Safety and Efficacy of mometasone furoate delivered via Consept1 or Twisthaler® in adult and adolescent patients with persistent asthma
- Conditions
- AsthmaMedDRA version: 14.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2011-005100-14-LT
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 616
Patients with persistent asthma, diagnosed according to GINA 2010 guideline and who additionally meet the following criteria:
- Patients who are receiving ICS treatment
- Patients whose level of asthma control is Partly Controlled” or Uncontrolled”
- Patients with a pre-bronchodilator FEV1 value of = 80% of predicted normal value
- Patients who demonstrate an increase of >- 12% and 200 mL in FEV1
- Patients who are confirmed as ICS sensitive” by ACQ-5 questionnaire and FEV1.
*Other protocol defined inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 494
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 61
- Patients who are current smokers or have a smoking history of greater than 10 pack years (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked).
- Patients diagnosed with COPD as defined by the GOLD 2010 guidelines.
- Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest X-ray to be no longer active), or clinically significant bronchiectasis.
- Patients with any chronic conditions affecting the respiratory tract (e.g., chronic sinusitis) or chronic lung diseases, which in the opinion of the investigator may interfere with the study evaluation or optimal participation in the study.
*Other protocol-defined exclusion criteria may apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the non-inferiority of MF 80 µg and 320 µg delivered via Concept1 to MF 200 µg and 800 µg delivered via Twisthaler® in terms of 24 h post-dose trough FEV1 after 4 weeks treatment.;Secondary Objective: To evaluate the safety and tolerability of MF 80 µg and 320 µg delivered via Concept1, and MF 200 µg and 800 µg delivered via Twisthaler® over 4 weeks treatment: adverse events, laboratory analysis, vital signs (blood pressure and pulse rate) and ECG.;Primary end point(s): To demonstrate the non-inferiority of MF 80 µg and 320 µg delivered via Concept1 to MF 200 µg and 800 µg delivered via Twisthaler® in terms of 24 h post-dose trough FEV1 ;Timepoint(s) of evaluation of this end point: After 4 weeks of treatment
- Secondary Outcome Measures
Name Time Method Secondary end point(s): To evaluate the safety and tolerability of MF 80 µg and 320 µg delivered via Concept1, and MF 200 µg and 800 µg delivered via Twisthaler® in terms of adverse events, laboratory analysis, vital signs (blood pressure and pulse rate) and ECG;Timepoint(s) of evaluation of this end point: over 4 weeks of treatment