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Journal reading 3

Comparative study of long acting -2 agonist and low dose inhaled corticosteroid combination versus medium dose inhaled corticosteroid in therapy of moderate persistent asthma
Presented by:

dr.Ahmad Aswar Siregar

Supervisor :

dr.Amira P Tarigan Sp.P


chronic inflammatory disorder of the airways in which many cells and cellular elements play a role


airway hyper-responsiveness that leads to recurrent episodes of wheezing, breathlessness, chest tightness, and coughing, particularly at night or in the early morning

airflow obstruction within the lung that is often reversible either spontaneously or with treatment


Included criteria

Diagnosed cases of moderate persistent asthma

Aged over 14 years Visiting out patient Department of Tuberculosis and Respiratory Diseases and Department of Postgraduate Medicine, S.N.Medical College, Agra


Excluded criteria

Smokers either active or passive History of lower respiratory tract infection within one month

history of exposure to occupational sensitizer


Patients with known case of chronic obstructive pulmonary disease

Cardiac illness



Methodology to diagnose moderate persistent asthma

Included- daily symptoms, exacerbation that may affect activity and sleep, nocturnal symptoms more than once a week, FEV1 or PEF 60-80% predicted and FEV1 or PEF variability >30%.



Study Design

Jan 5th 2007 - Des 31st 2007

randomized control trial

Baseline values were recorded about symptoms, FEV1, PEF through spirometry

59 cases
treatment twice daily

salmeterol 25g + fluticasone propionate 125 g formoterol 6 g + budesonide 200 g fluticasone propionate 250 g and budesonide 400 g .

The drugs were administered through metered dose inhaler with spacer. All rescue medications were replaced by inhaled levosalbutamol during exacerbations The patients were followed up weekly for 12 weeks. At the end of 12 weeks, spirometry was performed again on each patient and results were compared with base line values


Out of total 69 cases 59 patients followed the strict protocol. Only the results of 59 cases were analyzed. Statistically significant (p value < 0.01) increase in FEV1 was recorded at the end of 12 weeks in each group compared to baseline values.

No significant difference was found in FEV1 values at 12th week (p value>0.05) among these four treatment groups. No significant difference (p value > 0.05) was found in the number of exacerbations in any of two treatment groups , in 12 week study period.

The results of present study suggest that combination therapy (salmeterol+fluticasone , formoterol+ budesonide) is slightly more efficacious and the control is rapid than medium dose

ICS (fluticasone, budesonide)

in treatment of moderate persistent asthma.

Patients of moderate persistent asthma should be treated by

combination of ICS+LABA
initially and maintenance therapy may be

higher dose of ICS

to avoid worsening of asthma associated with long term use of LABA. Whereas patients on high risk of

developing ICS induced side effects

(old age, immunocompromised state, AIDS etc.) should be treated with

combination therapy of LABA and ICS

Thank You



The present study compared the effects of treatment with a combination of low dose ICS with LABA against medium dose ICS in asthma. The results are based on a small exploratory study and should be considered as hypothesis generating rather than definitive.

Statistically significantly increases in FEV 1 at the end of 12 weeks in each treatment group was recorded compared to baseline values but no significant difference was found in FEV1 values at 12th week among these four groups. There was no significant difference in any of the two treatment groups in number of exacerbations. However, number of exacerbations were less in combination therapy

Apart from this, patients receiving combination therapy respond sooner than ICS alone. Our findings are similar to VanNoord et al,11 who used salmeterol 50mcg and fluticasone propionate 250mcg against 500mcg fluticasone propionate twice daily. They found that increase in FEV1 was higher in combination group than fluticasone alone group at the end of 4 weeks but not after 12 weeks. The salmeterol group also showed lesser the need for rescue medication. Similar findings were also observed by Matz et al12. Kips and Pauwels13 got similar results in budesonide and formoterol combination Vs increased dose of budesonide alone. Condemi et al14 and Pearlman.15 found the combination therapy of fluticasone 88mcg and salmeterol 42 mcg significantly better than fluticasone 220mcg alone in terms of FEV1%, PEFR and use ofrescue medicine. Kelsen al16 observed similar finding with salmeterol 42mcg+ beclomethasone 168 mcg versus beclomethasone 336mcg. The difference observed in various studies may be due to difference in patient selection criteria like -level of asthma (mild persistent /moderate persistent/ severe) and difference in drugs doses and mode of drug delivery.