Financial disclosure and clinical research: what is important to participants?

Objective: To assess what participants in company-sponsored clinical trials wish to know about financial aspects of the study.

Design, Setting And Participants: Cross-sectional questionnaire administered to 324 participants in six clinical trials conducted at the Royal Melbourne Hospital in 1999-2000 and 2006 for non-acute conditions (asthma, chronic obstructive pulmonary disease, osteoporosis, rheumatoid arthritis, diabetes and influenza vaccine efficacy).

Main Outcome Measures: Participants' desire for information on study funding, investigators' conflicts of interest, and use of accrued funds.

Telephone based asthma management - financial and individual benefits.

Methods: The authors calculated the cost of delivering telephone based asthma management compared to usual care. Self efficacy and quality of life were measured at recruitment, 6 months and 12 months. Participants were invited to comment on their experience of the telephone based intervention.

Formoterol Turbuhaler as reliever medication in patients with acute asthma.

The aim of this study was to compare the efficacy and safety of formoterol versus salbutamol as reliever medication in patients presenting at an emergency dept with acute asthma. A randomised, double-blind, double-dummy, parallel group study was performed in four Australian emergency treatment centres. The study included a total of 78 adult patients (mean baseline forced expiratory volume in one second (FEV1) 1.

Hierarchical analysis of large-scale two-dimensional gel electrophoresis experiments.

Large-scale two-dimensional gel experiments have the potential to identify proteins that play an important role in elucidating cell mechanisms and in various stages of drug discovery. Such experiments, typically including hundreds or even thousands of related gels, are notoriously difficult to perform, and analysis of the gel images has until recently been virtually impossible. In this paper we describe a scalable computational model that permits the organization and analysis of a large gel collection.

Formoterol (Foradil) and medium-high doses of inhaled corticosteroids are more effective than high doses of corticosteroids in moderate-to-severe asthma.

This double-blind, randomised, multi-centre, parallel-group study compared the effect of adding Foradil (formoterol fumarate) to existing medium-high doses of inhaled corticosteroids (ICS) with that of doubling the dose of ICS in patients with sub-optimally controlled asthma. After a run-in period, 203 patients with moderate-to-severe asthma who remained symptomatic despite treatment with 500 microg beclomethasone twice daily, were randomised to receive either 12 microg formoterol twice daily (Foradil Aerolizer), Novartis) in addition to beclomethasone 500 microg twice daily, or beclomethasone 1000 microg twice daily and placebo for 12 weeks. The primary efficacy variable was mean morning pre-medication peak expiratory flow (PEF) during the last seven days of treatment.

Trial of roxithromycin in subjects with asthma and serological evidence of infection with Chlamydia pneumoniae.

An association has been reported between chronic infection with Chlamydia pneumoniae and the severity of asthma, and uncontrolled observations have suggested that treatment with antibiotics active against C. pneumoniae leads to an improvement in asthma control. We studied the effect of roxithromycin in subjects with asthma and immunoglobulin G (IgG) antibodies to C.

Bone mineral density and bone turnover in asthmatics treated with long-term inhaled or oral glucocorticoids.

Inhaled glucocorticoids are pivotal in maintenance therapy of chronic bronchial asthma; however, conflict exists over their effects on bone and mineral metabolism. We measured bone mineral density (BMD), bone turnover markers, and adrenal steroid hormones in 53 patients (34 female, 19 male) with chronic bronchial asthma who had taken either inhaled beclomethasone or budesonide in doses of > or = 1500 microg/day for at least 12 months to determine pathogenetic mechanisms of bone loss. To account for the effect of prior oral glucocorticoid exposure we divided patients into two groups: one with (OG) and the other without (IG) a past history of maintenance (> 1 month) oral glucocorticoid therapy.

Patients prefer sedation for fibreoptic bronchoscopy.

This study was carried out in order to determine if intravenous (i.v.) sedation with diazepam, at the time of procedure, made fibreoptic bronchoscopy more tolerable and if these perceptions persisted on later questioning.

Chlorofluorocarbon-free inhalers: are we ready for the change?

Chlorofluorocarbons (CFCs) damage stratospheric ozone permitting enhanced levels of ultraviolet B radiation to reach the Earth's surface. As a result, production of CFCs is now banned under the Montreal Protocol with the exception of their temporary continued use in pressurized metered dose inhalers used to treat those with airway disorders. Replacement propellants have now been identified and shown to be safe and a major exercise is under way to reformulate the commonly used aerosolized medicines with the new propellants.

The change to non-CFC metered dose inhalers.

The first non-chlorofluorocarbon containing (non-CFC) metered dose inhaler (MDI) (i.e. albuterol, Airomir, 3M) has been approved for marketing in over 35 countries.

Chronic lung diseases and the perception of breathlessness: a clinical perspective.

Breathlessness is an extremely common symptom. Its genesis is incompletely understood but is known to be largely determined by many of the mechanical factors associated with the act of breathing. As with all subjective sensations various other factors including volition, behavioural style and other cortical and subcortical factors play a part in its genesis.

Accuracy of asthma death statistics in Australia.

Asthma mortality statistics issued by the Australian Bureau of Statistics (ABS) were compared with clinical data from a survey of asthma mortality. Deaths in Victoria from May 1986 to April 1987 containing 'asthma' in Parts 1 or 2 of the death certificate (N = 405) were reviewed. For each subject, the cause of death attributed by the Victorian Asthma Mortality Survey was compared with the ABS cause of death, by age and sex of the subject.

Aerosol devices in the treatment of asthma. Technical and clinical factors.

Inhaled medications are capable of producing the best bronchial effect with fewest systemic side effects. Proper inhalation technique is critical if these devices are to be effective. Specific aspects of both the system and the inhaler technique used are critical in achieving optimal performance.

Pediatric asthma deaths in Victoria: the mild are at risk.

Previous reviews of pediatric asthma mortality have mostly been from hospital-based clinic populations and suggest that only those with severe asthma are most at risk. This report summarizes an investigation, by interviewer-administered questionnaire, into the circumstances surrounding the death in all patients aged 20 years or less who died from asthma in the State of Victoria over a 3 year period from May 1, 1986. During this period, 51 deaths due to asthma were reported.

Aerosol delivery in lung disease.

Metered-dose inhalers are the preferred method of aerosol delivery under normal circumstances because of their convenient size, ease of use and better patient compliance. Where poor coordination exists a spacer device, breath-activated inhaler or powder inhalation should be used and if muscular weakness presents a problem a Haleraid should be tried. A clinical air pump with jet nebuliser is appropriate if these methods prove unsatisfactory; where wet aerosol has been shown to result in clearly superior effects; for very small children; and for the "brittle" asthmatic prone to sudden life-threatening attacks, especially patients living in isolated conditions.

Deaths from asthma in Victoria: a 12-month survey.

The circumstances surrounding the death of all patients who died from asthma in the State of Victoria over a 12-month period from May 1, 1986 were investigated. Data were collected using an interviewer-administered questionnaire as soon as practicable after registration of the death. In 168 cases asthma was considered to be the cause of death and adequate data were obtained in 163; 75 of these were male (74 over 60 years of age).

Do patients understand asthma? A community survey of asthma knowledge.

Four hundred and twenty-one subjects who attended metropolitan pharmacies in Melbourne that were selected at random were surveyed about the characteristics of, and their knowledge about, their asthma. An unexpectedly-high morbidity was found among 232 persons with asthma, who were aged between 16 years and 75 years. Forty per cent of subjects had been hospitalized at least once for asthma and 15% of subjects were taking maintenance corticosteroid agents by mouth.

The efficacy of nedocromil sodium (Tilade) in asthma.

Nedocromil sodium is a new antiasthmatic drug with properties similar to sodium cromoglycate. We examined the efficacy of nedocromil sodium compared to placebo in 71 asthmatic patients in a three-centre double-blind parallel group study over 12 weeks. During the study the patients' maintenance inhaled corticosteroids were progressively withdrawn.

Alveolar proteinosis treated with a single bronchial lavage.

An acute febrile illness with respiratory failure and pulmonary infiltrates is a recognized accompaniment of many infective and inflammatory diseases. We report a case of pulmonary alveolar proteinosis, with secondary bacterial infection, that responded to a single pulmonary lavage and the elimination of occupational exposure to dust. In contrast to other interstitial lung diseases, therapy with corticosteroid or antibiotic agents alone was not appropriate.

A 4-week Australian multicentre study of nedocromil sodium in asthmatic patients.

The use of nedocromil sodium 4 mg q.i.d.

The potential bronchodilator action of verapamil.

Although calcium antagonists such as verapamil are used primarily in cardiovascular disease, they appear to relax smooth muscle generally. Therefore, the possibility that verapamil might have bronchodilator properties was explored using the guinea-pig tracheal ring technique. Verapamil was found to produce considerable tracheal smooth muscle relaxation from a threshold concentration of 2 X 10(-7) M and with maximum effect at 10(-3) M.