-hour post dose at week 2 for indacaterol acetate 75 μg and 150 μg o.d.
Measured: 2 weeks
Symptoms as Recorded by Patient E-diary (Mean Total Daily Symptom Score)
Symptoms as recorded by patient e-diary for indacaterol acetate 75 μg and 150 μg o.d. (mean change) The scale rages from 0 (no problem) - 4 (very severe problems).
Measured: 2 weeks
Symptoms as Recorded by Patient E-diary (Percentage of Asthma Symptoms Free Days)
Symptoms as recorded by patient e-diary for indacaterol acetate 75 μg and 150 μg o.d. (mean change)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study start18 Apr 2017
- Primary completion19 Jun 2019
- Study completion17 Jul 2019
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 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
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02892019
- Sponsor's protocol ID
- CQMF149G2202
- Other IDs
- 2016-002113-21, 2016
- Status last verified
- Jan 2020
- First submitted
- 1 Sep 2016
- Last updated
- 27 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Publications
Sekerel BE, Nell H, Laki I, Pak T, Contreras E, Kolarz A, D'Andrea P, Manga V, Jain M, Vaidya S, Valentin M, Sen B. Efficacy, Safety, and Systemic Exposure of Once-Daily Indacaterol Acetate in Pediatric Asthma: A Randomized, Double-Blind, Controlled Dose-Finding Study. Clin Drug Investig. 2023 Sep;43(9):719-728. doi: 10.1007/s40261-023-01300-8. Epub 2023 Sep 8.
PubMed 37682405
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Active-controlled, 2 Week Treatment, Parallel-group Study to Assess the Efficacy and Safety of Indacaterol Acetate Delivered Via the Concept1 Inhalation Device in Children Greater or Equal to 6 and Less Than 12 Years of Age With Asthma
- ClinicalTrials.gov ID
- NCT02892019
- Acronym / sponsor ID
- CQMF149G2202
- Conditions
- Asthma
- Keywords
- indacaterol acetate, asthma, GINA 2015, pediatrics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2017 (actual)
- Primary completion
- 19 Jun 2019 (actual)
- Study completion
- 17 Jul 2019 (actual)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Posted 27 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to explore lung function effects of two doses of indacaterol acetate, 75 μg and 150 μg, in pediatric asthma patients 6-11 years old, and to compare the systemic exposure to indacaterol in plasma with historical data in adults, to identify an appropriate dose to Phase III evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indacaterol acetate 75 μg o.d. | Active comparator | Drug: Indacaterol acetate 75 μgIndacaterol acetate 75 μg o.d. delivered via Concept1 inhaler |
| Indacaterol acetate 150 μg o.d. | Active comparator | Drug: Indacaterol acetate 150 μgIndacaterol acetate 150 μg o.d. delivered via Concept1 inhaler |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Male and female children ≥ 6 years and < 12 years with confirmed diagnosis of asthma for at least 1 year prior to study enrollment.
- Written informed consent by parent(s)/legal guardian(s) and depending upon their age and local requirements a consent or assent for the patient.
- Patients receiving daily treatment with a stable low dose Inhaled Corticosteroid (ICS) (with or without additional controller), or patients receiving daily treatment with a stable mid-dose ICS (monotherapy or together with LTRA) for at least 4 weeks prior to Screening, and able to tolerate fluticasone propionate 100 μg b.i.d. inhaler starting at Visit 1 (or soon after).
- Patients with a pre-bronchodilator FEV1 ≥ 50% and ≤ 90% of the predicted normal value for the patient at the start and end of Run-in (Visits 101 and 199).
- Patients who demonstrate an increase in FEV1 of 12% within 30 minutes after administration of 400 μg salbutamol/360 μg albuterol (or equivalent dose) at Visit 101. All patients must perform a reversibility test at Visit 101.
Key exclusion criteria (5 listed)
- Patients taking a mid-dose ICS (per GINA guidelines) in combination with LABA or any patient taking high-dose ICS.
- Evidence of unstable disease within 4 weeks prior to Screening (Visit 1).
- Patients who have had an asthma attack/exacerbation requiring systemic steroids (SCS) or hospitalization or emergency room visit within 3 months prior to Visit 1 (Screening) or more than 3 separate exacerbations in the 12 months preceding Visit 1.
- Suspected or documented bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of Screening (Visit 1).
- Prior intubation for 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 |
|---|---|---|
| Indacaterol acetate 75 μgAlso: QAB149Indacaterol acetate 75 μg o.d. delivered via Concept1 inhaler | Drug | Indacaterol acetate 75 μg o.d. |
| Indacaterol acetate 150 μgAlso: QAB149Indacaterol acetate 150 μg o.d. delivered via Concept1 inhaler | Drug | Indacaterol acetate 150 μg o.d. |
Primary outcome
Trough Forced Expiratoty Volume in 1 Second (FEV1)
Time frame: 2 weeks
Change from baseline in pre-dose trough FEV1 after 2 weeks of treatment with indacaterol acetate 75 μg o.d and 150 μg o.d. The primary endpoint is change from baseline in pre-dose trough FEV1 (mL) after 2 weeks of treatment. The pre-dose trough FEV1 (mL) is defined as the mean of the two FEV1 (mL), values measured at -45 min and -15 min pre-dose.
8 secondary outcomes
Systemic Exposure to Indacaterol in Plasma
Time frame: day 1, day 14
Asthma Control as Assessed by Pediatric Interviewer-administered Asthma Control Questionnaire
Time frame: 2 weeks
Pre-dose Morning and Evening Peak Expiratoty Flow (PEF)
Time frame: 2 weeks
Rescue Medication Usage (Mean Daiily Number of Puffs)
Time frame: 2 weeks
Rescue Medication Usage (Percentage of Rescue Medication Free Days)
Time frame: 2 weeks
Forced Expiratoty Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC)
Time frame: 2 weeks
Symptoms as Recorded by Patient E-diary (Mean Total Daily Symptom Score)
Time frame: 2 weeks
Symptoms as Recorded by Patient E-diary (Percentage of Asthma Symptoms Free Days)
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37682405Sekerel BE, Nell H, Laki I, Pak T, Contreras E, Kolarz A, D'Andrea P, Manga V, Jain M, Vaidya S, Valentin M, Sen B. Efficacy, Safety, and Systemic Exposure of Once-Daily Indacaterol Acetate in Pediatric Asthma: A Randomized, Double-Blind, Controlled Dose-Finding Study. Clin Drug Investig. 2023 Sep;43(9):719-728. doi: 10.1007/s40261-023-01300-8. Epub 2023 Sep 8.
- Individual participant dataSharing planned: Undecided. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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
29 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Indacaterol acetate 75 μg and Indacaterol acetate 150 μg in people with Asthma, run by Novartis Pharmaceuticals at 29 sites in 11 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 5 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 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Hungary, South Africa, Germany, Guatemala, Philippines and 6 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 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 27 Jan 2020). 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 Expiratoty Volume in 1 Second (FEV1) (time frame: 2 weeks). 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 NCT02892019, 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 27 Jan 2020.