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Effect of Treatment With Fluticasone With and Without Salmeterol on Airway Inflammation and Lung Function in Patients With Chronic Obstructive Pulmonary Disease FREE

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The summary below is from the full report titled “Effect of Fluticasone With and Without Salmeterol on Pulmonary Outcomes in Chronic Obstructive Pulmonary Disease. A Randomized Trial.” It is in the 20 October 2009 issue of Annals of Internal Medicine (volume 151, pages 517-527). The authors are T.S. Lapperre, J.B. Snoeck-Stroband, M.M.E. Gosman, D.F. Jansen, A. van Schadewijk, H.A. Thiadens, J.M. Vonk, H.M. Boezen, N.H.T. ten Hacken, J.K. Sont, K.F. Rabe, H.A.M. Kerstjens, P.S. Hiemstra, W. Timens, D.S. Postma, P.J. Sterk, and the GLUCOLD (Groningen Universities Corticosteroids in Obstructive Lung Disease) Study Group.

Ann Intern Med. 2009;151(8):I-21. doi:10.7326/0003-4819-151-8-200910200-00001
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What is the problem and what is known about it so far?

Chronic obstructive pulmonary disease (COPD) is a disease of the lungs that is usually caused by smoking. People with COPD are short of breath. They sometimes have spasms in their bronchial tubes (the lungs' airways), and they cough and wheeze. Symptoms and lung damage slowly get worse over time. Most patients also have bouts when their symptoms worsen.

Doctors use several drugs to treat COPD. Many are given by using inhalers or “puffers.” In an inhaler, the drugs are in solutions in small pressurized cans with pumps. Patients put the pump's mouthpiece in their mouth and push the pump as they start to inhale deeply. They then hold their breath for about 5 to 10 seconds so that their airways absorb the medicine. The standard metered-dose inhaler releases a fixed dose of medicine in aerosol form. Examples of drugs given by inhaler include fluticasone (a steroid drug that decreases inflammation), salmeterol (a drug that expands the breathing tubes, known by the brand name Serevent [manufactured by GlaxoSmithKline]), and a combination of fluticasone and salmeterol (manufactured by GlaxoSmithKline and known by the brand name Advair in the United States and Seretide in Europe). Although these drugs can improve symptoms, their effects on inflammation and lung function over the long term have not been well studied.

Why did the researchers do this particular study?

To examine the long-term effects of fluticasone with and without salmeterol on airway inflammation and lung function in patients with COPD.

Who was studied?

114 current or former smokers with moderate to severe COPD who had never received treatment with steroid drugs.

How was the study done?

The researchers randomly assigned patients to receive treatment with fluticasone twice per day for 6 months or 30 months, fluticasone plus salmeterol for 30 months, or placebo for 30 months. Placebo inhalers looked and worked like the other inhalers but contained no active ingredients. Patients had tests to measure inflammatory cells in the lungs and lung function at the start of the study and again at 6 and 30 months and lung function every 3 months.

What did the researchers find?

Fluticasone decreased inflammation and slowed decreases in lung function, but these improvements stopped when patients stopped receiving fluticasone. Adding salmeterol had no additional effect on inflammation or prevention of decreases in lung function at 6 or 30 months.

What were the limitations of the study?

Almost one quarter of the patients did not have the test to measure inflammation at 30 months.

What are the implications of the study?

Fluticasone decreases inflammation and slows decrease in lung function in patients with moderate to severe COPD. Adding salmeterol did not provide additional benefit in these outcomes.





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