PMID- 19549433
OWN - NLM
STAT- MEDLINE
DCOM- 20090810
LR  - 20161020
IS  - 1088-5412 (Print)
IS  - 1088-5412 (Linking)
VI  - 30
IP  - 3
DP  - 2009 May-Jun
TI  - Short-term safety of somatropin inhalation powder in adults with mild to moderate 
      asthma.
PG  - 325-32
LID - 10.2500/aap.2009.30.3236 [doi]
AB  - 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 (FEV(1)) 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 FEV(1) 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.
FAU - Nelson, Harold S
AU  - Nelson HS
AD  - Department of Medicine, National Jewish Health, Denver, Colorado 80206, USA. 
      nelsonh@njhealth.org
FAU - Busse, William W
AU  - Busse WW
FAU - Sanger, Mary
AU  - Sanger M
FAU - Cutler, Gordon
AU  - Cutler G
FAU - Ellwanger, Colleen
AU  - Ellwanger C
FAU - Chipman, John J
AU  - Chipman JJ
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Allergy Asthma Proc
JT  - Allergy and asthma proceedings
JID - 9603640
RN  - 0 (Bronchoconstrictor Agents)
RN  - 0 (Recombinant Proteins)
RN  - 0W5ETF9M2K (Methacholine Chloride)
RN  - 12629-01-5 (Human Growth Hormone)
SB  - IM
MH  - Administration, Inhalation
MH  - Adolescent
MH  - Adult
MH  - Asthma/*drug therapy/immunology
MH  - Bronchial Provocation Tests
MH  - Bronchoconstrictor Agents
MH  - Female
MH  - Human Growth Hormone/*administration & dosage/adverse effects
MH  - Humans
MH  - Male
MH  - Methacholine Chloride
MH  - Middle Aged
MH  - Recombinant Proteins/*administration & dosage/therapeutic use
MH  - Young Adult
EDAT- 2009/06/25 09:00
MHDA- 2009/08/11 09:00
CRDT- 2009/06/25 09:00
PHST- 2009/06/25 09:00 [entrez]
PHST- 2009/06/25 09:00 [pubmed]
PHST- 2009/08/11 09:00 [medline]
AID - 10.2500/aap.2009.30.3236 [doi]
PST - ppublish
SO  - Allergy Asthma Proc. 2009 May-Jun;30(3):325-32. doi: 10.2500/aap.2009.30.3236.