Asthma
Conditions
Brief summary
Efficacy and tolerability of the fixed combination beclometasone/formoterol in patients with moderate to severe persistent asthma.
Detailed description
The purpose of this study is to evaluate the efficacy and tolerability of beclometasone/formoterol single inhaler in a twice daily regimen in patients with moderate to severe persistent asthma. Patients are randomised to receive either beclometasone/formoterol single inhaler (total daily dose: BDP/FF 400/24 mcg) or beclometasone CFC + formoterol DPI (total daily dose: BDP 1000 mcg + FF 24 mcg) or beclometasone CFC (total daily dose: BDP 1000 mcg) during 24 weeks of treatment.
Interventions
DRUGbeclomethasone/formoterol (100/6µg) pMDI
Two puffs b.i.d
DRUGBeclometasone dipropionate 250 µg/unit dose pMDI
2 inhalations bid
DRUGFormoterol powder 12 µg/unit dose
2 inhalations bid
Sponsors
Chiesi Farmaceutici S.p.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of moderate to severe persistent asthma (according to GINA 2002 guidelines) * FEV1 \> 40% and \< 80% of predicted normal post-bronchodilator (and at least 0.7 L absolute value) * Patients already treated for at least 2 months with an association of inhaled corticosteroids plus LABA at doses of: 750 - 1000 µg beclomethasone dipropionate or equivalent (ICSs) 24 µg formoterol or 100 µg salmeterol (LABAs) * Or patients naïve of LABA already treated for at least 2 months with inhaled corticosteroids (doses as above) associated with a daily use of SABA and/or with clinical symptoms \> 3 times in the week prior to inclusion * A documented positive response to the reversibility test.
Exclusion criteria
* Pregnant or lactating females or women of childbearing potential without any efficient contraception. * Heavy smokers defined as smoking for \> 10 pack years. * Evidence of asthma exacerbation causing an hospitalisation or requiring treatment with oral/parenteral corticosteroids or evidence of symptomatic airways infection in the 4 weeks prior to inclusion (3 months for slow-release corticosteroids). * Seasonal asthma or asthma occurring only during episodic exposure to an allergen or occupational chemical sensitizer. * Clinically significant or unstable concomitant diseases, including clinically significant laboratory abnormalities. * Patients with an abnormal QTc interval value in the ECG test, defined as \> 450 msec in males or \> 470 msec in females. * Evidence of asthma worsening during the week preceding randomisation (e.g. PEF variability \> 30% during 2 consecutive days, SABA use \> 8 puffs/day during 2 consecutive days, nocturnal awakenings due to asthma symptoms during 3 consecutive days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pre-dose morning PEF | End of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Other spirometric parameters | At clinic visits |
| Morning and evening asthma clinical symptom scores | End of treatment |
| Percentage of night and/or days free of clinical symptoms | End of treatment |
| Pre-dose FEV1 | At clinic visits |
| Asthma exacerbations | end of treatment |
| safety and tolerability | end of treatment |
| Use of rescue short-acting b2-agonists | End of treatment |
Outcome results
None listed