Pertussis (Whooping Cough)

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Definition
Pertussis (Whooping Cough) is an acute disease of the respiratory tract. Found in children younger than 5 years, especially in children age 2-3 years.

Cause
Pertussis is caused by gram-negative Bordetella Pertussis.

Clinical Overview
These symptoms occur 1-2 weeks after contact with the infected person and preceded by an incubation period of 7-14 days. Typically, the disease lasts for 6 weeks or more. That is why the disease is called cough hundred days.
On his way, pertussis includes several stages, namely:

• Kataralis which marked the onset of a mild cough, especially at night, accompanied by mild fever and runny nose. This stage lasts 1-2 weeks. In the catarrhal stage indistinguishable from that caused by a viral respiratory infection
• Second is the spasmodic stage lasts 2-4 weeks. Symptoms, cough more often, people with sweat, and blood vessels in the face of wide-neck. Long coughing attack usually ends with a distinctive high-pitched sound (whooping caugh) and accompanied by vomiting. Subconjunctival frequent bleeding and / or epistaxis. Nails and lips become blue because the blood of patients a lack of oxygen. Beyond the attacks, the patient looked healthy.
• In the next stage, namely convalescence, going for two weeks. Symptoms, cough subsided and the patient gradually began to increase appetite.

Diagnosis

• Increased serum IgA specific Bordatella pertussis
• Detected Bordatella pertussis from nasopharyngeal specimens
• Nasopharyngeal swab culture was found Bordatella pertussis

Management

• Pertussis treatment aimed at infecting with appropriate antibiotics, such as erythromycin 30-50 mg / kg 4 times daily.
• Codeine for cough may be given 0.5 mg / year / time.
• Pertussis can be prevented by immunization of DPT (Diphtheria-Pertussis-Tetanus). This immunization is given three times in a row in infants aged three, four, five months.

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Flu Vaccines Can Reduce Respiratory Problems By Up To Three-Quarters

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Annual flu vaccinations are highly effective at preventing acute respiratory illness and
making sure that existing breathing problems don't get any worse, according to
research published in the April issue of IJCP, the UK-based International Journal of
Clinical Practice.



A study of 87 patients with chronic obstructive pulmonary disease (COPD) - a major
cause of ill health and death - found that having the annual flu vaccine reduced
overall problems by more than two-thirds.



The vaccinations were particularly effective at providing protection for patients with
severe COPD, where the incidence of additional respiratory problems fell by threequarters.
"COPD is a serious lung disease that causes breathing problems and is responsible
for a significant number of outpatient and emergency department visits as well as
inpatient hospital stays" says lead author Dr Balakrishnan Menon from the
Vallabhbhai Patel Chest Institute at the University of Delhi, India.



"It has increased by 40 per cent since 1942 and is now the world's fourth leading
cause of death and twelfth leading cause of disability. The World Health Organization
(WHO) predicts that by 2020 it will become the third leading cause of death and rise
significantly in the disability stakes to fifth place.



"Most of the healthcare costs associated with COPD are due to problems that worsen
the condition and infections caused by the influenza virus are major culprits.
"Despite the WHO's recommendation that all patients with COPD should receive the
annual flu vaccine, the injection is not used as widely as it could be, especially in
developing countries.



"Our research suggests that this could be leading to higher levels of respiratory
problems and that these extra healthcare costs could be avoided by improving the
uptake of this simple preventative measure."



The 87 male patients, who had an average age of just under 65, were monitored for
a year before and after they received the vaccine. All had been diagnosed with
COPD, but none of them had previously received the flu vaccine.



After the patients received the vaccine, the overall incidence of acute respiratory
illness and acute exacerbation of COPD fell by 67 per cent, with 24 patients
experiencing them before they received the vaccinee and eight experiencing them in
the post-vaccination period.



