Fine Particle pMDI Formoterol/Beclomethasone in Asthmatics With and Without Spacer: Comparative Efficacy Evaluation
Information source: Universidade Federal de Pernambuco
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Spacer (Device); Comparator (Device)
Phase: Phase 3
Status: Completed
Sponsored by: Universidade Federal de Pernambuco Official(s) and/or principal investigator(s): Jose A Rizzo, PhD, MD, Principal Investigator, Affiliation: Universidade Federal de Pernambuco
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 sizes have also been developed for use in combination with pMDI. The
therapeutic efficacy of treatment depends on the amount of inhaled particles. The chambers
can optimize lung deposition as it obviates lung-hand coordination and retain larger
particles. The aim of this study is to compare the efficacy of the fine particle
combination pMDI Beclomethasone/Formoterol in asthma control,with or without the aid of a
spacer in patients without adequate asthma control on medium to high-dose inhaled steroids
associated with long acting beta adrenergic drugs. The hypothesis is that there is no
clinical efficacy difference between the two forms of drug administration.
Clinical Details
Official title: Randomized Clinical Trials to Compare Asthma Control Efficacy of the Fine-particle Combination Formoterol/Beclomethasone by pMDI Administered With and Without Spacer.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Change in Asthma Control Test Score
Secondary outcome: Changes in Forced Expiratory Volume in the first second (FEV1)
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 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 able to use correctly the
pMDI will be randomized (block-randomization) to receive the test medication combination to
be used with or without the spacer device (VORTEX). Patients will be evaluated after 30 and
60 days. At days 15 (+,- 2) and 45 (+,- 2) they will have an incentive phone call.
ACT score (translated and validated to portuguese - Brazil), FEV1 (Kit-Micro spirometer,
Cosmed, Italy), pMDI use and clinical evaluation will be obtained at initial visit (visit
0), randomization visit (visit 1)and at 30 and 60 days (visits 2 and 3). Extra-medication
allowed at run-in period will be inhaled beta-2 bronchodilators for relief an at treatment
period inhaled beta-2 agonists for relief and systemic steroids for exacerbations, with
antibiotics as needed.
Endpoint evaluations will be proceeded by a treatment blinded investigator. In order to keep
the concealment, the evaluations will be held in a different room and the patients
instructed not to comment on treatment.
Subjects will be excluded at the treatment period in case of severe asthma exacerbation
(hospital or ICU recovery or systemic steroid used for more than 5 days). They will be
excluded also in case of concomitant ailments at discretion of the attending physician.
These patients will be excluded from the per-protocol evaluation but will be described.
Sample size was calculated taking into account a relevant ACT score difference of 3 points
and a SD of 4. 4 (SCHATZ M et all. Asthma Control Test: reliability, validity, and
responsiveness in patients not previously followed by asthma specialists. J Allergy Clin
Immunol 2006;117: 549-56). In order to be able to detect this difference with α and β errors
of 5% and 20% respectively, the investigators calculated 32 patients per group.
Statistical analysis will be carried according to data distribution by a professional
statistician.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Hospital das Clínicas - Universidade Federal de Pernambuco, Recife, Pernambuco 50740-520, Brazil
Additional Information
Starting date: April 2011
Last updated: March 29, 2015
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