Fine Particle pMDI Formoterol/Beclomethasone in Asthmatics With and Without Spacer: Comparative Efficacy Evaluation

Launched by UNIVERSIDADE FEDERAL DE PERNAMBUCO · Oct 17, 2011

Keywords

ClinConnect Summary

This is a randomized, parallel controlled study with blind outcome evaluation to compare the efficacy of the fine particle combination Beclomethasone/Formoterol administered with or without valved holding chamber (Vortex, Pari Innovative Manufacturers, VA - USA.

Eligible asthma patients will begin a 2-weeks run-in period to optimize their control medication use and to learn the correct relief pMDI use without holding chamber. After the run-in, patients with non-controled asthma symptoms (ACT score 19 or under)in spite the use of medium to high dose inhaled steroids and LABA association and...

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Eligibility criteria

• Inclusion Criteria:
• • 1. Adult, age 18 to 65 years, both sexes;
• • 2. Clinical diagnosis of moderate to severe persistent asthma;
• • 3. Nonsmoker;
• • 4. Agree to participate and sign the Informed Consent;
• • 5. ACT Score \<= 19
• • 6. FEV1 \<= 80% of predicted;
• • 7. History of response to FEV1 greater than 10%;
• • 8. Patients who are already using Inhaled steroids at medium to high doses (Beclomethasone, budesonide, fluticasone) with longa-acting beta2 agonists (formoterol or salmeterol)
• • 9. Proper use of metered-dose inhaler (after orientation)
• Exclusion Criteria:
• • 1. Patient diagnosed with Chronic Obstructive Pulmonary Disease (COPD);
• • 2. Current smokers or have stopped for less than 10 years;
• • 3. Patients with a history of recent near-fatal asthma (less than 12 months);
• • 4. Patients with a history of recent asthma hospitalization (last 6 months);
• • 5. Patients with airway infection symptoms for less than 4 weeks;
• • 6. Participation in any experimental study up to 1 (one) year from selection visit;
• • 7. Hospitalization for any reason up to 8 weeks before selection visit;
• • 8. History of liver, cardiac, renal, pulmonary or gastrointestinal diseases, epileptic, psychiatric or hematologic disorders, uncontrolled hypertension, rheumatology/orthopedic disorders that interferes with pMDI use;
• • 9. Patients unable to properly use the pMDI during the selection