AsthmaPhase 2QVM149NCT03108027

Assess Bronchodilator Effect QVM149 Dosed Either in the Morning or Evening Compared to Placebo in Patients With Asthma

A Phase 2 study of Asthma, run by Novartis Pharmaceuticals at 7 sites in 3 countries.

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Asthma
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 38 participants
Where: 7 sitesin 3 countries
Study dates: 26 Jun 2017to 24 Feb 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with a documented physician diagnosis of asthma and who additionally meet the following criteria:
Patients receiving daily treatment with an inhaled corticosteroid at a low or medium daily dose
On a stable regimen for at least 4 weeks prior to screening.
Pre-bronchodilator FEV1 ≥ 60 % and < 100% of the predicted normal value for the patient during screening.
Patients who demonstrate an increase in FEV1 of ≥ 12 % and ≥ 200 mL after administration of 400 μg salbutamol/360 μg albuterol (or equivalent dose) at Screening. All patients must perform a reversibility test at Screening.
At screening, and baseline (day 1 pre-dose time) of the first treatment period, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position and again in the standing position as outlined in the SOM. Sitting and standing vital signs should be within the following ranges:

Show all 12Show fewer

oral body temperature between 35.0-37.5 °C
systolic blood pressure, 90-159 mmHg
diastolic blood pressure, 50-99 mmHg
pulse rate, 40-90 bpm
Hypertensive patients must have been on stable antihypertensive therapy for at least 4 weeks prior to screening to be included in the trial.
Patients must weigh at least 50 kg at screening to participate in the study, and must have a body mass index (BMI) within the range of 18 to 40 kg/m2.

Who cannot join

Contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the drugs of a similar class
Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 1 year of Screening.
Patients who have had previous intubation for a severe asthma ttack/exacerbation.
Patients with a history of clinically relevant bronchoconstriction upon repeated forced expiratory maneuvers.
History of paradoxical bronchospasm in response to inhaled medicines.
Patients who during the run-in period prior to randomization require the use of ≥12 puffs / 24 hours of rescue medication for 48 hours (over two consecutive days) or who have a decline in PEF from the reference PEFof ≥ 30% for 6 consecutive scheduled PEF readings
Patients who do not maintain regular day/night, waking/sleeping cycles (e.g., night shift workers).

Trial locations and contacts

7 sites in 3 countries.

Country

City, postcode or hospital

7 sites in 3 countries

Germany5 sites

Novartis Investigative Site
Berlin, 10117
Novartis Investigative Site
Frankfurt Am Main Hessen, 60596
Novartis Investigative Site
Großhansdorf, 22947
Novartis Investigative Site
Hanover, 30625
Novartis Investigative Site
Wiesbaden, 65187

Other trials in Germany

Netherlands1 site

Novartis Investigative Site
Groningen, GZ, 9713

Other trials in Netherlands

United Kingdom1 site

Novartis Investigative Site
Machester, M23 9QZ

Other trials in United Kingdom

About this study

Official title: A Randomized, Double-blind, Repeat Dose Cross-over Study to Assess the Bronchodilator Effects of Once Daily QVM149 Following Morning or Evening Dosing for 14 Days Compared to Placebo in Patients With Asthma

This was a randomized, placebo-controlled, double-blind, six-sequence, three-period cross-over study in asthma patients. The study consisted of a 14-day screening period, followed by a 14-day run-in period, and a treatment epoch which consists of three treatment periods, with a minimum duration of 14 days each followed (for the 2 first treatment periods) by a wash-out period. The duration of each treatment period may be extended up to a duration of 18 days if needed for operational reasons. The third treatment period was followed by a Study Completion evaluation at 1-7 days following the last dose. The treatment periods were separated by wash-out periods of 14 to 21 days duration.

Conditions: Asthma
Being tested: Treatment A: Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose), Treatment B: QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose), Treatment C: Placebo (morning dose) and placebo (evening dose)
Keywords: QVM149,, asthma,, allergic asthma,, allergy triggered asthma,, reactive asthma,, asthma attack,, difficulty breathing
Medical subject headings: Asthma, Dyspnea

What participants receive

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

Treatment A: Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose)Drug
Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose)
Treatment B: QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose)Drug
QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose)
Treatment C: Placebo (morning dose) and placebo (evening dose)Drug
Placebo (morning dose) and placebo (evening dose)

