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Study to Compare the Pharmacokinetics of Mometasone Furoate Alone and in Combination With Indacaterol in Patients ≥ 6 to < 12 Years Old With Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04589663
Recruitment Status : Completed
First Posted : October 19, 2020
Last Update Posted : May 17, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This is an open-label, two-period, single-sequence crossover study including 2 single dose treatments of mometasone furoate 100 μg administered via Twisthaler® and of 75/40 µg indacaterol acetate/mometasone furoate fixed dose combination 75/40 µg (QMF149) administered via Concept 1 device with a washout period between the two treatments. The study will include a screening period of up to 14 days, two single-dose treatments separated by a 4-7 day washout period (4 days is the minimum washout) and a 30-day investigational drug-free follow-up period.

Condition or disease Intervention/treatment Phase
Asthma Drug: Mometasone furoate Drug: QMF149 Phase 2

Detailed Description:

This is an open-label, two-period, single-sequence, crossover study to assess the pharmacokinetics, safety and tolerability of single inhaled doses of mometasone furoate (MF) when administered alone via MF Twisthaler® (TH) or as an indacaterol acetate/MF fixed dose combination (QMF149) via the Concept 1 (C1) device in ≥ 6 to <12 year old asthma patients. The study includes two open-label single-dose treatment visits. On the first treatment visit (Day 1) patients receive a single inhaled dose of 100 μg MF administered via the Twisthaler® device. On the second treatment visit (Day 6) patients receive a single inhaled dose of 75/40 μg indacaterol acetate/MF fixed dose combination (QMF149) via C1 device. Both treatments are in addition to their rescue medication and potentially standard of care asthma therapy (excluding MF and indacaterol acetate).

The primary objective is to compare the systemic exposure to MF resulting from single doses of MF when administered as MF TH 100 μg versus QMF149 75/40 μg C1.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Masking Description: Open label
Primary Purpose: Treatment
Official Title: An Open-label, Two-period, Single-sequence, Crossover Study to Compare the Systemic Exposure of a Single Inhaled Dose of Mometasone Furoate (MF) When Administered Alone Via the MF Twisthaler® (TH) to a Single Inhaled Dose of QMF149 Indacaterol Acetate/MF Fixed Dose Combination When Administered Via the Concept 1 (Breezhaler®) Device in ≥ 6 to <12 Year Old Asthma Patients
Actual Study Start Date : June 7, 2021
Actual Primary Completion Date : April 11, 2022
Actual Study Completion Date : April 11, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Mometasone furoate followed by QMF149
Single inhaled dose of mometasone furoate on Day 1 followed by a single inhaled dose of QMF149 on Day 6
Drug: Mometasone furoate
Single inhaled dose of 100 µg mometasone furoate (MF) administered via Twisthaler® on Day 1

Drug: QMF149
Single inhaled dose of QMF149 (75/40 µg indacaterol acetate/MF fixed dose combination) administered via Concept 1 device on Day 6




Primary Outcome Measures :
  1. Maximum observed mometasone furoate plasma concentration (Cmax) [ Time Frame: pre-dose, 0.5, 1, 2, 3 and 6 hours post-dose on Day 1 and Day 6 ]
    Mometasone furoate plasma concentrations will be determined by a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) method. Cmax of mometasone furoate will be determined with Phoenix WinNonlin (Version 6.4 or higher).

  2. Area under the plasma concentration-time curve from time zero to the last sampling time point 6h (AUC0-6h) of mometasone furoate [ Time Frame: pre-dose, 0.5, 1, 2, 3 and 6 hours post-dose on Day 1 and Day 6 ]
    AUC0-6h of mometasone furoate will be determined using non-compartment methods with Phoenix WinNonlin (Version 6.4 or higher). The linear trapezoidal rule will be used for AUC0-6h calculation.


Secondary Outcome Measures :
  1. Systemic exposure to indacaterol in plasma [ Time Frame: pre-dose, 0.25 and 1 hour post-dose on Day 6 ]
    Systemic exposure to indacaterol in plasma following sparse pharmacokinetic (PK) sampling on Day 6 after inhalation of QMF149.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female children ≥ 6 years and < 12 years at the time of study entry.
  2. Written informed consent by parent(s)/legal guardian(s) for the pediatric patient and assent by the pediatric patient (depending on local requirements) must be obtained before any study-specific assessment is performed.
  3. Confirmed documented diagnosis of asthma, as defined by national or international asthma guidelines for at least 6 months prior to study enrollment.
  4. Patients using low dose ICS as asthma controller therapy for at least 4 weeks prior to first treatment.
  5. Patients who are familiar with the use of an inhaler device.
  6. Patients must be able to comply with the Study Visit Assessment Schedule which includes approximately 7 hours on two occasions, and agree to blood draws as scheduled.
  7. Parents/ legal guardian must be willing and able to attend study visits and assist the child with the procedures outlined in the protocol

