Efficacy and safety of low dose QMF149 (150/80 microgram) compared with MF Twisthaler® in patients with asthma

Phase 1

• Conditions: Asthma; MedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2016-000472-22-EE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-27
• Last Update Posted: 26 November 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

-Patients with a documented diagnosis of asthma for a period of at least 3 months prior to Screening Visit
- Patients who have used low dose ICS , with or without controller (ie, LABA, Leukotriene Receptor Antagonist ) at stable dose for at least 1 month prior to Screening Visit
-Adult patients who are symptomatic at screening despite treatment with existing therapy.
Patients with ACQ-7 score = 1.5 at Visit 101 and at Visit 102 (inadequately
controlled).
- Adolescent patients :
If taking only ICS (without LABA) and are symptomatic at screening despite treatment with low doses of ICS. These patients must have ACQ-7 score = 1.5 at Visit 101
and at Visit 102 .
If taking ICS (low dose)/ LABA, and have ACQ-7 score =1 and <1.5 at Visit 101: they must have ACQ-7 score=1.5 at Visit 102 ( prior to randomization).
-Pre-bronchodilator FEV1= 60 % and < 90 % of the predicted normal value for the patient
after withholding bronchodilators at both Visits 101 and 102
-Patients who demonstrate an increase in FEV1 of = 12% and = 200 mL within 15 o 30 minutes after
administration of 400 microgram salbutamol/360 microgram albuterol (or equivalent dose) at Visit 101.

Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 850
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

• Patients who have smoked or inhaled tobacco products (including electronic cigarettes) within the 6 month period prior to Visit 1, or who have a smoking history of greater than or equal to 10 pack year.
• 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 Screening Visit. 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.
• Patients who ever required intubation for a severe asthma attack/exacerbation
• Patients with a clinical condition (eg. glaucoma, cataract and fragility fractures) which may be worsened by ICS administration (according to investigator's medical judgment )
• Patients who have had a respiratory tract infection or asthma worsening as determined by the investigator within 4 weeks prior to Screening Visit or between Visit 1and Visit 102. Patients may be re-screened 4 weeks after recovery from their respiratory tract infection or asthma worsening.
• Patients with any chronic conditions affecting the upper respiratory tract (eg. chronic sinusitis) which in the opinion of the investigator may interfere with the study.
• Patients with a history of chronic lung diseases other than asthma, including (but not limited to) COPD, sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis.
• Patients with Type I diabetes or uncontrolled Type II diabetes.
• Patients with narcolepsy and/or insomnia.
• Patients on Maintenance Immunotherapy (desensitization) for allergies or less than 3 months prior to Visit 101 or patients on Maintenance Immunotherapy for more than 3 months prior to Visit 101 but expected to change throughout the course of the study.
• Patients with diagnosed rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption or with known intolerance to lactose or milk products.
• Patients who use a long acting muscarinic antagonist (LAMA) within 3 months prior to Visit 1

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified