A study comparing whether the new drug comprising fluticasone propionate and salmeterol doses of 125µg and 25µg HFA MDI inhaler (spray pressure) applied two puffs twice daily is not less effective than the dose of 500µg / 50µg applied one puff twice daily as powder inhaler (DPI) in patients with asthma

Phase 1

• Conditions: Asthma is a common, chronic respiratory disease affecting 1–18% of the population in different countries. Asthma is characterized by variable symptoms of wheeze, shortness of breath, chest tightness and/or cough, and by variable expiratory airflow limitation. Both symptoms and airflow limitation characteristically vary over time and in intensity. These variations are often triggered by factors such as exercise, allergen or irritant exposure, change in weather, or viral respiratory infections.; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2017-000735-14-PL
• Lead Sponsor: ek-Am Sp. z o.o.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-20
• Study Completion: 2020-02-27
• Last Update Posted: 21 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 231

Inclusion Criteria

1. Male and female, age 18-70
2. Asthma diagnosed min 3 months before the screening visit. Therapy minimal requirement - GINA grade 4
3. FEV1 elevation by at least 12% and min. 200 ml after 400 µg of salbutamol application noted at the screening
4. FEV1 50-85% of predicted at the screening visit.

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 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1. Severe life threatening asthma or hospitalisation due to asthma exacerbation during 3 months before the screening
2. Uncontrolled or untreated significant immunology, endocrinology, hematology, psychiatric, neurology, hepatic, gastrointestinal disorders or neoplasma
3. Heart arythmia or other cardiovascular disorders, including hypertension with DBP = 95 mm Hg
4. Antibiotics taken during last 8 weeks before screening due to respiratory infection
5. Smoking >10 cigarettes/day

Study & Design

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