Clinical trial to show equivalent efficacy and safety of fluticasone propionate (FP) delivered either through the Novolizer or through the Diskus in patients with moderate to severe asthma - Therapeutic equivalence study moderate to severe asthma

• Conditions: Classification code 10003553

• Registration Number: EUCTR2005-001730-32-CZ
• Lead Sponsor: VIATRIS GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-03
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

At enrolment

1. Male or female patients aged 18 to 75 years (inclusive)
2. Previously diagnosed bronchial asthma (for at least 6 months) of moderate to severe persistent intensity that required asthma pharmacotherapy over the 6 months preceding the study.
3. Pharmacotherapy of bronchial asthma in a stable dosage for the past 4 weeks with budesonide 400 - 1,600 micrograms/day or equivalent dose of another ICS.
4. FEV1 >= 50 % predicted
5. FEV1 reversibility of >= 15 % or 200 ml within 15 to 30 minutes following inhalation of 2 puffs of 100 micrograms salbutamol.

At randomisation:
6. Asthma stability during the last 2 weeks confirmed by:
- a current best FEV1 within +- 15 % of the best pre-dose FEV1 obtained at the previous visit,
- use of rescue medication (salbutamol) not more than 4 times a day (at maximum 8 actuations),
- no more than 2 night-time awakenings requiring salbutamol per week.
7. Adequate compliance (adequate completion of AM2+ assessments and administration of run-in medication to be checked by dose counter readings).
8. Pre-dose FEV1 >= 50 % predicted
9. Pre-dose FEV1 <= 80 % predicted, limited to group B patients who have been treated with a daily dose of 200 micrograms fluticasone throughout the run-in period only.

Are the trial subjects under 18?
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

Safety concerns:

1. Known hypersensitivity to FP, lactose or sympathomimetic drugs.
2. Pregnant or lactating female or female of child-bearing potential not employing adequate contraception.
3. History of life-threatening asthma.
4. Exacerbation of bronchial asthma requiring hospitalisation during the last 6 months prior to this study.
5. Patients suffering from clinically significant renal, endocrine, haematological, hepatic, immunological, gastrointestinal, neurological, psychiatric, coronary artery or other cardiovascular disease (excluding secondary symptoms of asthma, e.g. right ventricular hypertrophy).
6. patients suffering from cataract or glaucoma.

Lack of suitability for the trial:

7. Mild persistent asthma defined by FEV1 > 80 % predicted, treated with low dose ICS monotherapy of 400 - 600 micrograms budesonide per day (or equivalent dose of another ICS) and no use of additional LABA.
8. Patients suffering from occupational asthma.
9. Acute bacterial or fungal respiratory infection or diagnosis of active or inactive lung tuberculosis.
10. Subjects whose inhaled glucocorticosteroid dosage and/or other antiasthmatic controller therapy had to be changed within the last 4 weeks prior to the study start.
11. Use of systemic or depot glucocortocosteroids within the last 6 months
12. Exposure to any cytochrome P450 (CYP) 3A4 inhibiting drug (e.g. ritonavir, ketoconazole, erythromycin, rifampicin etc.) within 14 days prior to study enrolment, except for regular use of oral hormonal contraceptives.
13. Use of prohibited therapies as specified in chapter 6.3.1.1 of the study protocol
14. Neurological or psychiatric disease or therapy with anti-depressives or neuroleptics.
15. Malignant disease within the last 5 years.
16. Current smokers or smoking history > 10 pack-years (a pack-year is 20 cigarettes per day for one year).
17. Uncooperative patients not able to understand the instructions for use of inhalation devices or the electronic diaries.
18. Drug or alcohol abuse which would interfere with the subject´s proper completion of the protocol assignment.
19. Participation in another clinical study less than 2 months prior to or during this one.

Administrative reasons:

20. Lack of ability or willingness to give informed consent.
21. Anticipated non-availability for study visits/procedures.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To show therapeutic equivalence of 2 actuations of FP 100 micrograms BID delivered through the Diskus(R) and 2 actuations of FP 45 micrograms BID delivered through the Novolizer(R) (equivalent in terms of fine particle dose to nominal FP doses of 100 micrograms administered through the Diskus(R)) in patients with moderate to severe asthma.;Secondary Objective: To compare safety and tolerability of 2 actuations of FP 100 micrograms BID delivered through the Diskus(R) to that of 2 actuations of FP 45 micrograms BID delivered through the Novolizer(R).;Primary end point(s): Morning pre-dose FEV1 measurements obtained during visits (best of three readings fulfilling ATS criteria)