GI Motility Online

Table 2 - Prospective trials of proton pump inhibitors in asthmatics with gastroesophageal reflux disease

From the following article

Gastroesophageal reflux and asthma

Stephen J. Sontag and Susan M. Harding

GI Motility online (2006)

doi:10.1038/gimo47

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 Study dataReflux treatmentClinical end pointsPulmonary responsesComments
    Asthma symptomAsthma med useFEV1PEF 

FEV1, forced expiratory volume in 1 second; NC, _________; PEF, peak expiratory flow; PFT, NC, no change_ PFT, pulmonary function test_______.

AMeier et al., 1994105: double-blind, randomized, crossover, placebo; study of 16 adults; criteria for reflux: macroscopic esophagitis or abnormal pH testingOmeprazole 20 mg b.i.d. times 6 wks vs placebo times 6 wksPFTs——4/16 (25%) improved with >20% increase in FEV1NCThe only parameter reserved for response was FEV1; 8 of 15 pts had stricture; 6 of 15 had erosions; small number, short duration
BFord et al., 1994106: double-blind, randomized, crossover, placebo; study of 11 nocturnal asthmatic adults; criteria for reflux: abnormal pH testing or macroscopic esophagitis with or without Barrett's esophagusOmeprazole 20 mg qd times 4 wks vs placebo times 4 wksAsthma sx; PEF; asthma medsNoneNC—NCVariability in PEF between placebo and omeprazole periods was negligible, both as a group and as individual values; thus, severity of asthmas is questionable; small number, short duration
CHarding et al., 199683:open; study of 30 adults; criteria for reflux: GER Sx >2times/mo and abnormal pH testingOmeprazole 20 mg qd times 3 mo vs omeprazole 40 mg qd times 3 mo vs omeprazole 60 mg qd times 3 moAsthma sx; asthma meds FEV1; PEFImprovedImprovedImproved20/30 (67%) reduced asthma symptom by 57% 6/30 (20%) had at least 20% improvement in PEF
DTeichtahl et al., 1996107: double-blind, randomized, crossover, placebo; study of 20 adults; criteria for reflux: abnormal pH testingOmeprazole 40 mg qd times 4 wks vs placebo times 4 wksAsthma sx; PEF; asthma medsNoneNCNo changeNC14 of 20 had esophageal erosions; severe asthma and severe GER were excluded; evening PEF were statistically different on omeprazole, compared to placebo 82% vs 79%), but were (clinically the same; small number, short duration
EBoeree et al., 1998108: double-blind, randomized, placebo; study of 36 adults; criteria for reflux: abnormal pH testingOmeprazole 40 mg b.i.d. times 3 mo vs placebo b.i.d. times 3 moAsthma sx; PEF; asthma meds; bronchial activityNoneNCNCNC% variability in PEF was normal at baseline, and thus could not improve more
FLevin et al., 1998109: double-blind, randomized, crossover, placebo; study of nine adults; criteria for reflux: abnormal pH testingOmeprazole 20 mg qd times 8 wks vs placebo times 8 wksAsthma sx; FEV1; PEFImproved—NCImprovedSymptom improvement based on Asthma Quality of Life Questionnaire; trend toward significance in FEV1 on omeprazole vs placebo (16.6%)
GGonzález et al, 1998110: open; study of 28 adults; criteria for reflux: barium x-ray or esophagoscopyOmeprazole 20 mg b.i.d. vs cisaprideAsthma sx—80% stopped CompletelyImproved—Abstract only
HKiljander et al., 199922: double-blind, randomized, crossover, placebo; study of 69 adults; criteria for reflux: abnormal pH testingOmeprazole 40 mg qd times 8 wks vs placebo times 8 wksAsthma sx; PEF; asthma meds; bronchial activityImprovedNo changeImprovedNCNo improvement in daytime asthma symptoms; improvement (as a group) in nighttime asthma symptoms (with omeprazole); improvement (as a group) in FEV1 only in intrinsic asthmatics (with omeprazole); symptom score improvement in 36% of patients (with omeprazole); acid reflux on pH testing was more severe in the 36% of symptom responders
ILittner et al., 2005111: multicenter, double-blind, placebo, randomized; study of 207 adults; criteria for reflux: symptomsLansoprazole 30 mg q.i.d. times 24 wks vs placebo times 24 wksAsthma sx; quality of life; asthma meds; PFTsDecreased exacerbations; no change in daily diary sxNCNCNCNo improvement in daytime asthma symptoms; significant decreases in mild, mod, severe asthma exacerbations
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