Study groups in NCT03108027
Study group	Role	What they receive
Sequence 1	Experimental	Patients will receive in a sequential order the following interventional treatments: A,B and C. Receives: Drug: Treatment A: Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose); Drug: Treatment B: QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose); Drug: Treatment C: Placebo (morning dose) and placebo (evening dose)
Sequence 2	Experimental	Patients will receive in a sequential order the following interventional treatments: B, A and C. Receives: Drug: Treatment A: Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose); Drug: Treatment B: QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose); Drug: Treatment C: Placebo (morning dose) and placebo (evening dose)
Sequence 3	Experimental	Patients will receive in a sequential order the following interventional treatments: C, B and A. Receives: Drug: Treatment A: Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose); Drug: Treatment B: QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose); Drug: Treatment C: Placebo (morning dose) and placebo (evening dose)
Sequence 4	Experimental	Patients will receive in a sequential order the following interventional treatments : C, A and B. Receives: Drug: Treatment A: Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose); Drug: Treatment B: QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose); Drug: Treatment C: Placebo (morning dose) and placebo (evening dose)
Sequence 5	Experimental	Patients will receive in a sequential order the following interventional treatments: A, C and B. Receives: Drug: Treatment A: Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose); Drug: Treatment B: QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose); Drug: Treatment C: Placebo (morning dose) and placebo (evening dose)
Sequence 6	Experimental	Patients will receive in a sequential order the following interventional treatments: B, C and A. Receives: Drug: Treatment A: Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose); Drug: Treatment B: QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose); Drug: Treatment C: Placebo (morning dose) and placebo (evening dose)

What is being measured

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

FEV1 Standardized Area Under the Curve (AUC 0-24h) After Last Evening Dose of 14-day Treatment Period
Weighted mean forced expiratory volume in 1 second (FEV1) over 24 h (AUC0-24h) following 14 days of treatment with QVM149 dosed in the morning, QVM149 dosed in the evening and placebo.
Measured: At the end of each treatment period day 14 pre-dose to 24 hours post-dose.

Secondary outcomes (2)

Trough FEV1 After 24h
FEV1 at approximately 24 h after the last p.m. or penultimate a.m. dose. Morning and evening trough FEV1 (L) were analyzed by time of day. For morning trough FEV1 (L) assessments this meant that the spirometric assessment was done approximately 24 h after last morning dose and approximately 12 h after last evening dose.
Measured: At the end of each treatment period day 14 pre-dose to 24 hours post-dose.
Peak Expiratory Flow (PEF)
Peak expiratory flow (PEF) is the maximum flow generated during a forceful exhalation, starting from full lung inflationDaily morning and evening peak expiratory flow rate from Day 2 to Day14 during the three treatment periods.
Measured: From treatment period start through study completion (up to 19 weeks).

Timeline

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

26 Jun 201724 Feb 2018

First posted11 Apr 2017
Study start26 Jun 2017
Primary completion24 Feb 2018
Study completion24 Feb 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.
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
Model description: This study is to assess the bronchodilator effects of QVM149 dosed once daily either in the morning or in the evening for 2 weeks compared to placebo. It will provide evidence of the comparability of lung function effects of QVM149 irrespective of the administration schedule
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03108027
Sponsor's protocol ID: CQVM149B2209
Other IDs: 2017-000644-17, 2017
Acronym: QVM149
Status last verified: May 2019
First submitted: 23 Mar 2017
Last updated: 5 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Repeat Dose Cross-over Study to Assess the Bronchodilator Effects of Once Daily QVM149 Following Morning or Evening Dosing for 14 Days Compared to Placebo in Patients With Asthma
ClinicalTrials.gov ID: NCT03108027
Acronym / sponsor ID: QVM149 / CQVM149B2209
Conditions: Asthma
Keywords: QVM149,, asthma,, allergic asthma,, allergy triggered asthma,, reactive asthma,, asthma attack,, difficulty breathing
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 26 Jun 2017 (actual)
Primary completion: 24 Feb 2018 (actual)
Study completion: 24 Feb 2018 (actual)
First posted: 11 Apr 2017 (actual)
Results: Posted 21 May 2019

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6
Model description: This study is to assess the bronchodilator effects of QVM149 dosed once daily either in the morning or in the evening for 2 weeks compared to placebo. It will provide evidence of the comparability of lung function effects of QVM149 irrespective of the administration schedule

Arm	Type	Receives
Sequence 1	Experimental	Drug: Treatment A: Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose), Drug: Treatment B: QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose), Drug: Treatment C: Placebo (morning dose) and placebo (evening dose)Patients will receive in a sequential order the following interventional treatments: A,B and C.
Sequence 2	Experimental	Drug: Treatment A: Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose), Drug: Treatment B: QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose), Drug: Treatment C: Placebo (morning dose) and placebo (evening dose)Patients will receive in a sequential order the following interventional treatments: B, A and C.
Sequence 3	Experimental	Drug: Treatment A: Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose), Drug: Treatment B: QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose), Drug: Treatment C: Placebo (morning dose) and placebo (evening dose)Patients will receive in a sequential order the following interventional treatments: C, B and A.
Sequence 4	Experimental	Drug: Treatment A: Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose), Drug: Treatment B: QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose), Drug: Treatment C: Placebo (morning dose) and placebo (evening dose)Patients will receive in a sequential order the following interventional treatments : C, A and B.
Sequence 5	Experimental	Drug: Treatment A: Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose), Drug: Treatment B: QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose), Drug: Treatment C: Placebo (morning dose) and placebo (evening dose)Patients will receive in a sequential order the following interventional treatments: A, C and B.
Sequence 6	Experimental	Drug: Treatment A: Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose), Drug: Treatment B: QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose), Drug: Treatment C: Placebo (morning dose) and placebo (evening dose)Patients will receive in a sequential order the following interventional treatments: B, C and A.

