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Assess Bronchodilator Effect and Safety of Two Doses of QVM149 Compared to a Fixed Dose Combination of Salmeterol/Fluticasone in Patients With Asthma.

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ClinicalTrials.gov Identifier: NCT03063086
Recruitment Status : Completed
First Posted : February 24, 2017
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Asthma 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. Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : January 21, 2017
Actual Primary Completion Date : August 2, 2018
Actual Study Completion Date : August 2, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Active Comparator: Sequence 1
A-B-C
Drug: QVM149 150/50/80 μg o.d.
A

Drug: QVM149 150/50/160 μg o.d.
B

Drug: salmeterol/fluticasone FDC 50/500 μg b.i.d.
C

Active Comparator: Sequence 2
A-C-B
Drug: QVM149 150/50/80 μg o.d.
A

Drug: QVM149 150/50/160 μg o.d.
B

Drug: salmeterol/fluticasone FDC 50/500 μg b.i.d.
C

Active Comparator: Sequence 3
B-C-A
Drug: QVM149 150/50/80 μg o.d.
A

Drug: QVM149 150/50/160 μg o.d.
B

Drug: salmeterol/fluticasone FDC 50/500 μg b.i.d.
C

Active Comparator: Sequence 4
B-A-C
Drug: QVM149 150/50/80 μg o.d.
A

Drug: QVM149 150/50/160 μg o.d.
B

Drug: salmeterol/fluticasone FDC 50/500 μg b.i.d.
C

Active Comparator: Sequence 5
C-A-B
Drug: QVM149 150/50/80 μg o.d.
A

Drug: QVM149 150/50/160 μg o.d.
B

Drug: salmeterol/fluticasone FDC 50/500 μg b.i.d.
C

Active Comparator: Sequence 6
C-B-A
Drug: QVM149 150/50/80 μg o.d.
A

Drug: QVM149 150/50/160 μg o.d.
B

Drug: salmeterol/fluticasone FDC 50/500 μg b.i.d.
C




Primary Outcome Measures :
  1. Peak FEV1 (mL) 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 ]
    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


Secondary Outcome Measures :
  1. FEV1, Forced Vital Capacity (FVC), and FEV1/FVC ratio at the following timepoints in relation to evening dose : [ Time Frame: 3 weeks ]
    To evaluate the bronchodilator effect of each dose of QVM149 compared to salmeterol/fluticasone FDC after 3 weeks of treatment.

  2. FEV1AUC 5 min - 1 h (Day 21) FEV1AUC 5 min - 4 h (Day 21) [ Time Frame: 3 weeks ]
    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.

  3. Trough FEV1 (mL; mean of FEV1 at 23 h 15 min and 23 h 45 min post-dose) [ Time Frame: 3 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion criteria

  • 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
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03063086


Locations
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Bulgaria
Novartis Investigative Site
Sofia, Bulgaria, 1612
China, Jilin
Novartis Investigative Site
Chang Chun, Jilin, China, 130021
China, Tianjin
Novartis Investigative Site
Tianjin, Tianjin, China, 300192
China
Novartis Investigative Site
Shanghai, China, 200433
Germany
Novartis Investigative Site
Berlin, Germany, 10117
Novartis Investigative Site
Frankfurt, Germany, 60596
Novartis Investigative Site
Grosshansdorf, Germany, 22947
Novartis Investigative Site
Hannover, Germany, 30625
Novartis Investigative Site
Wiesbaden, Germany, 65187
Netherlands
Novartis Investigative Site
Groningen, GZ, Netherlands, 9713
Romania
Novartis Investigative Site
Bucharest, Romania
United Kingdom
Novartis Investigative Site
Machester, United Kingdom, M23 9QZ
Sponsors and Collaborators
Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03063086     History of Changes
Other Study ID Numbers: CQVM149B2208
First Posted: February 24, 2017    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fluticasone
Salmeterol Xinafoate
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Bronchodilator Agents
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action