The effectiveness of the vaccine varied, depending on how badly people suffered
from the disease. People with mild or moderate COPD saw a 60 per cent reduction in
overall incidence and people with severe COPD enjoyed a 75 per cent reduction.
Outpatient visits fell by 50 per cent after vaccination and there was also a 70 per cent
reduction in the number of study participants who were hospitalised.
















During the two-year study period patients attended monthly check-ups and received
the same level of medication, healthcare and lifestyle advice. Any respiratory
problems were also carefully monitored.



The researchers were careful to ensure that no other factors clouded the results so
that they could observe the effect of the influenza virus more efficiently. This included
having an all male study group. Fewer women met the study criteria, mainly because
they were less likely to smoke ??????" 83 per cent of the men in this study were current or
former smokers.



"Influenza viruses are a major cause of death and serious illness in elderly people,
particularly if they suffer from COPD" concludes Dr Menon.



"Our study was undertaken in a population where uptake of the vaccine is
traditionally low and it had a marked effect on the men who received it. This could
also explain why our 67 per cent reduction was higher than the 32 to 45 per cent falls
reported by previous studies carried out in populations where the vaccine is more
common.



"We believe that our research underlines the importance of increasing vaccine use
worldwide, especially in patients with COPD and in areas where the flu vaccination
rate is low.



"It is clear that annual flu vaccinations have a major role to play in bringing down the
number of preventable deaths and hospital admissions that occur every year in
patients with chronic lung diseases."



"Comparison of outpatient visits and hospitalisations in patients with chronic obstructive
pulmonary disease, before and after influenza vaccination". Menon et al. IJCP, the
International Journal of Clinical Practice. 62.4, pp 593-598.



IJCP, the International Journal of Clinical Practice was established in 1946 and is edited
by Dr Graham Jackson from Guy's and St Thomas' NHS Foundation Trust, London, UK.
It provides its global audience of clinicians with high-calibre clinical papers, including
original data from clinical investigations, evidence-based analysis and discussions on the
latest clinical topics. The journal is published by Blackwell Publishing Ltd, part of the
international Blackwell Publishing group. blackwellpublishing/ijcp



About Wiley-Blackwell

Wiley-Blackwell was formed in February 2007 as a result of the
acquisition of Blackwell Publishing Ltd. by John Wiley & Sons, Inc., and its merger with
Wiley's Scientific, Technical, and Medical business. Together, the companies have
created a global publishing business with deep strength in every major academic and
professional field. Wiley-Blackwell publishes approximately 1,400 scholarly peerreviewed
journals and an extensive collection of books with global appeal. For more
information on Wiley-Blackwell, please visit blackwellpublishing or
interscience.wiley

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Positive Results Of Clinical Studies For Aclidinium Bromide, A Novel Long-Acting Anticholinergic For The Treatment For COPD

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Laboratorios Almirall, S.A. and Forest Laboratories, Inc. presented
results from four clinical trials assessing the efficacy and
safety of aclidinium bromide, an investigational treatment for chronic
obstructive pulmonary disease (COPD). Data from four preclinical studies
further describing the properties of aclidinium were also presented at the
meeting.


Presentations included data from a 464-patient randomized,
double-blind, four-week, Phase IIb study that evaluated both the efficacy and
tolerability of once-daily aclidinium (25 mcg, 50 mcg, 100 mcg, 200 mcg or
400 mcg) or placebo in patients with moderate to severe COPD. An open-label
tiotropium (18 mcg) arm was included as an active control. The study
demonstrated aclidinium (200 mcg and 400 mcg), administered via a multi-dose
dry powder inhaler, significantly increased trough (24 hour) forced
expiratory volume in one second (FEV1) - an important measure of lung
function - on Day 29 compared with placebo (p







"There are still significant unmet needs in the treatment of
COPD. These efficacy and safety data from the Phase II trials are very
encouraging," said Lawrence S. Olanoff, M.D., Ph.D., President and Chief
Operating Officer of Forest Laboratories. "We look forward to the completion
of ACCLAIM I & II trials and continuing the clinical development of
aclidinium for the treatment of COPD."


