title: A pilot randomized controlled trial of pioglitazone for the treatment of poorly controlled asthma in obesity.
abstract: BACKGROUND
  Obese asthmatics tend to have poorly controlled asthma, and resistance to standard asthma controller medications. The purpose of this study was to determine the efficacy of pioglitazone, an anti-diabetic medication which can alter circulating adipokines and have direct effects on asthmatic inflammation, in the treatment of asthma in obesity.
  
  
  METHODS
  A two-center, 12-week, randomized, placebo-controlled, double-blinded trial. Treatments were randomly assigned with concealment of allocation. The primary outcome was difference in change in airway reactivity between participants assigned to pioglitazone versus placebo at 12 weeks.
  
  
  RESULTS
  Twenty-three participants were randomized to treatment, 19 completed the study. Median airway reactivity, measured by PC20 to methacholine was 1.99 (IQR 3.08) and 1.60 (5.91) mg/ml in placebo and pioglitazone group at baseline, and 2.37 (15.22) and 5.08 (7.42) mg/ml after 12 weeks, p = 0.38. There was no difference in exhaled nitric oxide, asthma control or lung function between treatment groups over the 12 week trial. Participants assigned to pioglitazone gained a significant amount more weight than those assigned to placebo (pioglitazone group mean weight 113.6, CI 94.5-132.7 kg at randomization and 115.9, CI 96.9-135.1 at 12 weeks; placebo mean weight 127.5, CI 108.4 - 146.6 kg at randomization and 124.5, CI 105.4 - 143.6 kg at 12 weeks; p = 0.04).
  
  
  CONCLUSIONS
  This pilot study suggests limited efficacy for pioglitazone in the treatment of poorly controlled asthma in obesity, and also the potential for harm, given the weight gain in those assigned to active treatment, and the association between increased weight and worse outcomes in asthma.
  
  
  BACKGROUND
  Clinicaltrials.gov (NCT00634036).
authors.affiliation: Division of Pulmonary and Critical Care Medicine, Given D209, 149 Beaumont Avenue, Burlington, VT, 05405, USA. Anne.dixon@uvm.edu.
authors.forename: Anne E
authors.initials: AE
authors.lastname: Dixon
authors.affiliation: University of Vermont, Burlington, VT, USA. Meena.subramanian@uvmhealth.org.
authors.forename: Meenakumari
authors.initials: M
authors.lastname: Subramanian
authors.affiliation: University of Vermont, Burlington, VT, USA. Michael.desarno@uvm.edu.
authors.forename: Michael
authors.initials: M
authors.lastname: DeSarno
authors.affiliation: University of Vermont, Burlington, VT, USA. Kendall.black@uvm.edu.
authors.forename: Kendall
authors.initials: K
authors.lastname: Black
authors.affiliation: University of Pittsburgh, Pittsburgh, PA, USA. lanelm@upmc.edu.
authors.forename: Lisa
authors.initials: L
authors.lastname: Lane
authors.affiliation: University of Pittsburgh, Pittsburgh, PA, USA. holguinf@upmc.edu.
authors.forename: Fernando
authors.initials: F
authors.lastname: Holguin
mesh_terms: D000328:Adult; D018927:Anti-Asthmatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001249:Asthma / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D016535:Bronchial Hyperreactivity / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D001985:Bronchial Provocation Tests; D016085:Bronchoconstrictor Agents / Q000008:administration & dosage; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008168:Lung / Q000187:drug effects* / Q000503:physiopathology; D008297:Male; D016210:Methacholine Chloride / Q000008:administration & dosage; D008875:Middle Aged; D009765:Obesity / Q000150:complications* / Q000175:diagnosis; D010865:Pilot Projects; D000077205:Pioglitazone; D012307:Risk Factors; D045162:Thiazolidinediones / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D014707:Vermont; D015430:Weight Gain / Q000187:drug effects
chemical_list: D018927:Anti-Asthmatic Agents; D016085:Bronchoconstrictor Agents; D045162:Thiazolidinediones; D016210:Methacholine Chloride; D000077205:Pioglitazone