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Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment Guidance for Industry

Chronic Obstructive

Pulmonary Disease:

Developing Drugs for

Treatment Guidance for Industry

DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only.

Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this draft document, contact Dr. Badrul A. Chowdhury at 301-796-2300.

U.S. Department of Health and Human Services Food and Drug Administration
Center for Drug Evaluation and Research (CDER)

May 2016 Clinical/Medical Revision 1

page1image9584

15046dft.doc 5/6/2016

Chronic Obstructive

Pulmonary Disease:

Developing Drugs for

Treatment Guidance for Industry

Additional copies are available from:

Office of Communications, Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor
Silver Spring, MD 20993-0002
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353; Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

U.S. Department of Health and Human Services Food and Drug Administration
Center for Drug Evaluation and Research (CDER)

May 2016 Clinical/Medical Revision 1

 

I. II. III.

A.

1. 2.

3. 4. 5.

6.

TABLE OF CONTENTS

INTRODUCTION............................................................................................................. 1 BACKGROUND ............................................................................................................... 2 DEVELOPMENT PROGRAM ....................................................................................... 3 Overall Considerations .................................................................................................................. 3

Disease Target and Indication.........................................................................................................3 Types of Drugs for COPD................................................................................................................ 3

  1. Improving airflow obstruction .................................................................................................. 3

  2. Providing symptom relief ......................................................................................................... 3

  3. Modifying or preventing exacerbations .................................................................................... 4

  4. Altering disease progression ..................................................................................................... 4

  5. Modifying lung structure........................................................................................................... 4

Drug Development Population ........................................................................................................ 4 Dose Selection.................................................................................................................................. 4 Efficacy Assessment ......................................................................................................................... 5

  1. Objective physiological assessments ........................................................................................ 5

  2. Patient- or evaluator-reported outcome measures..................................................................... 6

  3. Biomarkers and surrogate endpoints ......................................................................................... 7

Recommended Primary and Secondary Efficacy Endpoints............................................................7

  1. Primary efficacy endpoints ....................................................................................................... 7

  2. Secondary efficacy endpoints ................................................................................................... 9

Study Duration.................................................................................................................................9 Number of Studies .......................................................................................................................... 10 Considerations Regarding Demonstration of Efficacy .................................................................. 10

B.

1. 2. 3. 4.

C.

1.

2.

Specific Efficacy Study Considerations...................................................................................... 11

Study Design .................................................................................................................................. 11 Study Populations .......................................................................................................................... 11 Concomitant Treatments................................................................................................................12 Handling of Tobacco Smoking....................................................................................................... 12 Other Considerations................................................................................................................... 12

Drugs Administered by Inhaled Route...........................................................................................12

Combination Drug Products.......................................................................................................... 13

7.
8.
9.
10. Considerations Regarding Demonstration of Safety ................................................................. 10

REFERENCES............................................................................................................................ 14

APPENDIX A: ST. GEORGE’S RESPIRATORY QUESTIONNAIRE IN CHRONIC OBSTRUCTIVE PULMONARY DISEASE STUDIES.......................................................... 15

APPENDIX B: REFERENCES FOR ST. GEORGE’S RESPIRATORY QUESTIONNAIRE..................................................................................................................... 17

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