Results of pre-clinical animal and in vitro studies announced
at the meeting showed that aclidinium exhibited low potential for
cardiovascular effects and was broken down in the plasma within 1.8 to 38
minutes, across the models studied.(5) In addition, aclidinium had a potent
and long-lasting effect on preventing bronchoconstriction in both the human
bronchi and several animal models assessed. (6),(7)
Abstracts from ATS 2008 will be available upon request.


About Aclidinium Bromide


Aclidinium bromide is a novel inhaled anticholinergic
bronchodilator that is currently in phase III clinical development as a
once-daily maintenance treatment for COPD. Almirall licensed US rights to
aclidinium to Forest Laboratories, whilst keeping rights for the rest of the
world. The companies are jointly involved in the development of the compound.


About COPD


COPD is a preventable and treatable lung disease characterized
by chronic airflow limitation that interferes with normal breathing and is
not fully reversible.(8) Globally, an estimated 80 million people have
moderate to severe COPD. In excess of 3 million people died of the condition
in 2005, accounting for 5% of all deaths worldwide.(9)


About Almirall


Almirall, an international pharmaceutical company based on
innovation and committed to health, headquartered in Barcelona, Spain,
researches, develops, manufactures and commercialises its own R&D and
licensed drugs with the aim of improving people's health and wellbeing.
The therapeutic areas on which Almirall focuses its research
resources are related to the treatment of COPD (Chronic Obstructive Pulmonary
Disease), asthma, psoriasis, rheumatoid arthritis and multiple sclerosis.
Almirall's medicines are currently present in over 70
countries with direct presence in Europe and Latin America.


almirall


About Forest Laboratories


Forest Laboratories is a U.S.-based pharmaceutical company dedicated to
identifying, developing, and delivering products that make a positive
difference in people's lives. Forest Laboratories' growing product line
includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for adults for
the initial and maintenance treatment of major depressive disorder and
generalized anxiety disorder; Namenda(R) (memantine HCl), an
N-methyl-D-aspartate (NMDA)-receptor antagonist indicated for the treatment
of moderate to severe Alzheimer's disease; Campral(R)* (acamprosate calcium),
indicated in combination with psychosocial support for the maintenance of
abstinence from alcohol in patients with alcohol dependence who are abstinent
at treatment initiation; and Bystolic(R) (nebivolol), a beta-adrenergic
receptor blocking agent indicated for the treatment of hypertension. For more
information, visit frx.


* Campral is a registered trademark of Merck Sant?© s.a.s., a subsidiary
of Merck KGaA, Darmstadt, Germany.


Except for the historical information contained herein, this release
contains forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements involve a number
of risks and uncertainties, including the difficulty of predicting FDA
approvals, the acceptance and demand for new pharmaceutical products, the
impact of competitive products and pricing, the timely development and launch
of new products, and the risk factors listed from time to time in Forest
Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and
any subsequent SEC filings.

References


(1) Chanez P, Burge S, Dahl R, et al. Once-daily administration of
aclidinium bromide, a novel, long-acting anticholinergic: a Phase II, dose
finding study. American Thoracic Society, May 2008. Poster.


(2) Lasseter KC, Aubets J, Gil E Garcia. Aclidinium bromide, a novel
long-acting anticholingergic, does not affect QT interval in health subjects.
American Thoracic Society, May 2008. Poster.


(3) Ferrer P, Jansat JM, Gil E Garcia. Pharmokinetics and safety of
aclidinium bromide, a novel long-acting, inhaled anticholinergic, in healthy
subjects. American Thoracic Society, May 2008. Poster.


(4) De Miquel G, Schr?¶dter A, Miletzki B, et al. Low systemic exposure to
aclidinium bromide, a novel long-acting anticholinergic, after multiple
doses. American Thoracic Society, May 2008. Poster.


(5) Gras J, Gavald?  A, Llenas J. The preclinical cardiovascular safety
profile of aclidinium bromide, a novel long-acting anticholinergic drug.
American Thoracic Society, May 2008. Poster.


