AsthmaPhase 3NCT05776927
A Study to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometasone Furoate) Versus Salmeterol Xinafoate/Fluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma.
A Phase 3 study testing QVM149 and Salmeterol Xinafoate / Fluticasone Propionate in people with Asthma, run by Novartis Pharmaceuticals at 22 sites in 9 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of indacaterol acetate / glycopyrronium bromide / mometasone furoate (QVM149) compared to salmeterol xinafoate / fluticasone propionate in children from 12 to less than 18 years of age with asthma with pre-bronchodilator FEV1 ≥ 50 % of the predicted… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Asthma
- What is being tested?
- QVM149 and Salmeterol Xinafoate / Fluticasone Propionate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- 22 sitesin 9 countries
- Study dates
- 4 Aug 2026to 30 Jan 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female adolescent participants aged from ≥ 12 years old to less than 18 years old at screening visit
- Participants with a documented diagnosis of persistent asthma (according to Global Initiative for Asthma GINA 2024) for a period of at least 1 year prior to screening.
- Participants who have used medium or high dose ICS with LABA in combination (GINA 2024) for asthma for at least 3 months and at stable doses for at least 1 month prior to screening
- Participants must be symptomatic / inadequately controlled according to the Investigator's opinion despite treatment with medium or high stable doses of ICS with LABA in combination (GINA 2024) before screening
- Participants who demonstrate an increase in FEV1 of ≥ 12% within 15 to 30 minutes after administration of 200-400 μg salbutamol/180-360 μg albuterol at run-in visit
- Pre-bronchodilator FEV1 ≥ 50% of the predicted normal value for the participant according to American Thoracic Society/European Respiratory Society (ATS/ERS) 2019 criteria at both run-in and before randomization
Who cannot join
- Participants who have had a severe asthma attack/exacerbation requiring systemic steroids OR hospitalization (> 24 hours) OR emergency room (ER) visit (≤ 24 hours) within 6 weeks of screening. If participants experience an asthma attack/exacerbation requiring systemic steroids or emergency room visit between screening and end of run-in they may be re-screened 6 weeks after recovery from the exacerbation
- Participants who have ever required intubation for a severe asthma attack/exacerbation
- Participants with a history of chronic lung diseases other than asthma, including (but not limited to) sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis
- Participants with Type I diabetes or uncontrolled Type II diabetes
- Participants who have a clinically significant laboratory abnormality as per investigator judgement before the end of run-in
- Participants with a history of myocardial infarction (this should be confirmed clinically by the Investigator) within the previous 12 months
Show all 10Show fewer
- Participants with a history of long QT syndrome or a family history of a first degree relative with sudden cardiac death under the age of 50 years, or participants whose QTc measured at run-in or at baseline (prior to randomization) (Fridericia method) is prolonged (> 450 msec for males and > 460 msec for females) and confirmed by a central assessor or the inability to determine the QT interval corrected by Fridericia's formula (QTcF) interval (these participants should not be re-screened)
- Female participants of childbearing potential defined as all females physiologically capable of becoming pregnant (e.g. are menstruating) who do not agree to abstinence or, if sexually active, do not agree to the use of contraception as defined in the exclusion criteria
- Use of long-acting muscarinic antagonist (LAMA) within 3 months prior to screening
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
22 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
22 sites in 9 countries
Poland6 sites, 6 recruiting
- Recruiting
Novartis Investigative Site
Bialystok, 15-698
- Recruiting
Novartis Investigative Site
Krakow, 31-625
- Recruiting
Novartis Investigative Site
Lublin, 20-637
- Recruiting
Novartis Investigative Site
Piaseczno, 05-500
- Recruiting
Novartis Investigative Site
Tarnów, Poland, 33-100
- Recruiting
Novartis Investigative Site
Torun, 87-100
South Africa6 sites, 6 recruiting
- Recruiting
Novartis Investigative Site
Cape Town, 7531
- Recruiting
Novartis Investigative Site
East London, Eastern Cape, 5201
- Recruiting
Novartis Investigative Site
Germiston, Gauteng, 1401
- Recruiting
Novartis Investigative Site
Krugersdorp, Gauteng, 1739
- Recruiting
Novartis Investigative Site
Lenasia, Gauteng, 1827
- Recruiting
Novartis Investigative Site
Paarl, Western Cape, 7626
Spain3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Sabadell, Barcelona, 08208
- Recruiting
Novartis Investigative Site
Santiago Compostela, A Coruna, 15706
- Recruiting
Novartis Investigative Site
Seville, 41013
Slovakia2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Bratislava, Mestska Cast Ruzinov, 821 08
- Recruiting
Novartis Investigative Site
Košice, 040 22
Argentina1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Rosario, Santa Fe Province, S2000DIF
France1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Strasbourg, 67091
Hungary1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Szeged, 6720
Romania1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Bucharest, 050159
Taiwan1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Kaohsiung City, 833
About this study
Official title: A Double-dummy, Double-blind, Randomized, Active Controlled, Two-way Cross-over Study With 12 Week Treatment Duration Period, to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometasone Furoate) Compared to Salmeterol Xinafoate/Fluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma.
