AsthmaPhase 2NCT03063086
Assess Bronchodilator Effect and Safety of Two Doses of QVM149 Compared to a Fixed Dose Combination of Salmeterol/Fluticasone in Patients With Asthma.
A Phase 2 study testing QVM149 150/50/80 μg o.d., QVM149 150/50/160 μg o.d. and salmeterol/fluticasone FDC 50/500 μg b.i.d. in people with Asthma, run by Novartis Pharmaceuticals at 12 sites in 6 countries.
Trial summary
The purpose of this study is to assess peak FEV1 of two doses of QVM149 compared to a fixed-dose combination of salmeterol/fluticasone (50/500μg b.i.d.) and to characterize the respective 24 hour bronchodilator effect profiles in patients with asthma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- QVM149 150/50/80 μg o.d., QVM149 150/50/160 μg o.d. and salmeterol/fluticasone FDC 50/500 μg b.i.d.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 12 sitesin 6 countries
- Study dates
- 21 Jan 2017to 2 Aug 2018
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female adult patients ≥ 18 years old and ≤ 75 years.
- Patients with a documented physician diagnosis of asthma for a period of at least 12 months prior to Visit 1 (Screening).
- Patients who have used ICS and LABA combinations for asthma for at least 3 month and at a stable medium or high dose of ICS for at least 1 month prior to Visit 1 (Screening).
- Pre-bronchodilator FEV1 of < 80 % of the predicted normal value at screening Visit 1 (spirometry will not be repeated at baseline prior to randomization).
- Patients who demonstrate an increase in FEV1 of ≥ 12 % and 200 mL after administration of 400 µg salbutamol/360 µg albuterol (or equivalent do se) at Visit 1 (Screening). All patients must perform a reversibility test at Visit 1 (Screening). If reversibility is not demonstrated at Visit 1 (Screening), then, reversibility testing may be repeated once during the screening period.
- If reversibility is not demonstrated at Visit 1 (retesting allowed once), patients must be screen failed. Spacer devices are not permitted during reversibility testing Key Exclusion criteria
Show all 23Show fewer
- Patients who have smoked or inhaled tobacco products within the 6 month period prior to Visit 1
- Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 6 weeks of Visit 1
- Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia (BPH) or bladder-neck obstruction or severe renal impairment or urinary retention
- Patients who have had a respiratory tract infection or asthma worsening within 4 weeks prior to Visit 1
- Patients with any chronic conditions affecting the upper respiratory tract
- Patients with a history of chronic lung diseases other than asthma, including (but not limited to) COPD, sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis.
- Patients with Type I diabetes or uncontrolled Type II diabetes (HbA1c >9% at screening).
- Patients who have a clinically significant ECG abnormality at Visit 1
- Patients with a history of hypersensitivity or intolerance to any of the study drugs (including excipients)
- Patients with narcolepsy and/or insomnia.
- Patients on Maintenance Immunotherapy (desensitization) for allergies for less than 3 months prior to Visit 2 or patients on Maintenance Immunotherapy for more than 3 months prior to Visit 2 but expected to change throughout the course of the study.
- Pregnant or nursing (lactating) women
- Women of child-bearing potential must use Highly effective contraception methods
- Patients who have discontinued LAMA therapy in the past for any safety, tolerability or perceived lack of efficacy reason.
- History of paradoxical bronchospasm in response to inhaled medicines.
- Patients with a history of clinically relevant bronchoconstriction upon repeated forced expiratory maneuvers.
- Patient with a serum potassium level below the laboratory limit of normal at screening.
Who cannot join
None listed.
Trial locations and contacts
12 sites in 6 countries.
