Study of safety of Foradil in patients with persistent asthma.

Recruitment status:
Not Recruiting
Primary Sponsor:
Novartis Pharma services AG
Recruitment countries:
Argentina,  Australia,  Brazil,  Bulgaria,  Canada,  Chile,  Colombia,  Czech Republic,  Denmark,  Estonia,  European Union,  Finland,  France,  Germany,  Greece,  Hungary,  India,  Indonesia,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Mexico,  New Zealand,  Panama,  Philippines,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Singapore,  Slovakia,  South Africa,  Spain,  Sweden,  Taiwan,  Thailand,  Turkey,  Ukraine,  United Kingdom,  United States,  Vietnam
Health condition studied:
Persistent asthma
MedDRA version: 18.0 Level: SOC Classification code 10038738 Term: Respiratory, thoracic and mediastinal disorders System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
URL:
Link to the clinical trial website

About the trial

Interventions:

Trade Name: Foradil (formoterol fumarate)
Product Name: Foradil 12mcg
Product Code: FOR258
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Formoterol Fumarate dihydrate
CAS Number: 43229-80-7
Current Sponsor code: FOR258
Other descriptive name: FORMOTEROL FUMARATE
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 12-
Pharmaceutical form of the placebo: Inhalation powder, hard capsule
Route of administration of the placebo: Inhalation use

Trade Name: Flutide® Diskus®
Product Name: Flutide® mite 100 Diskus®
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: fluticasone propionate
CAS Number: 80474-14-2
Other descriptive name: FLUTICASONE PROPIONATE
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 100-

Trade Name: Flutide® Diskus®
Product Name: Flutide® 250 Diskus®
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: fluticasone propionate
CAS Number: 80474-14-2
Other descriptive name: FLUTICASONE PROPIONATE
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 250-

Trade Name: Flutide® Diskus®
Product Name: Flutide® 500 Diskus®
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: fluticasone propionate
CAS Number: 80474-14-2
Other descriptive name: FLUTICASONE PROPIONATE
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 500-

Key inclusion and exclusion criteria:
  • Inclusion criteria:
    Patients eligible for inclusion in this study must fulfill all of the following criteria:
    • Written informed consent, and assent if applicable, must be obtained before any assessment is performed.
    • Male or female patients 12 years of age and older
    • Confirmed diagnosis of persistent asthma, as defined by national and international asthma guidelines (e.g., GINA; NIH; etc.) for at least 1 year prior to study enrollment.
    • PEF=50% of predicted normal value.
    • Current and appropriate use of treatments for asthma
    • Recent asthma exacerbation between 30 days and 12 months prior to randomization
























    Are the trial subjects under 18? yes
    Number of subjects for this age range: 1200
    F.1.2 Adults (18-64 years) yes
    F.1.2.1 Number of subjects for this age range 9300
    F.1.3 Elderly (>=65 years) yes
    F.1.3.1 Number of subjects for this age range 1200
  • Exclusion criteria:
    Patients fulfilling any of the following criteria are not eligible for
    inclusion in this study:
    • History of life-threatening asthma episode that required intubation and/or was associated with hypercapnia requiring non-invasive ventilatory support.
    • Current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, allergic bronchopulmonary aspergillosis, cystic fibrosis, bronchopulmonary dysplasia, or other respiratory abnormalities other than asthma.
    • Current evidence of, or past physician assessment of, chronic bronchitis, emphysema, or chronic obstructive pulmonary disease.
    • History of smoking = 10 pack years.
    • Exercise induced asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine.
    • Worsening/Unstable asthma within 7 days prior to randomization,
    • Any asthma exacerbation requiring systemic (tablets, suspension or injection) corticosteroids within 30 days of randomization or more than 4 separate exacerbations in the 12 months preceding randomization.
    • Two or more hospitalizations greater than 24 hours duration for treatment of asthma in the 12 months preceding randomization.
    • Use of anti-IgE (e.g., omalizumab) or any other monoclonal antibody, in the 6 months prior to randomization.
  • Age minimum: 
  • Age maximum: 
  • Gender: 
    Female: yes
    Male: yes
Primary outcomes:
Main Objective: To demonstrate that the addition of FOM to FP therapy is non-inferior to FP therapy alone in terms of the risk of composite serious asthma related events (asthma-related hospitalization, asthma-related intubation, and asthma-related death).
Primary end point(s): To demonstrate that the addition of FOM to FP therapy is non-inferior to FP therapy alone in terms of the risk of composite serious asthma related events (asthma-related hospitalization, asthma-related intubation, and asthma-related death).
Secondary Objective: • to assess the safety each of the individual components of the composite primary endpoint (i.e., asthma-related hospitalization, asthma-related intubation, and asthmarelated
death).
• To assess the efficacy of FOM.

Timepoint(s) of evaluation of this end point: Throughout the 26 week treatment period (182 days) + 7 days of follow up period.
Secondary outcomes:
Secondary end point(s): • To assess the safety each of the individual components of the composite primary endpoint (i.e., asthma-related hospitalization, asthma-related intubation, and asthma related
death).
• To assess the efficacy of FOM.

Timepoint(s) of evaluation of this end point: Throughout the 26 week treatment period (182 days) + 7 days of follow up period.
Target sample size:
11700
Study type:
Interventional clinical trial of medicinal product
Study design:
Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
Contacts:
  • Name: Elena Kovalenko 
  • Address:  Lichtstrasse 35
  • Phone:  0041613244124
  • Email:  elena.kovalenko@novartis.com
  • Affiliation:  Novartis Pharma services AG

Technical details

Scientific title:
A 26 week, randomized, active-controlled safety study of double-blind formoterol fumarate in free combination with an inhaled corticosteroid versus an inhaled corticosteroid in adolescent and adult patients with persistent asthma
Sources of monetary support:
Novartis Pharma AG
Secondary sponsors:
Main ID:
EUCTR2012-004854-27-HU
Secondary ID:
2012-004854-27-LT
NCT01845025
CFOR258D2416
Register:
EU Clinical Trials Register
Date of registration:
28/05/2015
Date of first enrollment:
10/08/2015
Last refreshed:
7 December 2015

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