Criteria for Inclusion
Patients with a history of chronic bronchitis, ie, cough daily and expectoration for at least three consecutive months for the last two years were included in the study. They were recruited among the outpatients of the clinic. They should be cooperative and capable to follow the instructions for the treatment. Smokers and nonsmok- ers were included; exsmokers were included only if they had stopped smoking at least two years prior to the study. Patients with bronchial asthma, heart failure, or lung cancer were not included. Asthma was defined as a 20 percent or higher increase in forced expiratory volume in the first second (FEV,) after inhalation of 1.25 mg of terbutaline through a 750 ml volume cone spacer. Patients who already used a PEP mask, used prophylactic mucolytic drugs, or received more than 10 mg prednisolone (or equivalent doses of corticosteroids) daily could not take part in the study. A total of 44 patients were included in the study in the months of January or February and followed for 12 months, and 10 patients were included in October and followed for 4 to 5 months.
Criteria for Exclusion During the Study
Death, diseases or hospitalization interfering with the treatment, or discontinued treatment during the study lead to exclusion from the data analysis. Data from patients receiving antibiotics for more than two weeks because of diseases other than exacerbations of chronic bronchitis, more than 10 mg prednisolone (or equivalent) daily, or mucolytics daily for more than four consecutive weeks were excluded.
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The patients were included after informed consent and both verbal and written information was given. The study was approved by the Ethics Committee of Aarhus and was in accordance with the Helsinki Declaration II.
The patients were randomly allocated to treatment with self- administered diaphragmatic breathing followed by forced expirations and cough until expectoration succeeded (control group) or PEP treatment where diaphragmatic breathing was performed through a PEP mask followed by forced expirations and cough. The patients were taught a respiratory force to create a pressure of 12 to 20 cm H20, and the expiratory pressure was measured by a manometer. The patients were instructed by a specialized and trained physiotherapist. The actual pressure level was individually determined according to the capability to breathe 10 to 15 times in the mask. The patients were instructed to use either treatment every morning and evening for 10 to 15 breaths repeated until expectoration had stopped. They were allowed use the treatments more often if needed. The patients continued their treatment with beta4-agonist, theophylline, and corticosteroid. Acute exacerbations were treated with antibiotics, mucolytics, and adjustment of bron- chodilators and corticosteroids when needed.
Twice a week, the patients filled in a diary card with questions concerning symptoms. The following was answered by yes or no: Do you feel ill? Is your temperature (rectal) more than 38°C? Are you on sick leave from work? Are you being treated with antibiotics? The following questions were graded from 0-3 according to specified qualities in the grades: severity of cough, severity of dyspnea, amount of secretion, color of secretion, thickness of secretion, and difficulty in expectoration. The patients also wrote the number of treatments used daily. Finally, every month, the patients answered questions graded from 0-2 according to severity (more, equal or less) of dyspnea, cough, and expectoration during the last month compared to these symptoms at the start of the study. The diary was modified from a multicenter study that found it very suitable for assessment of the rate of exacerbation. The diary cards were collected every month. From the diaries, the subjective symptoms, the number of acute exacerbations, the number of sick leaves, and days with antibiotics were evaluated.
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An acute exacerbation was defined as the appearance of mucopurulent or purulent sputum and increasing cough and one or more of the following symptoms: temperature >38°C, general malaise, increased dyspnea, increased mucus production, increased mucus thickness, or increased difficulty in expectoration.