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

Authors: Nelson, Harold S.; Busse, William W.; Sanger, Mary; Cutler, Gordon; Ellwanger, Colleen; Chipman, John J.

Source: Allergy and Asthma Proceedings, Volume 30, Number 3, May-June 2009 , pp. 325-332(8)

Publisher: OceanSide Publications, Inc

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

Document Type: Research article

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

Affiliations: 1: Department of Medicine, National Jewish Health, Denver, Colorado, USA. nelsonh@njhealth.org

Publication date: 2009-05-01

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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.

The journal is indexed in Thomson Reuters Web of Science and Science Citation Index Expanded, plus the National Library of Medicine's PubMed service.
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Short-term safety of somatropin inhalation powder in adults with mild to moderate asthma

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