Submitted by: Rachel Tayamora 2017-09-08 00:00:00 Last Updated by: Rachel Tayamora 2020-03-03 11:25:38


A multi-center, randomized, 12-week treatment, doubleblind study to assess the efficacy and safety of QMF149 (150/80 microgram) compared with MF Twisthaler® (200 microgram) in adult and adolescent patients with asthma  

PHRR170908-001687

CQVM149B2303

2017-CT0414

A multi-center, randomized, 12-week treatment, doubleblind study to assess the efficacy and safety of QMF149 (150/80 microgram) compared with MF Twisthaler® (200 microgram) in adult and adolescent patients with asthma

This study uses a 12-week treatment, randomized, double-blind, double-dummy, parallelgroup design. The 12 week treatment epoch will be followed by a 30 day follow up epoch . There is a screening visit (Visit 1) where informed consent is obtained and current asthma and other non-asthma medications are reviewed. Where appropriate, concurrent asthma and other medications are adjusted at this visit and prohibited asthma medications are replaced with permitted asthma medications for use throughout the study.

Regime Classification Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Start Date Duration in Months Target Completion Date Actual Completion Date
2017-08-22 16 2018-12-22 2019-01-11

Completed

Institution Classification Region LTO #
Novartis Healthcare Philippines, Inc. Private Business NCR CDRR-NCR-S-1
Institution Classification Region LTO #
PAREXEL Clinical Research (Philippines) Ltd. Corp. Private Business NCR
Institution Region
Novartis Healthcare Philippines, Inc. NCR
Name E-Mail Institution and Institution Address
Anna Liza Calingasin anna_liza.calingasin@novartis.com 2nd floor ARCC Bldg Salcedo corner Gamboa St Legaspi Village Makati City 1229
Name E-Mail Institution and Institution Address
Lawrence Allen Tria lawrence_allen.tria@novartis.com 2nd floor ARCC Bldg Salcedo corner Gamboa St Legaspi Village Makati City 1229
Name Expertise Affiliation
Dina V. Diaz, MD Pulmonology Lung Center of the Philippines
Jubert P. Benedicto, MD Pulmonology Philippine General Hospital, Section for Pulmonary Medicine
Malbar G. Ferrer, MD Pulmonology St. Paul's Hospital of Iloilo, Inc.
Project Location Institutional Ethics Review Board
Lung Center of the Philippines Lung Center of the Philippines Ethics Review Committee
Philippine General Hospital, Section for Pulmonary Medicine N/A
St. Paul's Hospital of Iloilo, Inc. St. Paul’s Hospital Iloilo – Institutional Ethics Review Board

asthma

The primary objective of this study is to demonstrate t he superiority of QMF149 150/80 microgram o.d. (in the evening) delivered via Concept1 compared with MF 200 microgram o.d. (in the evening) delivered via Twisthaler® in terms of trough FEV1 after 12 weeks of treatment in adults and adolescents.

 
 

The key secondary objective is to demonstrate the superiority of QMF149 150/80 microgram to MF 200 microgram o.d. in terms of ACQ-7 after 12 weeks of treatment.

Lung function:
 Trough FEV1 at Day 2 of treatment period (defined as the mean of 23 h15 min and 23 h 45min FEV1 values post dose of Day 1.)
 Pre-dose FEV1 (defined as the mean of -45 min and -15 min FEV1 values pre-evening dose) at 4 weeks
 Forced Vital Capacity (FVC) and Forced Expiratory Flow between 25% and 75% of FVC (FEF25-75) over 12 weeks
 Morning and Evening Peak Expiratory Flow Rate (PEF) over 4 and 12 weeks of treatment

 

Symptoms and asthma control:
 Percent of patients achieving the minimal important difference (MID) in ACQ-7 (i.e. at least 0.5 decrease from baseline) at Week 12
 Percentage of asthma symptoms free days, the percentage of nights without nighttime awakenings, and the percentage of mornings without symptoms on awakening as recorded
by daily electronic Diary (e-Diary) over 12 weeks of treatment
 Asthma control as assessed by the Asthma Control Questionnaire (ACQ-7) at Week 4
 Rescue salbutamol/albuterol usage (mean daily, nighttime and daytime use) from e-Diary
recordings over 12 weeks of treatment
 Percentage of rescue medication free days over 12 weeks of treatment period