(6) Miralpeix M, Otal R, Carre?±o C, et al. Aclidinium bromide, a novel
anti-muscarinic, reverses cholinergic-induced bronchoconstriction with a fast
onset of action and a long-lasting effect in guinea pigs. American Thoracic
Society, May 2008. Poster.


(7) Cortijo J, Sarri?? B, Gavald?  A. In vitro characterization of
aclidinium bromide, a novel long-acting anticholinergic: effects on isolated
human bronchi. American Thoracic Society, May 2008. Poster.


(8) Global Initiative for Chronic Obstructive Lung Disease. Global
strategy for diagnosis, management, prevention of COPD
(goldcopd) accessed 3 September 2007.


(9) World Health Organisation (WHO). Chronic obstructive pulmonary
disease (COPD). Factsheet number 315; November 2006.

almirall


View drug information on Campral.

Spiriva(R) Consistently Reduces Exacerbations And Associated Hospitalisations In Patients With COPD - Meta-Analysis Of Clinical Studies Shows

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Patients with chronic obstructive pulmonary disease (COPD) treated with Spiriva(R) (tiotropium) for 6-12 months experienced significantly fewer exacerbations and hospitalisations compared with patients receiving placebo according to an analysis of pooled studies presented today at the International Conference of the American Thoracic Society (ATS).1 Spiriva(R) is the first and only once-daily, inhaled anticholinergic medication for maintenance treatment of COPD.


COPD is a progressive respiratory illness that causes significant deterioration of lung function and chronic breathlessness.2 600 million people worldwide already live with COPD, but its prevalence is predicted to rise to become the world's third leading cause of death by 2020.3,4 COPD exacerbations, or an acute worsening of disease symptoms, may accelerate the progression of COPD.2


"These results underline the benefit of effective treatment for patients who suffer with COPD and exacerbations," said Dr David Halpin, Consultant Physician and Senior Lecturer in Respiratory Medicine at the Royal Devon and Exeter Hospital, UK, and study investigator of the pooled analysis. "Exacerbations of COPD significantly reduce a patient's quality of life, and are a major cause of hospitalisation, disability and death. Preventing and treating exacerbations is a key goal of COPD management."


The post hoc analysis was performed on nine, completed, randomised, placebo-controlled, parallel-group Spiriva(R) studies with a duration of six months to one year.


Exacerbations were uniformly defined across all studies as an increase in, or new onset of at least two of the following: cough, sputum, wheezing, dyspnea, or chest tightness with a duration of three days requiring requiring treatment with antibiotics or systemic steroids, or hospitalisation. 6,171 COPD patients were included in the analysis.


Results showed, compared with placebo1:


-- Spiriva(R) significantly reduced the exposure-adjusted incidence rate of COPD exacerbations by 22.6% (65.8 vs. 85.0 per 100 patient-years; p







The Spiriva(R) clinical trials programme has recruited over 25,000 patients.7 Spiriva(R) has demonstrated significant and sustained bronchodilation (opening of the airways)6,8 and reduction in markers of hyperinflation (air trapping).9,10 Spiriva(R) also demonstrated superior and sustained improvements in lung function (FEV1) over ATROVENT(R) (ipratropium bromide) Inhalation Aerosol, a current first-line therapy for COPD, which were maintained over one year6 and has also demonstrated superior improvement in key lung function parameters over salmeterol.11 In addition, in placebo-controlled studies, patients treated with Spiriva(R) had less activity-induced breathlessness and improved exercise endurance. They required fewer doses of rescue medications, had fewer exacerbations and COPD-related hospitalizations.8 In clinical trials, the most common adverse reaction reported with Spiriva(R) was dry mouth, which was usually mild and often resolved during treatment.6,8


According to treatment guidelines of the Global Initiative for Chronic Obstructive Lung Disease (GOLD), long-acting beta-2-agonists and tiotropium, are a preferred treatment option for COPD maintenance therapy.12


About Boehringer Ingelheim


The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 143 affiliates in 47 countries and almost 37,500 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.