Exclusion Criteria:

  1. Use of other investigational drugs within 5 half-lives of enrollment, or [within 30 days (for small molecules) /until the expected PD effect has returned to baseline (for biologics)], whichever is longer.
  2. Patients with weight < 17kg at screening.
  3. Patients currently taking MF products for any reason at least 7 days prior to Day 1. Patients can enroll if MF was discontinued at least 7 days prior to Day 1 and MF is substituted with a different steroid during entire study duration to avoid its potential impact on PK assessment. These MF products include inhalation, topical and/or nasal spray formulations.
  4. Patients on medium- and high- dose ICS or any dose ICS/LABA combination.
  5. Patients taking maintenance controller therapy (eg LABAs and theophylline) within 4 weeks of screening or during the study. LTRAs are permitted provided that patients have been on a stable dose for 4 weeks prior to screening. Patients using short-acting bronchodilators on occasional basis as rescue medication can enroll, however, these medications must be withheld at least 8 hours prior to study dosing visits and during PK sampling.
  6. Contraindicated for treatment with, or having a history of reactions/hypersensitivity to any of the following inhaled drugs, drugs of a similar class, or any component there of:

    • Adrenoreceptor agonist agent Lactose or any of the other excipients of the study drug (including patients with history of galactose intolerance, lactase deficiency or glucose-galactose malabsorption)
    • Corticosteroids
    • Indacaterol and/or MF
  7. History of chronic lung disease other than asthma within 3 months of first treatment visit (Day 1), cystic fibrosis, mycobacterial or other infection (including active SARS-CoV-2, tuberculosis or atypical mycobacterial disease).
  8. History of active bacterial, viral or fungal infection (including SARS-CoV-2) within 6 weeks of first treatment visit (Day 1).
  9. Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 6 weeks of first treatment visit (Day 1).
  10. Patients who, in the opinion of the investigator, are not able to comply with study treatment or who have any medical or mental disorder, situation, or diagnosis, which could interfere with the proper completion of the study protocol requirements or pose a safety risk while participating in the study.
  11. Parent/guardian has a history of psychiatric disease, intellectual deficiency, substance abuse, or other condition (e.g. inability to read, comprehend and write) which will limit the validity of consent for their child to participate in this study.
  12. Hemoglobin levels outside normal ranges at screening.
  13. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the patient in case of participation in the study.
  14. Patients who have a clinically significant ECG abnormality or clinically significant abnormal lab values reported at Screening Visit.
  15. Patients with a history of long QT syndrome or whose corrected QT interval (QTc) measured at Screening Visit (Fridericia method) is prolonged (≥ 450 msec for males and females 6 - 12 years old).
  16. Use of any prescription drugs, herbal supplements, prescribed medicinal use of cannabis/marijuana, within four weeks prior to initial dosing, and/or over-the-counter (OTC) medication, dietary supplements within two weeks prior to initial dosing. If needed, (i.e. an incidental and limited need) paracetamol/acetaminophen is acceptable, but must be documented in the Concomitant medications / Significant non-drug therapies page of the CRF.
  17. History of malignancy of any organ system, treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
  18. Patient is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.
  19. Pregnant or nursing (lactating) females.
  20. Inability to properly train in the use of the In-Check DIAL® at screening (at the investigator's discretion).
  21. Inability to properly train in the use of the Twisthaler® or Concept 1 Breezhaler® prior to dosing (at the investigator's discretion).
  22. History of paradoxical bronchospasm in response to inhaled medicines.
  23. Patients receiving any medications in the classes specified in protocol Table 6-2 unless they undergo the required washout period prior to Day 1.
  24. Patients who are sexually active.

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): NCT04589663


Locations
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Hungary
Novartis Investigative Site
Nagykanizsa, Hungary, 8800
South Africa
Novartis Investigative Site
George, Western Cape, South Africa, 6529
Novartis Investigative Site
Cape Town, South Africa, 7531
Sponsors and Collaborators
Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04589663    
Other Study ID Numbers: CQMF149G2203
2020-002036-78 ( EudraCT Number )
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: May 17, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
QMF149
mometasone furoate
indacaterol
pediatric
asthma
PK
Additional relevant MeSH terms:
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Mometasone Furoate
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents