Request for Information (RFI): Ideas for Clinical Trials to be Conducted by the NHLBI Asthma Network (AsthmaNet)

Notice Number: NOT-HL-11-125

Key Dates
Release Date: October 12, 2010
Response Date: October 22, 2010

Issued by
National Heart, Lung, and Blood Institute (


This Notice is a Request for Information (RFI) for clinical trial ideas to be considered by the NHLBI Asthma Network (AsthmaNet).  The RFI solicits opinions from the scientific, medical, and patient communities with an interest in asthma to help shape the research agenda for the AsthmaNet’s study of clinical management approaches in children and adults who have asthma. 


In September, 2009, the NHLBI awarded grants to nine academic centers, each with a principal investigator in pediatric asthma and a principal investigator in adult asthma, and one data coordinating center to develop and conduct multiple clinical trials to address the most important asthma management questions and new treatment approaches in pediatric and adult populations.  Over an anticipated project period of 7 years, 6-8 clinical management trials will be conducted to help identify optimal therapies for a variety of asthma phenotypes, genotypes and racial and ethnic backgrounds.  The knowledge gained will advance clinical practice and inform future updates to the National Asthma Education and Prevention Program’s clinical practice guidelines. Some mechanistic studies linked to the clinical management trials will be conducted, and a limited number of proof of concept studies will be conducted to advance the development of novel therapies. The merger of pediatric and adult asthma expertise into one AsthmaNet will enhance scientific exchange and stimulate research that addresses questions on the similarities, differences, and relationships between childhood and adult asthma.   

Information Requested

The NHLBI invites the scientific community, health professionals, patient advocates, and the general public to provide suggestions on the following questions. Please note: it may be helpful to review all questions first, before preparing responses; respondents may choose to answer as many questions as they choose.  

  1. What are the most important clinical management trial(s) that should be conducted by AsthmaNet?  For each trial listed, please indicate the primary research question to be addressed, the primary outcome of interest, and the targeted study population.
  2. What are the most persistent challenges in keeping a patient’s asthma well controlled?
  3. What are the most important gaps in the NAEPP Expert Panel Report-3: Clinical Practice Guidelines for the Diagnosis and Treatment of Asthma?
  4. What proof-of-concept studies would you recommend AsthmaNet perform?
  5.  Should AsthmaNet undertake intervention trials that address barriers to clinicians or patients implementing or adhering to NAEPP clinical practice guidelines’ recommendations?  If so, what are the most important trials to perform?


To respond by October 22, 2010, please complete and submit the form on line at:

This RFI is for information and planning purposes only and should not be construed as a solicitation, an obligation, or endorsement on the part of NHLBI.  The NHLBI does not intend to award a grant or contract to pay for the preparation of any information submitted or for the NHLBI’s use of such information.  Acknowledgement of receipt of responses may not be made, nor will respondents be notified of the NHLBI evaluation of the information received.  No basis for claims against the NHLBI shall arise as a result of a response to this request for information or the NHLBI’s use of such information as either part of our evaluation process or in developing specifications for any subsequent announcement.  While responses will be held confidential unless permission for sharing information with potential clinical trial collaborators is granted by the respondent, the NHLBI cannot guarantee the confidentiality of the information provided.  Any proprietary information should be so marked.


Questions about this request for information may be directed to:

Virginia Taggart, M.P.H.
Program Director
Division of Lung Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Bethesda, MD 20892-7952
Phone: 301-435-0202

Robert Smith, Ph.D.
Program Director
Division of Lung Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Bethesda, MD 20892-7952
Phone: 301-435-0202

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