In 2005, Boehringer Ingelheim posted net sales of 9.5 billion euro while spending almost one fifth of net sales in its largest business segment Prescription Medicines on research and development.


* Exposure was defined as the cumulative time patients participated in the study from randomisation until the onset of exacerbation, or until discontinuation of treatment.


References


1 Halpin D, Menjoge S, Dusser D, et al. Pooled analysis of effect of tiotropium on COPD exacerbations and related hospitalisations. Abstract presented at ATS 2006, San Diego, USA. 19-24 May 2006.

2 Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease. Executive Summary. GOLD website (goldcopd). Updated 2005.

3 World Health Organization. World Health Report 2004. Statistical Annex. Annex table 2 and 3: 120-131.

4 Murray CJL, Lopez AD. eds. The Global Burden of Disease: a comprehensive assessment of mortality and disability from diseases, injuries, and risk factors in 1990 and projected to 2020. Cambridge; Harvard University Press; 1996.

5 Casaburi R, Kukafka D, Cooper CB, et al. Improvement in exercise tolerance with the combination of tiotropium and pulmonary rehabilitation in patients with COPD. Chest 2005; 127:809-817.

6 Vincken W, van Noord JA, Greefhorst APM, et al. Improved health outcomes in patients with COPD during 1 year's treatment with tiotopium. Eur Respir J 2002; 19:209-216.

7 Boehringer Ingelheim. Data on file.

8 Casaburi R, Mahler DA, Jones PW, et al. A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease. Eur Respir J. 2002;1:217-224.

9 Celli B, ZuWallack R, Wang S, et al. Improvement in resting inspiratory capacity and hyperinflation with tiotropium in COPD patients with increased static lung volumes. Chest 2003; 124:1743-1748.

10 O`Donnell DE, Fluge T, Gerken F, et al. Effects of tiotropium on lung hyperinflation, dyspnoea and exercise tolerance in COPD. Eur Respir J. 2004 23(6):832-48

11 Brusasco V, Hodder R, Miravitlles M, et al. Health outcomes following treatment for six months with once daily tiotropium compared with twice daily salmeterol in patients with COPD. Thorax 2003;58:399-404.

12 Pocket Guide to COPD diagnosis, management, and prevention - A guide for healthcare professionals. Global Initiative for Chronic Obstructive Lung Disease. Available at: goldcopd


boehringer-ingelheim

New Study Demonstrates Rapid Speed Of Onset With Budesonide/formoterol In COPD

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New data from a study investigating the
onset of action with respect to airway dilatation in budesonide/formoterol
(Symbicort(R)), salmeterol/fluticasone (SeretideT), salbutamol and placebo
were announced today at the European Respiratory Society 2006 Annual
Congress (ERS)1. The data show that budesonide/formoterol has an onset of
action that is similar to that of salbutamol and faster than that of
salmeterol/fluticasone in patients with COPD.


"Speed of onset is as important in COPD as it is in asthma, especially in
the morning when patients often require a rapid onset of bronchodilatory
effect. Rapid symptom relief from a maintenance treatment will most likely
also provide improved compliance. Therefore the data presented today is very
interesting and adds to our understanding of the role of
budesonide/formoterol in treatment of COPD," said Professor Martyn R.
Partridge, Faculty of Medicine, Imperial College London.


In the double-blind, double-dummy, placebo-controlled crossover study, 88
patients were randomised to four treatments to receive either single doses
of budesonide/formoterol, salmeterol/fluticasone, salbutamol or placebo in
order to compare the onset of action in patients with COPD. Treatments were
administered via pressurised metered dose inhalers (pMDI)*. The primary
endpoint was an improvement in airway dilatation measured by a change in
FEV1 at 5 minutes after inhalation.