Exacerbations:
 To evaluate the efficacy in terms of asthma exacerbation-related parameters described below during 12 weeks of treatment. The analysis will be performed by exacerbation category wherever specified. The exacerbation categories are: mild, moderate, severe and the combination of moderate or severe:
 Time to first asthma exacerbation by exacerbation category
 Time to first hospitalization for asthma exacerbation
 Annual rate of asthma exacerbations by exacerbation category
 Duration of asthma exacerbations in days by exacerbation category
 Percentage of patients with at least one asthma exacerbation by exacerbation category
 Total amounts (in doses) of systemic corticosteroids (SCS) used to treat asthma
exacerbations.
 Time in days to permanent discontinuation of study medication due to asthma
exacerbations
 Percentage of patients who permanently discontinued study medication due to asthma exacerbations
 Quality of life as assessed by Asthma Quality of Life Questionnaire (AQLQ) over 12 weeks of treatment period

The following safety and tolerability endpoints will be evaluated:
 Cumulative incidence of the composite endpoint of serious asthma outcomes (ie asthmarelated hospitalization, asthma-related intubation, or asthma-related death) over 12 weeks of treatment
 AEs, vital signs, electrocardiogram (ECG), and laboratory analysis (hematology, blood chemistry including glucose and potassium, urinalysis, evening plasma cortisol) over 12 weeks of treatment

Completed

  • India
  • Japan
  • Malaysia
  • Philippines
  • South Africa
  • South Korea
  • Thailand
  • Vietnam

Clinical Trial

CQVM149B2303

20170424153546

2017-08-22

0000-00-00

35

11

Actual randomized are 11 patients in the study.

22 Aug 2017

Adult patients with asthma who are symptomatic at screening despite treatment with existing therapy. Patients must have ACQ-7 score ≥ 1.5 at Visit 101 and at Visit 102 (ie, inadequately controlled) 

Adolescent patients with asthma :
 Patients taking low dose ICS (without LABA), who are symptomatic at screening despite treatment with low dose ICS. These patients must have ACQ-7 score ≥ 1.5 at Visit
101 and at Visit 102 (ie, inadequately controlled).
 Patients taking low dose ICS / LABA, may be included only if ACQ-7 score ≥1 and controlled). However ACQ-7 score must be ≥1.5 at Visit 102. Pre-dose FEV1 ≥ 60% and < 90% of the predicted normal value FEV1 reversibility ≥ 12% and ≥ 200 mL

Pregnant women/Nursing mothers
1. Women of child bearing potential (unless using adequate contraception)
2. History of chronic lung diseases other than asthma, including (but not limited to) chronic obstructive pulmonary disease, sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis.
3. Current smokers who smoked or inhaled tobacco products (including electronic cigarettes) within the 6 month period prior to visit 1 or exsmoker with ≥ 10 pack years smoking history.
4. Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization (> 24 hours) or emergency room visit (≤ 24 hours) as follows:
 For adults: within 6 weeks of Visit 1 (Screening). If patients experience an asthma attack/exacerbation requiring systemic steroids or emergency room visit between Visit 1 and Visit 102 they may be re-screened 6 weeks after recovery from the
exacerbation
 For adolescents: Exacerbation requiring systemic steroids, hospitalization (> 24 hours) or emergency room visit (≤ 24 hours) within 6 months prior to Visit 1.
5. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption or with known intolerance to lactose or milk products.

Interventional

QMF149 (indacaterol and mometasone furoate) and MF (mometasone furoate)

The Study drug is as follows:
 QMF149 (indacaterol acetate/MF) 150/80 microgram o.d. (in the evening) delivered as
powder in hard capsules via Concept1 inhaler
The Comparative treatment is:
 MF 200 microgram o.d. (in the evening) delivered as powder via Twisthaler®
In addition the following placebos will enable the double-dummy design of the study:
 Placebo delivered as powder via Twisthaler® (in the evening)
 Placebo delivered as powder in capsules via Concept1 (in the evening)

None

Randomized

Double Blind

Patients will be assigned to one of the following two treatment arms (as per randomization ratio of 1:1):  QMF149 150/80 microgram o.d. delivered via Concept1 (in the evening) and Placebo to MF 200 microgram o.d. delivered via a Twisthaler® (in the evening).  MF 200 microgram o.d. delivered via a Twisthaler® (in the evening) and Placebo to QMF149 150/80 microgram o.d. delivered via Concept1 (in the evening)

Parallel

The purpose of the trial is to evaluate efficacy and safety of QMF149 150/80 microgram o.d.
delivered via Concept1 compared to MF 200 microgram o.d., delivered via Twisthaler® in
terms of lung function and symptom control in poorly (ie inadequately) controlled asthma
patients. This study will assess contribution of LABA as an add-on therapy to low dose ICS
monotherapy.

Phase III

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