The purpose of this study is to evaluate the efficacy and safety of indacaterol acetate / glycopyrronium bromide / mometasone furoate (QVM149) compared to salmeterol xinafoate / fluticasone propionate in children from 12 to less than 18 years of age with asthma with pre-bronchodilator FEV1 ≥ 50 % of the predicted normal value for the participant.
Read the detailed description
This is a double-dummy, double-blind, randomized, active controlled, two-way two-period treatment (12 weeks duration each) cross-over study.
The study duration of 36 weeks includes:
- a screening period of up to 15 days (rescue medication: short acting β2-agonist (SABA) salbutamol 100 μg or albuterol 90 μg via a Metered-Dose Inhaler (MDI) to use as-needed throughout the study).
- a run-in period of 14 days (run-in medication: salmeterol xinafoate 50 μg / fluticasone propionate 250μg bid delivered via Girohaler® or equivalent DPI device)
- two treatment period of 12 weeks each (either QVM149 150/50/160 µg od and placebo to salmeterol xinafoate/fluticasone propionate 50/500 µg bid, or salmeterol xinafoate/fluticasone propionate 50/500 µg bid and placebo to QVM149 150/50/160 µg od, separated by a 3 week washout period (wash-out medication: salmeterol xinafoate/fluticasone propionate 50/250 µg bid)
- a safety follow up period of 30 days during which the participant will be back on standard of care treatment as appropriate.
- Conditions
- Asthma
- Being tested
- QVM149, Salmeterol Xinafoate / Fluticasone Propionate, Placebo to QVM149, Placebo to salmeterol xinafoate / fluticasone propionate
- Keywords
- Asthma, Adolescent, QVM149, Pediatric, LABA, LAMA, ICS, Triple Combination
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QVM149Drug
QVM149: Indacaterol as acetate 150 µg / glycopyrronium as bromide 50 µg / mometasone furoate 160 µg once daily delivered via Breezhaler®
Salmeterol Xinafoate / Fluticasone PropionateDrug
Salmeterol xinafoate 50 μg / fluticasone propionate 500 μg twice daily delivered via Girohaler®
Placebo to QVM149Drug
Placebo to QVM149 150/50/160 µg once daily delivered via Breezhaler®
Placebo to salmeterol xinafoate / fluticasone propionateDrug
Placebo to salmeterol xinafoate/fluticasone propionate 50/500 μg twice daily delivered via Girohaler®
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: QVM149 first, then salmeterol xinafoate/fluticasone propionate | Experimental | * QVM149 150/50/160 µg od and placebo to salmeterol xinafoate/fluticasone propionate 50/500 μg bid during treatment period 1.
* Then, after a 3-week washout period, salmeterol xinafoate/fluticasone propionate 50/500 μg bid and placebo to QVM149 150/50/160 µg od during treatment period 2. Receives: Drug: QVM149; Drug: Salmeterol Xinafoate / Fluticasone Propionate; Drug: Placebo to QVM149; Drug: Placebo to salmeterol xinafoate / fluticasone propionate |
| Arm 2: Salmeterol xinafoate/fluticasone propionate first, then QVM149 | Experimental | * Salmeterol xinafoate/fluticasone propionate 50/500 μg bid and placebo to QVM149 150/50/160 µg od during treatment period 1.
* Then, after a 3-week washout period, QVM149 150/50/160 µg od and placebo to salmeterol xinafoate/fluticasone propionate 50/500 μg bid during treatment period 2. Receives: Drug: QVM149; Drug: Salmeterol Xinafoate / Fluticasone Propionate; Drug: Placebo to QVM149; Drug: Placebo to salmeterol xinafoate / fluticasone propionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Trough FEV1
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.
Measured: Baseline, Week 12 of each treatment period.