Who may qualify

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

Key inclusion criteria (12 listed)

Patients with a documented physician diagnosis of asthma and who additionally meet the following criteria:
Patients receiving daily treatment with an inhaled corticosteroid at a low or medium daily dose
On a stable regimen for at least 4 weeks prior to screening.
Pre-bronchodilator FEV1 ≥ 60 % and < 100% of the predicted normal value for the patient during screening.
Patients who demonstrate an increase in FEV1 of ≥ 12 % and ≥ 200 mL after administration of 400 μg salbutamol/360 μg albuterol (or equivalent dose) at Screening. All patients must perform a reversibility test at Screening.

Key exclusion criteria (7 listed)

Contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the drugs of a similar class
Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 1 year of Screening.
Patients who have had previous intubation for a severe asthma ttack/exacerbation.
Patients with a history of clinically relevant bronchoconstriction upon repeated forced expiratory maneuvers.
History of paradoxical bronchospasm in response to inhaled medicines.

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
Treatment A: Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose)Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose)	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6
Treatment B: QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose)QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose)	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6
Treatment C: Placebo (morning dose) and placebo (evening dose)Placebo (morning dose) and placebo (evening dose)	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6

Primary outcome

FEV1 Standardized Area Under the Curve (AUC 0-24h) After Last Evening Dose of 14-day Treatment Period
Time frame: At the end of each treatment period day 14 pre-dose to 24 hours post-dose.
Weighted mean forced expiratory volume in 1 second (FEV1) over 24 h (AUC0-24h) following 14 days of treatment with QVM149 dosed in the morning, QVM149 dosed in the evening and placebo.

2 secondary outcomes

Trough FEV1 After 24h
Time frame: At the end of each treatment period day 14 pre-dose to 24 hours post-dose.
Peak Expiratory Flow (PEF)
Time frame: From treatment period start through study completion (up to 19 weeks).

Results and safety

Results posted to the registry on 21 May 2019, 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 1	7	7
Sequence 2	6	6
Sequence 3	6	6
Sequence 4	6	4
Sequence 5	6	6
Sequence 6	6	6

Primary outcome: FEV1 Standardized Area Under the Curve (AUC 0-24h) After Last Evening Dose of 14-day Treatment Period

Time frame: At the end of each treatment period day 14 pre-dose to 24 hours post-dose.. Least squares mean (Standard Error). Unit: Liters

Measure	QVM149 am n = 30	QVM149 pm n = 30	Placebo n = 33
Value	3.4305 (0.15242)	3.4361 (0.15213)	2.8209 (0.15259)

QVM149 am vs Placebo: Mean Difference (Net): 0.6096 (90% CI 0.5380 to 0.6811), Mixed Models Analysis
QVM149 pm vs Placebo: Mean Difference (Net): 0.6152 (90% CI 0.5437 to 0.6868), Mixed Models Analysis
QVM149 am vs QVM149 pm: Mean Difference (Net): -0.0057 (90% CI -0.0760 to 0.0647), Mixed Models Analysis

Population analysed: The pharmacodynamic (PD) analysis set included all patients with any available PD data, who received any dose of study drug and experienced no protocol deviations with relevant impact on PD data.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 19 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
QVM149 a.m.	0 of 35 (0%)	11 of 35 (31.4%)	0 of 35
QVM149 p.m.	0 of 35 (0%)	13 of 35 (37.1%)	0 of 35
Placebo	0 of 36 (0%)	16 of 36 (44.4%)	0 of 36

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
A Plain Language Trial Summary is available on novartisclinicatrials.comLink provided by the sponsor.
Individual participant dataSharing planned: No

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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.

7 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study of Asthma, run by Novartis Pharmaceuticals at 7 sites in 3 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 12 inclusion and 7 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 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Germany, Netherlands, United Kingdom. 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 21 May 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?

FEV1 Standardized Area Under the Curve (AUC 0-24h) After Last Evening Dose of 14-day Treatment Period (time frame: At the end of each treatment period day 14 pre-dose to 24 hours post-dose.). 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 NCT03108027.

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 5 Jan 2021.