Skip to main content

Short-term safety of somatropin inhalation powder in adults with mild to moderate asthma

Buy Article:

$39.50 plus tax (Refund Policy)

Abstract:

Systemic therapeutic protein delivery through the lungs could potentially replace delivery by injection, but safety needs to be established in patients with known pulmonary disease. This study determined the short-term safety profile of recombinant human growth hormone (rhGH; somatropin) inhalation therapy in clinically stable adult subjects with mild to moderate asthma and methacholine sensitivity. This randomized, placebo-controlled study had two phases: (1) an escalating 3-dose, 4-day/dosage tolerance phase; and (2) a 14-day, crossover design comparability phase. Noninferiority in maintaining forced expiratory volume in 1 second (FEV1) was tested for somatropin inhalation powder (SIP) compared with subcutaneously injected rhGH (Hsc) and inhaled placebo. Lung hyperresponsiveness was assessed by methacholine bronchoprovocative challenge, and adverse events (AEs) were recorded. Eight and 18 subjects enrolled in the first and second phases, respectively. Noninferiority of SIP compared with Hsc and placebo was established for FEV1 after the first and last doses, and noninferiority of SIP compared with Hsc for methacholine challenge was established after the first dose. Pulmonary uptake and systemic distribution of SIP was confirmed by increased serum insulin-like growth factor I levels. Mild, nonprogressive cough and nasal congestion occurred more commonly with SIP. All other treatment-emergent AEs were mild, similar across active treatment groups, and consistent with rhGH treatment. In clinically stable adults with mild to moderate asthma, no significant changes in pulmonary function or worsening of asthma complaints occurred during SIP treatment. Future studies of SIP may enroll subjects with mild to moderate asthma for longer-term evaluation of safety and efficacy.

Keywords: Asthma; FEV1; drug inhalation; growth hormone; lung; pulmonary; rhGH; safety; somatropin; somatropin inhalation powder

Document Type: Research Article

DOI: http://dx.doi.org/10.2500/aap.2009.30.3236

Affiliations: Department of Medicine, National Jewish Health, Denver, Colorado, USA. nelsonh@njhealth.org

Publication date: May 1, 2009

More about this publication?
  • Allergy and Asthma Proceedings is a peer reviewed publication dedicated to distributing timely scientific research regarding advancements in the knowledge and practice of allergy, asthma and immunology. Its primary readership consists of allergists and pulmonologists.

    The goal of the Proceedings is to publish articles with a predominantly clinical focus which directly impact quality of care for patients with allergic disease and asthma.

    Featured topics include asthma, rhinitis, sinusitis, food allergies, allergic skin diseases, diagnostic techniques, allergens, and treatment modalities. Published material includes peer-reviewed original research, clinical trials and review articles.

    Articles marked "F" offer free full text for personal noncommercial use only.

    The journal is indexed in Thomson Reuters Web of Science and Science Citation Index Expanded, plus the National Library of Medicine's PubMed service.
  • Editorial Board
  • Information for Authors
  • Submit a Paper
  • Information for Advertisers
  • Reprint Requests
  • ingentaconnect is not responsible for the content or availability of external websites
ocean/aap/2009/00000030/00000003/art00014
dcterms_title,dcterms_description,pub_keyword
6
5
20
40
5

Access Key

Free Content
Free content
New Content
New content
Open Access Content
Open access content
Subscribed Content
Subscribed content
Free Trial Content
Free trial content
Cookie Policy
X
Cookie Policy
ingentaconnect website makes use of cookies so as to keep track of data that you have filled in. I am Happy with this Find out more