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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 )

Tracking Information
First Submitted Date  ICMJE February 21, 2017
First Posted Date  ICMJE February 24, 2017
Last Update Posted Date March 28, 2019
Actual Study Start Date  ICMJE January 21, 2017
Actual Primary Completion Date August 2, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03063086 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2017)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assess Bronchodilator Effect and Safety of Two Doses of QVM149 Compared to a Fixed Dose Combination of Salmeterol/Fluticasone in Patients With Asthma.
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Sequence 1
    A-B-C
    Interventions:
    • 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.
  • Active Comparator: Sequence 2
    A-C-B
    Interventions:
    • 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.
  • Active Comparator: Sequence 3
    B-C-A
    Interventions:
    • 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.
  • Active Comparator: Sequence 4
    B-A-C
    Interventions:
    • 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.
  • Active Comparator: Sequence 5
    C-A-B
    Interventions:
    • 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.
  • Active Comparator: Sequence 6
    C-B-A
    Interventions:
    • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 27, 2019)
116
Original Estimated Enrollment  ICMJE
 (submitted: February 21, 2017)
114
Actual Study Completion Date  ICMJE August 2, 2018
Actual Primary Completion Date August 2, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   China,   Germany,   Netherlands,   Romania,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03063086
Other Study ID Numbers  ICMJE CQVM149B2208
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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

Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Novartis
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP