Chest
Clinical InvestigationsAsthmaLack of Long-term Adverse Adrenal Effects From Inhaled Triamcinolone: Lung Health Study II
Section snippets
Materials and Methods
In LHS II, 1,116 participants at 10 clinical centers in North America were recruited. Individuals participating (n = 1,018) and screened (n = 98) in the first LHS10 and who were smoking or had recently quit (less than 2 years) comprised the study group. Other inclusion criteria included age between 40 years and 69 years and the presence of obstruction as defined by an FEV1/FVC ratio < 0.70 and an FEV1 between 30% and 90% of predicted. Candidates were excluded if they had used an inhaled or oral
Results
Two hundred twenty-one participants entered the ancillary study of adrenal function, with 106 assigned to the active drug, and 115 assigned to placebo. Both treatment groups were similar with regard to age, gender, race, and baseline pulmonary function. Of the enrolled participants who had baseline measurements of adrenal function prior to initiation of treatment with ICS, 89% underwent repeat testing at year 1 and 85% at year 3 (Table 1). Baseline characteristics of both the enrolled
Discussion
Systemic side effects have been variably reported from the use of inhaled corticosteroids in asthma and COPD. Differences in doses employed, potency, and effectiveness of respiratory delivery between the various formulations of inhaled corticosteroids and in duration of use have contributed to this variability in reported systemic toxicity. LHS II provided an opportunity to study the systemic effects of a moderate dose of inhaled triamcinolone in patients with COPD in whom adherence to a
Appendix
The principal investigators and senior staff of the clinical and coordinating centers, the National Heart, Lung, and Blood Institute, and members of the Safety and Data Monitoring Board are as follows: Case Western Reserve University, Cleveland, OH (M.D. Altose, MD, Principal Investigator; S. Redline, MD, Co-Principal Investigator; C.D. Deitz, PhD; K.J. Quinlan); Henry Ford Hospital, Detroit, MI (M.S. Eichenhorn, MD, Principal Investigator; W.A. Conway, Jr., MD, Co-Principal Investigator; R.L.
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Cited by (21)
Safety of inhaled corticosteroids in COPD
2010, Archivos de BronconeumologiaLong-term trials assessing pharmacological treatments in COPD: Lessons and limitations
2010, Revue des Maladies RespiratoiresThe Association of Inhaled Corticosteroid Use with Serum Glucose Concentration in a Large Cohort
2009, American Journal of MedicineASTHMA AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE
2008, Pharmacology and Therapeutics: Principles to PracticeDrugs acting on the respiratory tract
2005, Side Effects of Drugs AnnualSkin manifestations of inhaled corticosteroids in COPD patients: Results from Lung Health Study II
2004, ChestCitation Excerpt :No differences in the proportion of noncompliant participants reporting slow healing were noted between treatment groups in either age category. In an ancillary study19 to LHS II involving a subset of 221 participants in 5 of the 10 centers, the HPA axis was evaluated at baseline, year 1, and year 3. The development of significantly impaired adrenal function was rare (1.8%),19 and no consistent or meaningful differences were noted between the presence or absence of bruising vs change in basal or stimulated morning serum cortisol level, irrespective of whether analyses were performed in all participants or were restricted to only the good compliers.
Supported under a cooperative agreement with the National Institutes of Health (NHLBI-5U01-HL50267-05). Triamcinolone and placebo, as well as support for the ancillary safety studies on bone density and adrenal function, were provided by Rhône-Poulenc Rorer (now Aventis).
Dr. Wise consulted for Aventis regarding new drug development in September and October of 2000 and received $2,000 compensation.
Dr. Scanlon is currently providing research support for institutional review board-approved protocols (some investigator initiated, some company initiated) from various companies, including Aventis.
Dr. Bailey is participating in an Aventis drug study in progress, a phase III double-blind, parallel-group, multicenter, placebo-controlled study to determine the effectiveness of ciclesonide to reduce oral corticosteroid use in patients with severe persistent asthma.
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A complete list of LHS participants is given in the Appendix