Methods for identifying a patient as a candidate for treatment with a long acting beta agonist and for predicting a patient's response to long acting beta 2 agonist therapy by analysing polymorphisms

An agonist, candidate technology, applied in receptors/cell surface antigens/cell surface determinants, biochemical devices and methods, specific peptides, etc., which can solve problems such as adverse side effects

Inactive Publication Date: 2007-10-17
ASTRAZENECA AB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, long-term use of any drug may have different effects on different individuals
Especially long-term use may lead to tolerance and adverse side effects such as headaches, tremors and palpitations

Method used

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  • Methods for identifying a patient as a candidate for treatment with a long acting beta agonist and for predicting a patient's response to long acting beta 2 agonist therapy by analysing polymorphisms
  • Methods for identifying a patient as a candidate for treatment with a long acting beta agonist and for predicting a patient's response to long acting beta 2 agonist therapy by analysing polymorphisms
  • Methods for identifying a patient as a candidate for treatment with a long acting beta agonist and for predicting a patient's response to long acting beta 2 agonist therapy by analysing polymorphisms

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0184] Samples for genotyping were taken from four Viozan TM2450 patients were enrolled in phase III clinical trials SC-397-5097, SC-397-5098, SC-397-5099 and SC-397-5163. The patient population included male and female patients, aged 40 to 80 years, with stable COPD, symptoms for ≥2 years, and a history of smoking for at least 15 pack years. The study included those exhibiting pre- and post-bronchidilation FEV1 / FVC (forced vital capacity) less than 65% (of predicted normal), and 20-70% of predicted normal. Patients with FEV1. More details on patient populations and study design are described in Laursen et al. Respiratory Medicine (2003), Vol 97, Suppl A, S23-S33. Participation in the genetics substudy is voluntary. Patients gave independent written informed consent for genetic analysis. Patients agree to provide DNA for use in research on Viozan TM Reaction. Viozan TM It is a dual agonist, targeting the β2-adrenoceptor and dopamine D2 receptor genes, and was developed ...

Embodiment 2

[0197] Example 2 - Haplotype - Lung Function Analysis

[0198] Pre-dose and post-dose FEV1 (forced expiratory volume in 1 second), the volume of air exhaled in the first second during the FVC maneuver (manoeuvre) (in liters indicated), for all patients their measurements were obtained at each study visit, as described in the clinical study protocol. Spirometry was performed at each center using standard techniques. Details on the spirometer used and calibration records were provided by each centre. After a 15-minute rest period, slow vital capacity (SVC; slow vital capacity), forced vital capacity (FVC) and FEV1 were determined for at least three separate manipulations (manoeuvre). Record the maximum value for each parameter.

[0199] In a subgroup of patients (all of whom showed ≥5% FEV1 reversibility in response to the inhaled SABA salbutamol (salbutamol) 400 μg), serial FEV1 measurements (at 5, 15, 30, 45, At 60, 90, and 120 minutes, and hourly thereafter until 8 hours ...

Embodiment 3-

[0205] Example 3 - Haplotype-Symptom Score Association

[0206] Changes in COPD symptoms were assessed using the BCSS (Breathness, Cough, and Phlegm Score), also known as the TSS (Total Symptom Score). Each symptom, shortness of breath, cough, and phlegm, was assessed daily by the patient and recorded in a diary using a 5-point Likert scale (ranging from 0 to 4, with higher scores indicating more severe symptoms). The three item scores are combined to calculate the BCSS total score, resulting in a value between 0 and 12. The reliability and validity of the BCSS for assessing symptoms in COPD is discussed in Leidy et al., 2003, Respiratory Medicine, Vol 97, SupplA, S59-S70. A mean change of ±1 point in the BCSS total score represents a substantial improvement in symptom severity in patients with moderate to severe COPD (Celli et al. Respiratory Medicine, (2003) Vol 97, SupplA, S35-43).

[0207] Figure 5 shows the change from baseline BCSS for patient subgroups stratified by A...

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Abstract

The invention relates to a method for identifying a patient as a candidate for treatment with a long acting beta agonis comprises isolating a biological sample from a patient an identifying the presence or absence of at least one haplotyp C in the beta2 -adrenergic receptor gene. The presence of a least one haplotype C in a patient sample indicates tha patient is a good candidate for treatment. For example, th patient may have a respiratory disease, preferably a obstructive airway disease, and most preferably, COPD o asthma. The invention also related to a method for predictin an asthma patient's response to long acting beta2 agonis therapy comprising detecting polymorphisms in the beta2 adrenergic receptor gene.

Description

technical field [0001] The present invention relates to the identification of the relationship between haplotypes comprising some single nucleotide polymorphisms in the beta2-adrenergic receptor gene, and to the identification of Responses to long-acting beta agonists that allow identification of suitable candidates for drug therapy. Background technique [0002] The β2-adrenergic receptor (ADRB2 or B2AR) is a G protein-coupled receptor that mediates the effects of catecholamines in many tissues. ADRB2 activity plays an important role in regulating cardiac, vascular, pulmonary and metabolic functions. Alterations in ADRB2 receptor activity or expression are believed to increase the risk or severity of a number of diseases and conditions, including congestive heart failure, arrhythmia, ischemic heart disease , hypertension, migraine, asthma, chronic obstructive pulmonary disease (COPD), anaphylaxis, obesity, diabetes, myasthenia gravis ) and premature birth (premature). ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/68C07K14/705C12Q
CPCC12Q2600/172C12Q1/6886C12Q2600/106
Inventor 海伦·J·安布罗斯米切尔·J·戈德曼
Owner ASTRAZENECA AB
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