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Summary of recommendations for the design of clinical trials and the registration of drugs used in the treatment of asthma

Summary of recommendations for the design of clinical trials and the registration of drugs used in the treatment of asthma
Summary of recommendations for the design of clinical trials and the registration of drugs used in the treatment of asthma
With new drugs being introduced to treat asthma it is timely to review criteria that can be used to assess efficacy in clinical trials. Anti-asthma drugs are classified into symptoms-modifying, symptom preventers and disease modifying agents. Attention is drawn to the types of experimental evidence required in preclinical studies to support further clinical development of a new therapy. Clinical trials demand careful selection of patients to maximise the strength of the efficacy signal according to the type of trial being designed. While provocation tests are useful in suggesting efficacy, negative tests do not necessarily indicate lack of anti-asthma activity. Therapeutic trial designs need to take account of duration of treatment, dose–response relationships and confirmatory trials. Outcome measures include symptoms, lung function, reduction in concomitant medication, exacerbations, quality of life and measures of inflammation. Interpretation of results need to include the clinical relevance of any changes as well as statistical significance. Special consideration needs to be given to the evaluation of drugs for acute severe asthma, asthma in children and older people, co-morbidity such as rhinitis, and inhaler devices. As with all drugs introduced into practice, careful attention needs to be paid to both short- and long-term safety.
asthma, clinical trials, drug registration
479-487
Holgate, S.T.
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Bousquet, J.
fda25127-be6f-45cd-a455-883cc90d8e0e
Chung, K.F.
33a71f0f-1a6b-4f86-b685-886578dfd507
Bisgaard, H.
a25617dd-eacd-4967-9c2b-5519d38d83cb
Pauwels, R.
730fef0f-9f79-4346-b04c-100cfb10bd16
Fabbri, L.
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Rabe, K.
594dde8d-80d3-483d-861f-59506191a5ff
Doherty, M.
3ccd8b47-e119-4f38-b813-08e9036a9ff3
Snell, N.J.C.
7bed5a8b-462f-4863-9002-b53bf88b48e5
Cuss, F.
fe97ada5-bdd9-47a1-9561-5ee7ce621944
D'Amato, M.
cf4f681a-d950-49b1-ae47-56b77f206c8c
Reginster, J.Y.
4083b457-5347-4ece-a53e-af19c8868c42
Group for the Respect of Ethics and Excellence in Science (GREES): Asthma section
Holgate, S.T.
2e7c17a9-6796-436e-8772-1fe6d2ac5edc
Bousquet, J.
fda25127-be6f-45cd-a455-883cc90d8e0e
Chung, K.F.
33a71f0f-1a6b-4f86-b685-886578dfd507
Bisgaard, H.
a25617dd-eacd-4967-9c2b-5519d38d83cb
Pauwels, R.
730fef0f-9f79-4346-b04c-100cfb10bd16
Fabbri, L.
6c223283-0588-4e5e-bc1d-6db5ae1297db
Rabe, K.
594dde8d-80d3-483d-861f-59506191a5ff
Doherty, M.
3ccd8b47-e119-4f38-b813-08e9036a9ff3
Snell, N.J.C.
7bed5a8b-462f-4863-9002-b53bf88b48e5
Cuss, F.
fe97ada5-bdd9-47a1-9561-5ee7ce621944
D'Amato, M.
cf4f681a-d950-49b1-ae47-56b77f206c8c
Reginster, J.Y.
4083b457-5347-4ece-a53e-af19c8868c42

Holgate, S.T., Bousquet, J., Chung, K.F., Bisgaard, H., Pauwels, R., Fabbri, L., Rabe, K., Doherty, M., Snell, N.J.C., Cuss, F., D'Amato, M. and Reginster, J.Y. , Group for the Respect of Ethics and Excellence in Science (GREES): Asthma section (2004) Summary of recommendations for the design of clinical trials and the registration of drugs used in the treatment of asthma. Respiratory Medicine, 98 (6), 479-487. (doi:10.1016/j.rmed.2003.12.005).

Record type: Article

Abstract

With new drugs being introduced to treat asthma it is timely to review criteria that can be used to assess efficacy in clinical trials. Anti-asthma drugs are classified into symptoms-modifying, symptom preventers and disease modifying agents. Attention is drawn to the types of experimental evidence required in preclinical studies to support further clinical development of a new therapy. Clinical trials demand careful selection of patients to maximise the strength of the efficacy signal according to the type of trial being designed. While provocation tests are useful in suggesting efficacy, negative tests do not necessarily indicate lack of anti-asthma activity. Therapeutic trial designs need to take account of duration of treatment, dose–response relationships and confirmatory trials. Outcome measures include symptoms, lung function, reduction in concomitant medication, exacerbations, quality of life and measures of inflammation. Interpretation of results need to include the clinical relevance of any changes as well as statistical significance. Special consideration needs to be given to the evaluation of drugs for acute severe asthma, asthma in children and older people, co-morbidity such as rhinitis, and inhaler devices. As with all drugs introduced into practice, careful attention needs to be paid to both short- and long-term safety.

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Published date: 2004
Keywords: asthma, clinical trials, drug registration

Identifiers

Local EPrints ID: 27127
URI: http://eprints.soton.ac.uk/id/eprint/27127
PURE UUID: 6de41dd7-888a-421e-a40b-2ad0347d22ec

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Date deposited: 26 Apr 2006
Last modified: 15 Mar 2024 07:15

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Contributors

Author: S.T. Holgate
Author: J. Bousquet
Author: K.F. Chung
Author: H. Bisgaard
Author: R. Pauwels
Author: L. Fabbri
Author: K. Rabe
Author: M. Doherty
Author: N.J.C. Snell
Author: F. Cuss
Author: M. D'Amato
Author: J.Y. Reginster
Corporate Author: Group for the Respect of Ethics and Excellence in Science (GREES): Asthma section

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