Tag: Randomized

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Onset of Bronchodilation with Fluticasone/Formoterol Combination Versus Fluticasone/Salmeterol in an Open-Label, Randomized Study.

Onset of Bronchodilation with Fluticasone/Formoterol Combination Versus Fluticasone/Salmeterol in an Open-Label, Randomized Study.

Adv Ther. 2012 Oct 17;

Authors: Aalbers R, Brusselle G, McIver T, Grothe B, Bodzenta-Lukaszyk A

Abstract
INTRODUCTION: The inhaled corticosteroid, fluticasone propionate (fluticasone), and the long-acting beta(2)-agonist, formoterol fumarate (formoterol), have been combined in a single aerosol inhaler (fluticasone/formoterol). In a randomized, open-label study, fluticasone/formoterol showed similar efficacy to fluticasone/salmeterol after 12 weeks of treatment. This post-hoc analysis compared the onset of bronchodilation with the two treatments. METHODS: Adults with mild-to-moderate-severe persistent asthma were randomized to fluticasone/formoterol (100/10 or 250/10 ?g twice daily [b.i.d.]) or fluticasone/salmeterol (100/50 or 250/50 ?g b.i.d.) for 12 weeks. The onset of bronchodilation (the first post-dose time point at which the forced expiratory volume in 1 second [FEV(1)] was ?12% greater than the pre-dose value), responder rates (the proportion of patients achieving bronchodilation), and changes in FEV(1) were assessed at days 0 (baseline) and 84. RESULTS: Fluticasone/formoterol (n = 101) provided more rapid onset of bronchodilation than fluticasone/salmeterol (n = 101) over the first 120 min post-dose on days 0 (hazard ratio [HR] = 1.47 [95% CI 1.05-2.05]) and 84 (HR = 1.77 [95% CI 1.14-2.73]). The odds of a patient achieving bronchodilation within 5 min of dosing were almost four-times higher with fluticasone/formoterol than with fluticasone/salmeterol on day 0 (odds ratio [OR] = 3.97 [95% CI 1.96-8.03]) and almost 10-times higher on day 84 (OR = 9.58 [95% CI 2.14-42.90]); the odds of achieving bronchodilation within 120 min post-dose were approximately twofold higher with fluticasone/formoterol on both days. The overall percentage increase in least-squares (LS) mean FEV1 during the 120-min post-dose period was significantly greater with fluticasone/formoterol than fluticasone/salmeterol on days 0 (LS mean treatment difference: 4.70% [95% CI 1.57-7.83]; P = 0.003) and 84 (2.79% [95% CI 0.65-4.93]; P = 0.011). CONCLUSION: These analyses showed that fluticasone/formoterol provided a faster onset of bronchodilation than fluticasone/salmeterol, which was maintained over 12 weeks of treatment. This benefit may facilitate treatment adherence among patients with asthma.

PMID: 23081745 [PubMed – as supplied by publisher]

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Asthma Study for African American Women Announced

Call for Participation

Clinicaltrials.gov, a service of the U.S. National Institute of Health is announcing a study protocol for Women of Color and Asthma Control: A randomized controlled trial of an asthma-management intervention for African American women

Among adults in the United States, asthma prevalence is disproportionately high among African American women; this group also experiences the highest levels of asthma-linked mortality and asthma-related health care utilization. Factors linked to biological sex (e.g ., hormonal fluctuations), gender roles (e.g ., exposure to certain triggers) and race (e.g ., inadequate access to care) all contribute to the excess asthma burden in this group, and also shape the context within which African American women manage their condition.

No prior interventions for improving asthma self-management have specifically targeted this vulnerable group of asthma patients. The current study aims to evaluate the efficacy of a culturally- and gender-relevant asthma-management intervention among African American women.

Methods: A randomized controlled trial will be used to compare a five-session asthma-management intervention with usual care.

This intervention is delivered over the telephone by a trained health educator. Intervention content is informed by the principles of self-regulation for disease management, and all program activities and materials are designed to be responsive to the specific needs of African American women.

We will recruit 420 female participants who self-identify as African American, and who have seen a clinician for persistent asthma in the last year. Half of these will receive the intervention.

The primary outcomes, upon which the target sample size is based, are number of asthma-related emergency department visits and overnight hospitalizations in the last 12 months. We will also assess the effect of the intervention on asthma symptoms and asthma-related quality of life.

Data will be collected via telephone survey and medical record review at baseline, and 12 and 24 months from baseline. DiscussionWe seek to decrease asthma-related health care utilization and improve asthma-related quality of life in African American women with asthma, by offering them a culturally- and gender-relevant program to enhance asthma management. The results of this study will provide important information about the feasibility and value of this program in helping to address persistent racial and gender disparities in asthma outcomes.Trial Registration For additional information visit: Clinicaltrials.gov NCT01117805

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Helium-oxygen therapy for infants with bronchiolitis: a randomized controlled trial.

Helium-oxygen therapy for infants with bronchiolitis: a randomized controlled trial.

Arch Pediatr Adolesc Med. 2011 Dec;165(12):1115-22

Authors: Kim IK, Phrampus E, Sikes K, Pendleton J, Saville A, Corcoran T, Gracely E, Venkataraman S

Abstract
OBJECTIVE: To compare nebulized racemic epinephrine delivered by 70% helium and 30% oxygen or 100% oxygen followed by helium-oxygen inhalation therapy via high-flow nasal cannula (HFNC) vs oxygen inhalation via HFNC in the treatment of bronchiolitis.
DESIGN: Prospective, randomized, controlled, single-blind trial.
SETTING: This study was conducted from October 1, 2004, through May 31, 2008, in the emergency department of an urban, tertiary care children’s hospital. Patients  Infants aged 2 to 12 months with a Modified Wood’s Clinical Asthma Score (M-WCAS) of 3 or higher.
INTERVENTIONS: Patients initially received nebulized albuterol treatment driven by 100% oxygen. Patients were randomized to the helium-oxygen or oxygen group and received nebulized racemic epinephrine via a face mask. After nebulization, humidified helium-oxygen or oxygen was delivered by HFNC. After 60 minutes of inhalation therapy, patients with an M-WCAS of 2 or higher received a second delivery of nebulized racemic epinephrine followed by helium-oxygen or oxygen delivered by HFNC. Main Outcome Measure  Degree of improvement of M-WCAS for 240 minutes or until emergency department discharge.
RESULTS: Of 69 infants enrolled, 34 were randomized to the helium-oxygen group and 35 to the oxygen group. The mean change in M-WCAS from baseline to 240 minutes or emergency department discharge was 1.84 for the helium-oxygen group compared with 0.31 for the oxygen group (P < .001). The mean M-WCAS was significantly improved for the helium-oxygen group compared with the oxygen group at 60 minutes (P = .005), 120 minutes (P < .001), 180 minutes (P < .001), and 240 minutes (P < .001).
CONCLUSION: Nebulized racemic epinephrine delivered by helium-oxygen followed by helium-oxygen inhalation therapy delivered by HFNC was associated with a greater degree of clinical improvement compared with that delivered by oxygen among infants with bronchiolitis. Trial Registration  clinicaltrials.gov Identifier: NCT00116584.

PMID: 22147778 [PubMed – in process]

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Asthma control cost-utility randomized trial evaluation (ACCURATE): the goals … – 7thSpace Interactive (press release)

Asthma control cost-utility randomized trial evaluation (ACCURATE): the goals …
7thSpace Interactive (press release)
Despite the availability of effective therapies, asthma remains a source of significant morbidity and use of health care resources. The central research question of the ACCURATE trial is whether maximal doses of (combination) therapy should be used for …

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