Secondary outcomes (5)
Change from Baseline in Asthma Control Questionnaire (ACQ-5) score
The ACQ-5 is a five-item, self-completed questionnaire, which is used as a measure of asthma control of a participant. The five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) enquire about the frequency and/or severity of symptoms over the previous week. The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/ limitation) scale. ACQ-5 score range from 0 to 6. Higher scores indicates worsening of condition.
Measured: Baseline, Week 12 of each treatment period
Change from Baseline in Pediatric Asthma Quality of Life Questionnaire (PAQLQ) total score
Pediatric Asthma Quality of Life Questionnaire is a 23-item disease specific questionnaire designed to measure functional impairments that are most important to patients with asthma, with 7-point scale (7-not bothered at all, 1-extremely bothered). It consists of 3 domains: symptoms, activity limitation and emotional function. Higher scores indicate less impairment in HRQOL.
The overall PAQLQ score is the mean of all 23 responses and the individual domain scores are the means of the items in those domains.
Measured: Baseline, Week 12 of each treatment period
Change from Baseline in average Rescue medication use (daily, daytime, and nighttime)
Rescue medication use over 12 weeks of each treatment period.
Measured: Baseline, Week 12 of each treatment period
Number and severity of reported asthma exacerbations
Asthma exacerbations over 12 weeks of each treatment period
Measured: Baseline, Week 12 of each treatment period
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with AEs and SAEs, including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.
Measured: From first dose up to 30 days after last dose (up to 31 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start4 Aug 2026
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Model description
- A double-dummy, double-blind, randomized, active controlled study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 188 participants (estimated)
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
- NCT05776927
- Sponsor's protocol ID
- CQVM149C2301
- Other IDs
- 2022-502365-26
- Status last verified
- Oct 2026
- First submitted
- 6 Mar 2023
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-dummy, Double-blind, Randomized, Active Controlled, Two-way Cross-over Study With 12 Week Treatment Duration Period, to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometasone Furoate) Compared to Salmeterol Xinafoate/Fluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma.
- ClinicalTrials.gov ID
- NCT05776927
- Acronym / sponsor ID
- CQVM149C2301
- Conditions
- Asthma
- Keywords
- Asthma, Adolescent, QVM149, Pediatric, LABA, LAMA, ICS, Triple Combination
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2026 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Jan 2029 (estimated)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
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 evaluate the efficacy and safety of indacaterol acetate / glycopyrronium bromide / mometasone furoate (QVM149) compared to salmeterol xinafoate / fluticasone propionate in children from 12 to less than 18 years of age with asthma with pre-bronchodilator FEV1 ≥ 50 % of the predicted normal value for the participant.
Detailed description
This is a double-dummy, double-blind, randomized, active controlled, two-way two-period treatment (12 weeks duration each) cross-over study.
The study duration of 36 weeks includes:
- a screening period of up to 15 days (rescue medication: short acting β2-agonist (SABA) salbutamol 100 μg or albuterol 90 μg via a Metered-Dose Inhaler (MDI) to use as-needed throughout the study).
- a run-in period of 14 days (run-in medication: salmeterol xinafoate 50 μg / fluticasone propionate 250μg bid delivered via Girohaler® or equivalent DPI device)
- two treatment period of 12 weeks each (either QVM149 150/50/160 µg od and placebo to salmeterol xinafoate/fluticasone propionate 50/500 µg bid, or salmeterol xinafoate/fluticasone propionate 50/500 µg bid and placebo to QVM149 150/50/160 µg od, separated by a 3 week washout period (wash-out medication: salmeterol xinafoate/fluticasone propionate 50/250 µg bid)
- a safety follow up period of 30 days during which the participant will be back on standard of care treatment as appropriate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A double-dummy, double-blind, randomized, active controlled study.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: QVM149 first, then salmeterol xinafoate/fluticasone propionate | Experimental | Drug: QVM149, Drug: Salmeterol Xinafoate / Fluticasone Propionate, Drug: Placebo to QVM149, Drug: Placebo to salmeterol xinafoate / fluticasone propionate* QVM149 150/50/160 µg od and placebo to salmeterol xinafoate/fluticasone propionate 50/500 μg bid during treatment period 1. * Then, after a 3-week washout period, salmeterol xinafoate/fluticasone propionate 50/500 μg bid and placebo to QVM149 150/50/160 µg od during treatment period 2. |
| Arm 2: Salmeterol xinafoate/fluticasone propionate first, then QVM149 | Experimental | Drug: QVM149, Drug: Salmeterol Xinafoate / Fluticasone Propionate, Drug: Placebo to QVM149, Drug: Placebo to salmeterol xinafoate / fluticasone propionate* Salmeterol xinafoate/fluticasone propionate 50/500 μg bid and placebo to QVM149 150/50/160 µg od during treatment period 1. * Then, after a 3-week washout period, QVM149 150/50/160 µg od and placebo to salmeterol xinafoate/fluticasone propionate 50/500 μg bid during treatment period 2. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Male and female adolescent participants aged from ≥ 12 years old to less than 18 years old at screening visit
- Participants with a documented diagnosis of persistent asthma (according to Global Initiative for Asthma GINA 2024) for a period of at least 1 year prior to screening.