12 sites in 6 countries
Germany5 sites
Novartis Investigative Site
Berlin, 10117
Novartis Investigative Site
Frankfurt, 60596
Novartis Investigative Site
Großhansdorf, 22947
Novartis Investigative Site
Hanover, 30625
Novartis Investigative Site
Wiesbaden, 65187
China3 sites
Novartis Investigative Site
Changchun, Jilin, 130021
Novartis Investigative Site
Shanghai, 200433
Novartis Investigative Site
Tianjin, Tianjin Municipality, 300192
About this study
Official title: A Randomized, Double-blind, Double-dummy, Active-controlled, 3-period Complete Cross-over Study to Assess the Bronchodilator Effect and Safety of Two Doses of QVM149 Compared to a Fixed Dose Combination of Salmeterol/Fluticasone in Patients With Asthma
The purpose of this study is to assess peak FEV1 of two doses of QVM149 compared to a fixed-dose combination of salmeterol/fluticasone (50/500μg b.i.d.) and to characterize the respective 24 hour bronchodilator effect profiles in patients with asthma. Data from this study will complement lung function data obtained in the pivotal QVM149 phase 3 program by assessing the bronchodilatory effect of QVM149 at multiple time-points over an entire dosing interval of 24 hours.
- Conditions
- Asthma
- Being tested
- QVM149 150/50/80 μg o.d., QVM149 150/50/160 μg o.d., salmeterol/fluticasone FDC 50/500 μg b.i.d.
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QVM149 150/50/80 μg o.d.Drug
A
QVM149 150/50/160 μg o.d.Drug
B
salmeterol/fluticasone FDC 50/500 μg b.i.d.Drug
C
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Active comparator | A-B-C Receives: Drug: QVM149 150/50/80 μg o.d.; Drug: QVM149 150/50/160 μg o.d.; Drug: salmeterol/fluticasone FDC 50/500 μg b.i.d. |
| Sequence 2 | Active comparator | A-C-B Receives: Drug: QVM149 150/50/80 μg o.d.; Drug: QVM149 150/50/160 μg o.d.; Drug: salmeterol/fluticasone FDC 50/500 μg b.i.d. |
| Sequence 3 | Active comparator | B-C-A Receives: Drug: QVM149 150/50/80 μg o.d.; Drug: QVM149 150/50/160 μg o.d.; Drug: salmeterol/fluticasone FDC 50/500 μg b.i.d. |
| Sequence 4 | Active comparator | B-A-C Receives: Drug: QVM149 150/50/80 μg o.d.; Drug: QVM149 150/50/160 μg o.d.; Drug: salmeterol/fluticasone FDC 50/500 μg b.i.d. |
| Sequence 5 | Active comparator | C-A-B Receives: Drug: QVM149 150/50/80 μg o.d.; Drug: QVM149 150/50/160 μg o.d.; Drug: salmeterol/fluticasone FDC 50/500 μg b.i.d. |
| Sequence 6 | Active comparator | C-B-A Receives: Drug: QVM149 150/50/80 μg o.d.; Drug: QVM149 150/50/160 μg o.d.; Drug: salmeterol/fluticasone FDC 50/500 μg b.i.d. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak FEV1 (L) Defined as the Highest Bronchodilatory Effect on FEV1 During a Period of 5 Min to 4 h After the Last Evening Dose of Each Treatment Period
The highest bronchodilator effect on FEV1 during a period of 5 min to 4 h after the last evening dose of each treatment period . To demonstrate superiority in peak bronchodilator effect of QVM149 at a dose of 150/50/160 μg o.d. and 150/50/80 μg o.d. compared to a FDC of salmeterol/fluticasone at a dose of 50/500 μg b.i.d. after 3 weeks of treatment in patients with asthma
Measured: 3 weeks
Secondary outcomes (5)
FEV1 Over 24 h After 21 Days of Treatment in Relation to Evening Dose
To evaluate the bronchodilator effect of each dose of QVM149 compared to salmeterol/fluticasone FDC after 3 weeks of treatment at -45 min, -15 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3h, 4 h, 8 h, 10 h, 11 h 55 min, 14 h, 18 h, 21 h, 23 h 15 min, 23 h 45 min.
Measured: -45 min, -15 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3h, 4 h, 8 h, 10 h, 11 h 55 min, 14 h, 18 h, 21 h, 23 h 15 min, 23 h 45 min at 3 weeks
FVC Over 24 h After 21 Days of Treatment in Relation to Evening Dose
To evaluate the bronchodilator effect of each dose of QVM149 compared to salmeterol/fluticasone FDC after 3 weeks of treatment at -45 min, -15 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3h, 4 h, 8 h, 10 h, 11 h 55 min, 14 h, 18 h, 21 h, 23 h 15 min, 23 h 45 min.
