Specific Studies Performed
Some previous studies undertaken by the MEU/Clinical Trials Unit
since 1994
1. A steroid tapering study involving a leukotriene antagonist.
2. Comparative study of CFC & HFA metered dose beclomethasone
inhalers.
3. Phase II (first dose to patients) pharmacokinetic/pharmacodynamic
study of a potassium channel activator.
4. Phase III comparative/additive study involving a leukotriene
antagonist and an inhaled steroid.
5. Bronchodilator action of a new anticholinergic agent in
COPD patients.
6. Pharmacokinetics and pharmacodynamics of a phosphodiesterase
inhibitior in asthmatic subjects.
7. Bronchodilator response after repeat dosing with a LABA
in 49 asthmatics.
8. Protective effect of a leukotriene antagonist against
exercise induced asthma in adolescents.
9. Phase II (first dose in patients) study assessing the protective
effect of a new beta2 / histamine D2 agonist against histamine induced
bronchial provocation.
10. Efficacy of a leukotriene antagonist in severe asthmatics.
A multi-centre study.
11. AMP bronchial challenge study in mild asthmatics investigating
a new inhaler device for a mast cell stabiliser.
12. A 10 day, 50 patient COPD study assessing a new nebulised bronchodilator
compound.
13. Single centre 50 asthmatic patient study assessing the bronchodilator
action of CFC free salbutamol.
14. Multi-centre study assessing the efficacy of a new phosphodiesterase
inhibitor.
15. Phase II seven way crossover histamine challenge study in 20
subjects with a new chemical entity.
16. Multi-centre 8 week study to assess the protective effect of
a LABA and a leukotriene antagonist against exercise
induced Asthma [Top recruiter in UK]
17. International study involving a PDE IV inhibitor in asthmatic
patients.
18. International study involving a PDE IV inhibitor in COPD.
19. Pharmacokinetics and pharmacodynamics of a potassium channel
activator in asthmatics.
20. Bronchial biopsy/BAL study in mild asthmatic patients following
multiple dosing with a new inhaled compound.
21. Long term safety and efficacy of a new phosphodiesterase
inhibitior.
22. A six month study assessing the efficacy of a new inhaled compound
in cystic fibrosis.
23. Multi-centre efficacy/safety study of a new inhaled compound
in COPD.
24. Dose equivalence of 2 steroid inhaler devices using adenosine
monophosphate challenges.
25. Efficacy of long acting beta-agonist in COPD.
26. Multi-centre study assessing gene linkages in asthmatic families.
27. Twelve month study assessing efficacy of an injectable treatment
in severe asthmatics.
28. Single centre 50 patient study assessing bronchodilator action
of a new inhaled beat agonist device.
29. Pharmacokinetics of an ICS in severe asthma and healthy
volunteer subjects.
30. Single centre, single dose study comparing the bronchodilator
effects of a LABA with an anticholinergic and salbutamol
combination in patients with COPD.
31. Pharmacokinetics of an intravenous anti-IL5 compound
in patients with severe asthma [Top recruiter in UK]
32. Six month comparison of a long acting anticholinergic
and a long acting beta agonist in patients with COPD [Top
recruiter in UK]
33. Assessment of the effect of a leukotriene antagonist
on leukotriene D4 induced bronchoconstriction in asthmatic subjects.
34. Pharmacokinetics of an ICS in healthy volunteers
and subjects with COPD.
35. Bioequivalence study of two inhaled steroids
by methacholine challenge.
36. Single centre study in 50 asthmatic subjects.
37. Efficacy and tolerability of two formulations of beclomethasone.
A 160 patient single centre study.
38. Efficacy, safety and tolerability of an anti IL5 compound.
39. Effect of leukotriene D4 injected into the skin of healthy
volunteers.
40. Single dose leukotriene antagonist study assessing protection
against inhaled leukotriene D4.
41. Bronchodilation and bronchoprotection (against methacholine
challenge) by two formulations of a long acting beta agonist.
Single centre 40 patient study.
42. Allergen challenge methodology study.
43. Protection against allergen challenges by two leukotriene
antagonists.
44. Protection against leukotriene D4 challenges by two leukotriene
antagonists.
45. 300 patient, 6 month single centre study assessing safety of
two formulations of beclomethasone.
46. Variability of oxygen saturation in healthy volunteers.
47. Reproducibility of salbutamol bronchodilation dose response
in healthy volunteers using sGaw.
48. Cumulative dose response pharmacodynamics of a new bronchodilator
in asthmatic subjects.
49. Anti-inflammatory effect of an inhaled steroid using
induced sputum.
50. Anti-inflammatory effect of a leukotriene antagonist
using induced sputum [Top recruiter in UK]
51. Assessment of effect on serum cortisol and pharmacokinetics
of an inhaled steroid in severe asthmatic subjects. A 76
patient single centre study.
52. Bicycle work load test study to assess a LTB4
antagonist in COPD [Top recruiter in UK]
53. Efficacy of inhaled steroid / long acting beta agonist
in a new dry powder device.
54. Comparison of two inhaled combination drugs; 40 asthmatic
patients
55. Comparison of two inhaled combination drugs; 40 asthmatic
patients.
56. Immunotherapy study in seasonal allergic rhinitis
patients.
57. Study assessing cough suppressant properties of an NK3 antagonist
in healthy volunteers.
58. Early phase II study investigating a twice weekly inhaled
compound in asthmatic subjects. [Top recruiter in UK]
59. Long acting beta agonist / inhaled steroid treatment study
60. Studies involving an inhaled PDEIV compound in asthma
61. Five way crossover study assessing a new long acting anticholinergic
in COPD
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