- Participants who have used medium or high dose ICS with LABA in combination (GINA 2024) for asthma for at least 3 months and at stable doses for at least 1 month prior to screening
- Participants must be symptomatic / inadequately controlled according to the Investigator's opinion despite treatment with medium or high stable doses of ICS with LABA in combination (GINA 2024) before screening
- Participants who demonstrate an increase in FEV1 of ≥ 12% within 15 to 30 minutes after administration of 200-400 μg salbutamol/180-360 μg albuterol at run-in visit
Key exclusion criteria (10 listed)
- Participants who have had a severe asthma attack/exacerbation requiring systemic steroids OR hospitalization (> 24 hours) OR emergency room (ER) visit (≤ 24 hours) within 6 weeks of screening. If participants experience an asthma attack/exacerbation requiring systemic steroids or emergency room visit between screening and end of run-in they may be re-screened 6 weeks after recovery from the exacerbation
- Participants who have ever required intubation for a severe asthma attack/exacerbation
- Participants with a history of chronic lung diseases other than asthma, including (but not limited to) sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis
- Participants with Type I diabetes or uncontrolled Type II diabetes
- Participants who have a clinically significant laboratory abnormality as per investigator judgement before the end of run-in
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 |
|---|---|---|
| QVM149QVM149: Indacaterol as acetate 150 µg / glycopyrronium as bromide 50 µg / mometasone furoate 160 µg once daily delivered via Breezhaler® | Drug | Arm 1: QVM149 first, then salmeterol xinafoate/fluticasone propionate, Arm 2: Salmeterol xinafoate/fluticasone propionate first, then QVM149 |
| Salmeterol Xinafoate / Fluticasone PropionateSalmeterol xinafoate 50 μg / fluticasone propionate 500 μg twice daily delivered via Girohaler® | Drug | Arm 1: QVM149 first, then salmeterol xinafoate/fluticasone propionate, Arm 2: Salmeterol xinafoate/fluticasone propionate first, then QVM149 |
| Placebo to QVM149Placebo to QVM149 150/50/160 µg once daily delivered via Breezhaler® | Drug | Arm 1: QVM149 first, then salmeterol xinafoate/fluticasone propionate, Arm 2: Salmeterol xinafoate/fluticasone propionate first, then QVM149 |
| Placebo to salmeterol xinafoate / fluticasone propionatePlacebo to salmeterol xinafoate/fluticasone propionate 50/500 μg twice daily delivered via Girohaler® | Drug | Arm 1: QVM149 first, then salmeterol xinafoate/fluticasone propionate, Arm 2: Salmeterol xinafoate/fluticasone propionate first, then QVM149 |
Primary outcome
Change from Baseline in Trough FEV1
Time frame: Baseline, Week 12 of each treatment period.
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.
5 secondary outcomes
Change from Baseline in Asthma Control Questionnaire (ACQ-5) score
Time frame: Baseline, Week 12 of each treatment period
Change from Baseline in Pediatric Asthma Quality of Life Questionnaire (PAQLQ) total score
Time frame: Baseline, Week 12 of each treatment period
Change from Baseline in average Rescue medication use (daily, daytime, and nighttime)
Time frame: Baseline, Week 12 of each treatment period
Number and severity of reported asthma exacerbations
Time frame: Baseline, Week 12 of each treatment period
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From first dose up to 30 days after last dose (up to 31 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
22 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing QVM149 and Salmeterol Xinafoate / Fluticasone Propionate in people with Asthma, run by Novartis Pharmaceuticals at 22 sites in 9 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 6 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Poland, South Africa, Spain, Slovakia, Argentina and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Trough FEV1 (time frame: Baseline, Week 12 of each treatment period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2026.