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
- Conditions
- -J45J45
- Registration Number
- PER-052-16
- Lead Sponsor
- OVARTIS BIOSCIENSES PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 64
1 Written informed consent.
2 Male and female adolescents aged ≥ 12 and ≤ 75 years old.
3 Documented diagnosis of asthma for a period of at least 3 months prior to Screening (Visit 1)
4 Use of low dose ICS, with or without controller at stable dose for at least 1 month prior to Screening (Visit 1)
5 Symptomatic at screening despite treatment with existing therapy. CQ-7 score ≥ 1.5 at Visit 101 and at Visit 102 (ie inadequately controlled).
6 Pre-bronchodilator FEV1≥ 60 % and < 90 % of the predicted normal value for the patient after withholding bronchodilators at both Visits 101 and 102.
7 Demonstrate an increase in FEV1 of ≥12% and ≥ 200 mL within 30 minutes after administration of 400 microgram salbutamol/360 microgram albuterol at Visit 101.
1Smoked or inhaled tobacco products.
2 Asthma attack/exacerbation.
3Intubation for a severe asthma attack/exacerbation.
4Clinical condition to be worsened by ICS.
5Respiratory tract infection or asthma worsening.
6Clinically significant oropharyngeal candidiasis.
7Chronic conditions affecting the upper respiratory tract.
8Chronic lung diseases other than asthma.
9Type I or II diabetes.
10Clinically significant laboratory abnormality.
11Use of investigational drugs.
12Clinically significant condition.
13History of myocardial infarction.
14Use of agents known to prolong the QTc interval.
15Long QT syndrome.
16Clinically significant ECG abnormality.
17Malignancy of any organ system.
18Hypersensitivity or intolerance to any of the study drugs.
19Rare hereditary problems of intolerance to milk products.
20Not achieved an acceptable spirometry results.
21Prohibited asthma-related.
22Prohibited medications.
23Narcolepsy and/or insomnia.
24Immunotherapy.
25Do not have a fixed residence or are detained.
26Directly associated with study team or their family.
27Unable to use Concept1, Twisthaler®, Accuhaler® or MDI.
28Alcohol or other substance abuse.
29Non-compliance to medication
30Do not maintain regular day/night cycles.
31 Pregnant or nursing women.
32 Women of child-bearing potential unless use of contraception.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method