Measured: -45 min, -15 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3h, 4 h, 8 h, 10 h, 11 h 55 min, 14 h, 18 h, 21 h, 23 h 15 min, 23 h 45 min at 3 weeks
FEV1/FVC Ratio Over 24 h After 21 Days of Treatment in Relation to Evening Dose
To evaluate the bronchodilator effect of each dose of QVM149 compared to salmeterol/fluticasone FDC after 3 weeks of treatment at -45 min, -15 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3h, 4 h, 8 h, 10 h, 11 h 55 min, 14 h, 18 h, 21 h, 23 h 15 min, 23 h 45 min.
Measured: -45 min, -15 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3h, 4 h, 8 h, 10 h, 11 h 55 min, 14 h, 18 h, 21 h, 23 h 15 min, 23 h 45 min at 3 weeks
FEV1 AUC 5 Min - 1 h (Day 21) FEV1 AUC 5 Min - 4 h (Day 21) and FEV1 AUC 5 Min - 23 h 45 Min (Day 21)
To evaluate the bronchodilator effect of each dose of QVM149 compared to salmeterol/ fluticasone FDC by measuring standardized FEV1 AUCs after 3 weeks of treatment respective period.
Measured: 3 weeks
Trough FEV1 After 21 Days of Treatment
To evaluate post-dose trough bronchodilator effect of each dose of QVM149 compared to salmeterol/fluticasone FDC after 3 weeks of treatment in the respective treatment period. The trough FEV1 is the mean value of FEV1 at 23 h 15 min and 23 h 45 min post-dose
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start21 Jan 2017
- Primary completion2 Aug 2018
- Study completion2 Aug 2018
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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063086
- Sponsor's protocol ID
- CQVM149B2208
- Status last verified
- Sep 2021
- First submitted
- 21 Feb 2017
- Last updated
- 4 Oct 2021
- 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
Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
PubMed 36472162
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Double-dummy, Active-controlled, 3-period Complete Cross-over Study to Assess the Bronchodilator Effect and Safety of Two Doses of QVM149 Compared to a Fixed Dose Combination of Salmeterol/Fluticasone in Patients With Asthma
- ClinicalTrials.gov ID
- NCT03063086
- Acronym / sponsor ID
- CQVM149B2208
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 21 Jan 2017 (actual)
- Primary completion
- 2 Aug 2018 (actual)
- Study completion
- 2 Aug 2018 (actual)
- First posted
- 24 Feb 2017 (actual)
- Results
- Posted 13 Dec 2019
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 assess peak FEV1 of two doses of QVM149 compared to a fixed-dose combination of salmeterol/fluticasone (50/500μg b.i.d.) and to characterize the respective 24 hour bronchodilator effect profiles in patients with asthma. Data from this study will complement lung function data obtained in the pivotal QVM149 phase 3 program by assessing the bronchodilatory effect of QVM149 at multiple time-points over an entire dosing interval of 24 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Active comparator | Drug: QVM149 150/50/80 μg o.d., Drug: QVM149 150/50/160 μg o.d., Drug: salmeterol/fluticasone FDC 50/500 μg b.i.d.A-B-C |
| Sequence 2 | Active comparator | Drug: QVM149 150/50/80 μg o.d., Drug: QVM149 150/50/160 μg o.d., Drug: salmeterol/fluticasone FDC 50/500 μg b.i.d.A-C-B |
| Sequence 3 | Active comparator | Drug: QVM149 150/50/80 μg o.d., Drug: QVM149 150/50/160 μg o.d., Drug: salmeterol/fluticasone FDC 50/500 μg b.i.d.B-C-A |
| Sequence 4 | Active comparator | Drug: QVM149 150/50/80 μg o.d., Drug: QVM149 150/50/160 μg o.d., Drug: salmeterol/fluticasone FDC 50/500 μg b.i.d.B-A-C |
| Sequence 5 | Active comparator | Drug: QVM149 150/50/80 μg o.d., Drug: QVM149 150/50/160 μg o.d., Drug: salmeterol/fluticasone FDC 50/500 μg b.i.d.C-A-B |
| Sequence 6 | Active comparator | Drug: QVM149 150/50/80 μg o.d., Drug: QVM149 150/50/160 μg o.d., Drug: salmeterol/fluticasone FDC 50/500 μg b.i.d.C-B-A |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Male and female adult patients ≥ 18 years old and ≤ 75 years.
