A single dose, randomized, double blind, double dummy, placebo controlled, three-period crossover clinical study, comparing the onset of relief from methacholine induced bronchoconstriction with fixed combination beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg/actuation pMDI with HFA-134a propellant (Foster®) versus standard salbutamol pMDI 100 µg/actuation (Ventolin® 100 µg) therapy in asthmatic patients - MART1
- Conditions
- AsthmaMedDRA version: 9.1Level: LLTClassification code 10003553Term: Asthma
- Registration Number
- EUCTR2008-000905-12-GB
- Lead Sponsor
- CHIESI FARMACEUTICI S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 54
1. Subject’s written informed consent.
2. Outpatients of both sexes aged = 18 years.
3. Diagnosis of asthma for a minimum of 6 months prior to Visit 1.
The evidence of asthma must be confirmed through 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 or through a positive response to methacholine challenge test (PC20 < 8 mg/mL or PD20 < 1 mg). In
case this is not achieved, a positive historically documented FEV1 reversibility or response to methacholine challenge test within the previous 6 months is acceptable for the diagnosis of asthma. The investigator, according to his/her clinical judgment, will decide about performing the reversibility test or the methacholine challenge test.
4. Baseline FEV1 > 70% of the predicted normal value and at least 1.5 L, after appropriate washout from bronchodilators.
5. Patients on previous treatment with low-medium doses of ICS (200 - 1000 µg BDP CFC daily or equivalent) or ICS + LABA fixed or free combinations (daily dose of budesonide 200 - 800 µg/fluticasone 100 - 500 µg or equivalent ICS doses plus
formoterol 12 - 24 µg of salmeterol 50 - 100 µg) at a stable dose for at least 2 months prior to inclusion. The fixed combination therapies must be switched to the free components ICS alone at the same dose + LABA alone at the same dose in order to stop LABA only 48 hours before each clinic visit.
6. A cooperative attitude and ability to be trained about the proper use of a pMDI.
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
1. Patients with other lung diseases such as (but not limited to) COPD (Chronic Obstructive Pulmonary Disease), cystic fibrosis, interstitial lung diseases or any other clinically or functionally significant lung disorder.
2. Patients who experienced an acute bronchoconstriction induced by methacholine that, according to the investigator’s opinion, could not be easily managed through SABAs.
3. Patients having received an investigational drug within 2 months.
4. Patients having suffered from a heart attack or stroke within the previous 3 months.
5. Patients with a known aortic or cerebral aneurysm.
6. Patients suffering from uncontrolled hypertension (systolic pressure > 200 and/or diastolic pressure > 110 mmHg).
7. Patients who suffer from uncontrolled cardiovascular, respiratory, haematological, immunologic, renal, neurologic, hepatic, endocrinal or other diseases, as well as any condition that might, in the judgement of the investigator, represent for the patients an undue risk or that could compromise the results or the interpretation of the study.
8. 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.
9. 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 V1.
10. 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).
11. Use of systemic steroids within 6 weeks prior to Visit 1.
12. Intolerance/hypersensitivity or contra-indication to treatment with ß2-agonists and/or inhaled steroids.
13. Any change in dose, schedule, formulation or product of previous ICS or fixed/free combination ICS + LABA in the 2 months prior to screening visit.
14. Moderate/severe exacerbation and/or intake of oral corticosteroids during the run-in period.
15. Patients treated with slow-release corticosteroids in the 3 months prior to screening visit.
16. Patients being treated with anti-IgE antibodies.
17. Latest moderate/severe asthma exacerbation within 6 weeks.
18. Inability to comply with study procedures or with study treatment intake.
19. Significant response to the diluents, (i.e., > 15% fall in FEV1 from the patient’s FEV1 at baseline, prior to commencing the methacholine challenge test).
20. Upper or lower respiratory tract infection within the previous 6 weeks.
21. History of near fatal asthma.
22. Any acute or clinical condition that put the patient at risk or may alter the interpretation of the test.
23. Pregnant or lactating women. Females of childbearing potential without an efficient contraception. Pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum human chronic gonadotrophin laboratory test (> 5 mIU/mL). Women of child-bearing potential are defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL or are using one or more of the
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the onset of relief from methacholine-induced bronchospasm with a single dose of Foster® 100/6 versus standard salbutamol pMDI 100 µg/dose therapy, in terms of pulmonary function [time to recovery in FEV1 (return to 85% of baseline)] in asthmatic patients on low-medium doses of ICS (Inhaled corticosteroid).;Secondary Objective: To evaluate the effect of the treatments on additional lung function parameters and clinical outcome measures of Foster® 100/6.;Primary end point(s): Time to recovery in FEV1 (return to 85% of the baseline).
- Secondary Outcome Measures
Name Time Method