Safety and Efficacy of mometasone furoate delivered via Concept1 or Twisthaler® in adult and adolescent patients with persistent asthma

Phase 1

• Conditions: Asthma; MedDRA version: 14.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2011-005100-14-BE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-13
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 616

Inclusion Criteria

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? yes
Number of subjects for this age range: 61
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

Exclusion Criteria

- 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- Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest X-ray to be no longer active), or clinically significant bronchiectasis.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