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

• Conditions: mild to moderate persistent asthma; Classification code 10003553

• Registration Number: EUCTR2005-001729-26-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: 500

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 mild to moderate persistent intensity, baseline FEV1 > 60 % and <= 85 % of the value predicted for the patient´s age, height and sex.
3. FEV1 reversibility of >= 15 % or 200 ml within 15 to 30 minutes following inhalation of 2 puffs of 100 micrograms salbutamol.
at randomisation:
4. Best FEV1 at visit V2 within +- 15 % of the best FEV1 obtained at screening (V1).
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
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 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).

Lack of suitability for the trial:

6. Patients suffering from occupational asthma.
7. Acute bacterial or fungal respiratory infection or diagnosis of active or inactive lung tuberculosis.
8. Pre-treatment with inhaled glucocorticosteroids for the past 4 weeks.
9. Subjects with concomitant treatment or pre-treatment with systemic or depot glucocortocosteroids within the last 6 months prior to the start of the study.
10. 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.
11. Use of prohibited therapies including long-acting inhaled or oral beta2-agonists, cromones, anticholinergic agents, methylxanthines, leukotriene antagonists, methotrexate, gold salts.
12. Neurological or psychiatric disease or therapy with anti-depressives or neuroleptics.
13. Malignant disease within the last 5 years.
14. Current smokers or smoking history > 10 pack-years (a pack-year is 20 cigarettes per day for one year).
15. Non-co-operative patients not able to understand the instructions for use of the devices or the electronic diaries.
16. Drug or alcohol abuse which would interfere with the subjects´proper completion of the protocol assignment.
17. Participation in another clinical study during or less than 2 months prior to this one.

Administrative reasons:

18. Lack of ability or willingness to give informed consent.
19. 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
Secondary Objective: To show superiority of FP 45 micrograms BID delivered through the Novolizer(R) compared to placebo. To compare safety and tolerability of FP 100 micrograms BID delivered through the Diskus(R) to that 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);Main Objective: To show therapeutic equivalence of fluticasone propionate (FP) 100 micrograms BID delivered through the Diskus(R) and 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 mild to moderate persistent asthma.