Efficacy and Tolerability of Beclometasone/Formoterol Single Inhaler in Patients With Moderate to… (NCT00476268) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Tolerability of Beclometasone/Formoterol Single Inhaler in Patients With Moderate to Severe Persistent Asthma
824 participantsStarted 2004-02
Plain-language summary
Efficacy and tolerability of the fixed combination beclometasone/formoterol in patients with moderate to severe persistent asthma.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 \> 47…