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 | 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 | 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 | University of the Philippines - 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 |
| University of the Philippines - 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
The following safety and tolerability endpoints will be evaluated:
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
20170424153546
2017-08-22
0000-00-00
35
11
Actual randomized are 11 patients in the study.
2017-08-22
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 :
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