Status:
COMPLETED
Fine Particle pMDI Formoterol/Beclomethasone in Asthmatics With and Without Spacer: Comparative Efficacy Evaluation
Lead Sponsor:
Universidade Federal de Pernambuco
Collaborating Sponsors:
Universidade Federal do vale do São Francisco
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Adequate pharmacological treatment controls symptoms in most asthmatics. Pressurized metered dose inhalers (pMDI)are the most used drug delivery devices. Valved holding chambers of different types and...
Detailed Description
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 hol...
Eligibility Criteria
Inclusion
- Adult, age 18 to 65 years, both sexes;
- Clinical diagnosis of moderate to severe persistent asthma;
- Nonsmoker;
- Agree to participate and sign the Informed Consent;
- ACT Score \<= 19
- FEV1 \<= 80% of predicted;
- History of response to FEV1 greater than 10%;
- Patients who are already using Inhaled steroids at medium to high doses (Beclomethasone, budesonide, fluticasone) with longa-acting beta2 agonists (formoterol or salmeterol)
- Proper use of metered-dose inhaler (after orientation)
Exclusion
- Patient diagnosed with Chronic Obstructive Pulmonary Disease (COPD);
- Current smokers or have stopped for less than 10 years;
- Patients with a history of recent near-fatal asthma (less than 12 months);
- Patients with a history of recent asthma hospitalization (last 6 months);
- Patients with airway infection symptoms for less than 4 weeks;
- Participation in any experimental study up to 1 (one) year from selection visit;
- Hospitalization for any reason up to 8 weeks before selection visit;
- History of liver, cardiac, renal, pulmonary or gastrointestinal diseases, epileptic, psychiatric or hematologic disorders, uncontrolled hypertension, rheumatology/orthopedic disorders that interferes with pMDI use;
- Patients unable to properly use the pMDI during the selection
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01453881
Start Date
April 1 2011
End Date
June 1 2013
Last Update
March 31 2015
Active Locations (1)
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1
Hospital das Clínicas - Universidade Federal de Pernambuco
Recife, Pernambuco, Brazil, 50740-520