Assess Bronchodilator Effect and Safety of Two Doses of QVM149 Compared to a Fixed Dose Combination of Salmeterol/Fluticasone in Patients With Asthma.
NCT ID: NCT03063086
Last Updated: 2021-10-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
116 participants
INTERVENTIONAL
2017-01-21
2018-08-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Sequence 1
A-B-C
QVM149 150/50/80 μg o.d.
A
QVM149 150/50/160 μg o.d.
B
salmeterol/fluticasone FDC 50/500 μg b.i.d.
C
Sequence 2
A-C-B
QVM149 150/50/80 μg o.d.
A
QVM149 150/50/160 μg o.d.
B
salmeterol/fluticasone FDC 50/500 μg b.i.d.
C
Sequence 3
B-C-A
QVM149 150/50/80 μg o.d.
A
QVM149 150/50/160 μg o.d.
B
salmeterol/fluticasone FDC 50/500 μg b.i.d.
C
Sequence 4
B-A-C
QVM149 150/50/80 μg o.d.
A
QVM149 150/50/160 μg o.d.
B
salmeterol/fluticasone FDC 50/500 μg b.i.d.
C
Sequence 5
C-A-B
QVM149 150/50/80 μg o.d.
A
QVM149 150/50/160 μg o.d.
B
salmeterol/fluticasone FDC 50/500 μg b.i.d.
C
Sequence 6
C-B-A
QVM149 150/50/80 μg o.d.
A
QVM149 150/50/160 μg o.d.
B
salmeterol/fluticasone FDC 50/500 μg b.i.d.
C
Interventions
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QVM149 150/50/80 μg o.d.
A
QVM149 150/50/160 μg o.d.
B
salmeterol/fluticasone FDC 50/500 μg b.i.d.
C
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Novartis Investigative Site
Sofia, , Bulgaria
Novartis Investigative Site
Changchun, Jilin, China
Novartis Investigative Site
Tianjin, Tianjin Municipality, China
Novartis Investigative Site
Shanghai, , China
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Frankfurt, , Germany
Novartis Investigative Site
Großhansdorf, , Germany
Novartis Investigative Site
Hanover, , Germany
Novartis Investigative Site
Wiesbaden, , Germany
Novartis Investigative Site
Groningen, GZ, Netherlands
Novartis Investigative Site
Bucharest, , Romania
Novartis Investigative Site
Manchester, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Plain Language Trial Summary is available on novartisclinicaltrials.com
Other Identifiers
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CQVM149B2208
Identifier Type: -
Identifier Source: org_study_id
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