The study showed that budesonide/formoterol improved FEV1 to a greater
extent than placebo and that the onset of effect with budesonide/formoterol
was similar to that seen with reliever therapy salbutamol and faster than
salmeterol/fluticasone. Maximal effect on Inspiratory Capacity, regarded as
predictor of exercise tolerance, was greater with budesonide/formoterol as
compared to salmeterol/fluticasone. Improvement in lung function parameters
for all three active treatments was superior to placebo after 180 minutes,
but the two combination treatments were better than the SABA alone at
maintaining the improvement in FEV1.


"Speed of onset is as important in COPD as it is in asthma, especially in
the morning when patients often require a rapid onset of bronchodilatory
effect. The findings from the study confirm that rapid onset of action can
also be exerted by maintenance therapies in COPD," concluded Martyn R.
Partridge.


* Budesonide/formoterol is licensed for use in COPD patients with an
FEV1

COPD Pathophysiology

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Most cases of chronic obstructive pulmonary disease caused by long term smoking. Inhaling lung irritants like pollen, air pollution, dust, fumes and other chemicals can also Contributing to this disease. Early signs of this disease is a chronic cough and coughing up mucus secretion. Other associated symptoms may include difficulty breathing, chest tightness or discomfort, wheezing and other respiratory symptoms. A patient with COPD are more prone to constant chest infections than healthy individuals. Thus Spake, COPD is a major cause of medical complications and death in many countries. In medicine, there is no cure for COPD. To put in simple words, damage to the airways can not be reversed again. But there are some treatment options that can help manage symptoms of shortness of breath. The most effective approach to treatment of COPD is to quit smoking, one can opt for nicotine replacement therapy to cope with nicotine withdrawal symptoms. Likewise, avoid exposure to chemicals and lung irritation as far as possible. Other treatment options for COPD include oxygen therapy (if necessary) and drugs such as corticosteroids and antibiotics (for a chest infection)Pathophysiology of lung diseases are very complex and not fully understood. A resistance to air flow can be caused by many factors such as mucociliary disorders, inflammatory response and structural changes. In summary, blockage or narrowing of the airway can be caused by loss of elasticity of the airways, damage or inflammation of the airway wall, excess mucus secretion in the airways and decrease in surface area for gas exchange. According to medical research, a chronic inflammatory response in the airways is a major factor for the development of COPD. This suggests that the inflammatory response due to COPD and asthma are different from them.

Moderate COPD Prognosis

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Respiratory disease has grown in recent years and there is more risk of other health complications associated with the disease to grow, if not treated in time. Prognosis moderate COPD is one of the conditions that can be described as a worsening of respiratory disease conditions. And to know better first of all we will get a glimpse of COPD. Chronic obstructive pulmonary disease can be described as a combination of several respiratory diseases such as bronchitis, asthma and emphysema.It could also be called as part of this disease. The lungs may fall and the surrounding tissue is also damaged by the disease. This inhibits the flow of air in the lungs, making breathing problems. Once the condition worse and cause serious risks, it is called a COPD exacerbation.According to the Global Initiative for Obstructive Lung Disease, which is abbreviated as 'GOLD', COPD exacerbation is defined as, "an event in the natural course of disease, characterized by fundamental changes in patient's dyspnea cough, and sputum, which is beyond ordinary day-to-day variations. is acute in onset and may require changes in the treatment of patients suffering from COPD.Prognosis moderate COPD is a term used to describe both chronic bronchitis or emphysema, or in some cases both. In some cases, also known as Chronic Obstructive Airways Disease (Coad). In this condition, there are inhibiting the flow of air into the lungs due to narrowing of the airways.Smoking is the main cause of this condition. As I've mentioned before, there are four stages of Chronic Obstructive Pulmonary Disease. Phase I is the stage of mild COPD, phase II is moderate stage III and stage IV is severe severe cases of COPD. Although the final stage is referred to as the final stage, does not change means that patients only have a few more days on earth. Rather late stage means that the symptoms of COPD COPD worse at this stage is often severe.