- Patients with a documented physician diagnosis of asthma for a period of at least 12 months prior to Visit 1 (Screening).
- Patients who have used ICS and LABA combinations for asthma for at least 3 month and at a stable medium or high dose of ICS for at least 1 month prior to Visit 1 (Screening).
- Pre-bronchodilator FEV1 of < 80 % of the predicted normal value at screening Visit 1 (spirometry will not be repeated at baseline prior to randomization).
- Patients who demonstrate an increase in FEV1 of ≥ 12 % and 200 mL after administration of 400 µg salbutamol/360 µg albuterol (or equivalent do se) at Visit 1 (Screening). All patients must perform a reversibility test at Visit 1 (Screening). If reversibility is not demonstrated at Visit 1 (Screening), then, reversibility testing may be repeated once during the screening period.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| QVM149 150/50/80 μg o.d.A | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| QVM149 150/50/160 μg o.d.B | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| salmeterol/fluticasone FDC 50/500 μg b.i.d.C | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
Primary outcome
Peak FEV1 (L) Defined as the Highest Bronchodilatory Effect on FEV1 During a Period of 5 Min to 4 h After the Last Evening Dose of Each Treatment Period
Time frame: 3 weeks
The highest bronchodilator effect on FEV1 during a period of 5 min to 4 h after the last evening dose of each treatment period . To demonstrate superiority in peak bronchodilator effect of QVM149 at a dose of 150/50/160 μg o.d. and 150/50/80 μg o.d. compared to a FDC of salmeterol/fluticasone at a dose of 50/500 μg b.i.d. after 3 weeks of treatment in patients with asthma
5 secondary outcomes
FEV1 Over 24 h After 21 Days of Treatment in Relation to Evening Dose
Time frame: -45 min, -15 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3h, 4 h, 8 h, 10 h, 11 h 55 min, 14 h, 18 h, 21 h, 23 h 15 min, 23 h 45 min at 3 weeks
FVC Over 24 h After 21 Days of Treatment in Relation to Evening Dose
Time frame: -45 min, -15 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3h, 4 h, 8 h, 10 h, 11 h 55 min, 14 h, 18 h, 21 h, 23 h 15 min, 23 h 45 min at 3 weeks
FEV1/FVC Ratio Over 24 h After 21 Days of Treatment in Relation to Evening Dose
Time frame: -45 min, -15 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3h, 4 h, 8 h, 10 h, 11 h 55 min, 14 h, 18 h, 21 h, 23 h 15 min, 23 h 45 min at 3 weeks
FEV1 AUC 5 Min - 1 h (Day 21) FEV1 AUC 5 Min - 4 h (Day 21) and FEV1 AUC 5 Min - 23 h 45 Min (Day 21)
Time frame: 3 weeks
Trough FEV1 After 21 Days of Treatment
Time frame: 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36472162Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
- A Plain Language Trial Summary is available on novartisclinicaltrials.comLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QVM149 150/50/80 μg o.d., QVM149 150/50/160 μg o.d. and salmeterol/fluticasone FDC 50/500 μg b.i.d. in people with Asthma, run by Novartis Pharmaceuticals at 12 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 0 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 4 Oct 2021. 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 Germany, China, Bulgaria, Netherlands, Romania and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 13 Dec 2019). 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?
Peak FEV1 (L) Defined as the Highest Bronchodilatory Effect on FEV1 During a Period of 5 Min to 4 h After the Last Evening Dose of Each Treatment Period (time frame: 3 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 NCT03063086, 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 4 Oct 2021.