A 24-week, multicenter, multinational, randomized, double-blind, triple-dummy, 3-arm parallel group study comparing the efficacy and safety of CHF 1535 200/6 (beclomethasone dipropionate 200 µg plus formoterol 6 µg/actuation), 2 puffs b.i.d., versus beclomethasone diproprionate HFA (250 µg/actuation), 4 puffs b.i.d., versus Seretide® 500/50 (fluticasone 500 µg plus salmeterol 50 µg/actuation), 1 inhalation b.i.d., in patients with severe asthmaEstudio de 24 semanas de duración, multicéntrico, multinacional, aleatorizado, en doble ciego y con triple simulación, tres brazos y grupos paralelos, comparativo de la eficacia y la seguridad de CHF 1535 200/6 (beclometasona dipropionato 200 µg más formoterol 6 µg/aplicación), 2 disparos dos veces al día, frente a beclometasona dipropionato HFA (250 µg/aplicación), 4 disparos dos veces al día, frente a Seretide® 500/50 (fluticasona 500 µg más salmeterol 50 µg/aplicación), 1 inhalación dos veces al día, en pacientes con asma severa

Phase 1

• Conditions: Patient with severe asthmaAsma severa; MedDRA version: 9.1Level: LLTClassification code 10003553Term: Asthma

• Registration Number: EUCTR2007-002587-99-ES
• Lead Sponsor: CHIESI FARMACEUTICI S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-10-29
• Study Completion: 2009-09-10
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 721

Inclusion Criteria

Patient will be enrolled at Visit 1 into the run-in period if they meet each and every one of the following criteria:
1. Subject’s written informed consent and written informed consent by parents/legal
representatives (adolescent patients).
2. Outpatients of both sexes aged = 12 and = 70 years.
3. Evidence of asthma demonstrated by a documented positive response to the reversibility test, defined as ?FEV1 = 12% and = 200 mL over baseline, within 30 minutes after administration of 400 µg of salbutamol pMDI. In case this is not achieved, a historically documented FEV1 reversibility within the previous 12 months is acceptable.
4. Patients with severe persistent asthma diagnosed according to GINA guidelines (revised 2006).
5. Levels of asthma control, during each of the two previous weeks (to be checked at screening and at randomisation visits), defined as:
? 1 or more of the following:
- Daytime symptoms ? more than twice/ week;
- Limitations of activities ? any;
- Nocturnal symptoms/awakening ? any;
- Need for reliever/rescue treatment ? more than twice/ week.
6. Patients on previous treatment with high doses of ICS (> 1000 µg BDP CFC daily or equivalent) or ICS + LABA fixed or free combinations (daily dose of budesonide 800 µg/fluticasone 500 µg or equivalent ICS doses plus formoterol 24 µg or salmeterol 100µg) at a stable dose for at least 2 months prior to inclusion.
7. Patients who meet the following requirement: FEV1 = 40% and < 80% of predicted normal values and at least 0.9 L, after appropriate washout from bronchodilators.
8. A cooperative attitude and ability to be trained in the proper use of a pMDI, an
Accuhaler® and a portable electronic peak flow meter (SpirotelTM).
Are the trial subjects under 18? yes
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patient will not be enrolled at Visit 1 into the run-in period and will not be randomized to treatments at Visit 2 (i.e. these criteria will be also reviewed at Visit 2) if they meet one or more of the following criteria:
1. Pregnant or lactating women. Females of childbearing potential without an efficient contraception (e.g. oestro-progestatives, condoms).
2. Having received an investigational drug within 2 months.
3. Inability to comply with study procedures or with study treatment intake.
4. Seasonal asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer.
5. History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency, or any other significant lung disease.
6. Patients who suffer from COPD as diagnosed by the GOLD guidelines (2006).
7. Previous or current smokers who have a smoking history greater than 5 pack years, (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked).
8. Diagnosis of restrictive lung disease (e.g. kyphoscoliosis, ankylosing spondylitis).
9. Patients who have an uncontrolled cardiovascular (e.g., uncontrolled hypertension), respiratory, hematologic, immunologic, renal, neurologic, hepatic, endocrine (e.g., uncontrolled diabetes mellitus) or other disease, or any condition that might, in the judgment of the Investigator, place the patients at undue risk or potentially compromise the results or interpretation of the study.
10. Patients who have a history of coronary artery disease, cerebrovascular disease, and cardiac arrhythmias.
11. Patients who have a concomitant disease of poor prognosis (e.g., cancer).
12. Clinically relevant laboratory abnormalities such as (but not limited to hypokaliemia, that might compromise patient's safety or compliance, interfere with evaluation, or preclude completion of the study, in the judgment of the Investigator. Patients with uncontrolled diabetes including patients with a history of blood glucose levels consistently out of the normal range or HbA1C > 8.0% measured at Visit 1.
13. Patients who have an abnormal QTc interval value in the Screening visit ECG test (i.e., > 450 msec in males or > 470 msec in females).
14. Patients having received a live-attenuated virus vaccination within two weeks prior to screening or during the run-in.
15. Patients mentally or legally incapacitated.
16. Patients who abuse alcohol.
17. Intolerance/hypersensitivity or contra-indication to treatment with ß2-agonists and/or inhaled corticosteroids.
18. Major surgery in the previous 3 months.
19. Any change in dose, schedule, formulation or product of previous ICS or fixed/free combination ICS + LABAs in the 2 months prior to screening visit.
20. Any change in dose, schedule, formulation or product of other concomitant asthma treatments in the 2 months prior to screening visit.
21. Moderate/severe exacerbations and/or intake of oral corticosteroids during the 2-week run-in period.
22. Patients treated with slow-release corticosteroids in the 3 months prior to screening visit.
23. Patients treated with non-potassium sparing diuretics, beta-blocking drugs, quinidine, quinidine-like anti arrhythmics, or any medication with a QTc prolongation potential or a history of QTc prolongation.
24. Patients treated with monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants, unless already taken at stable doses at the screening visit.
25. Patients who are receiving therapy that could inte

Study & Design

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