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
Study data | Reflux treatment | Clinical end points | Pulmonary responses | Comments | ||||
---|---|---|---|---|---|---|---|---|
Asthma symptom | Asthma med use | FEV1 | PEF | |||||
FEV1, forced expiratory volume in 1 second; NC, _________; PEF, peak expiratory flow; PFT, NC, no change_ PFT, pulmonary function test_______. | ||||||||
A | Meier et al., 1994105: double-blind, randomized, crossover, placebo; study of 16 adults; criteria for reflux: macroscopic esophagitis or abnormal pH testing | Omeprazole 20 mg b.i.d. 6 wks vs placebo 6 wks | PFTs | — | — | 4/16 (25%) improved with >20% increase in FEV1 | NC | The only parameter reserved for response was FEV1; 8 of 15 pts had stricture; 6 of 15 had erosions; small number, short duration |
B | Ford 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 esophagus | Omeprazole 20 mg qd 4 wks vs placebo 4 wks | Asthma sx; PEF; asthma meds | None | NC | — | NC | Variability 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 |
C | Harding et al., 199683:open; study of 30 adults; criteria for reflux: GER Sx >2/mo and abnormal pH testing | Omeprazole 20 mg qd 3 mo vs omeprazole 40 mg qd 3 mo vs omeprazole 60 mg qd 3 mo | Asthma sx; asthma meds FEV1; PEF | Improved | Improved | Improved | 20/30 (67%) reduced asthma symptom by 57% 6/30 (20%) had at least 20% improvement in PEF | |
D | Teichtahl et al., 1996107: double-blind, randomized, crossover, placebo; study of 20 adults; criteria for reflux: abnormal pH testing | Omeprazole 40 mg qd 4 wks vs placebo 4 wks | Asthma sx; PEF; asthma meds | None | NC | No change | NC | 14 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 |
E | Boeree et al., 1998108: double-blind, randomized, placebo; study of 36 adults; criteria for reflux: abnormal pH testing | Omeprazole 40 mg b.i.d. 3 mo vs placebo b.i.d. 3 mo | Asthma sx; PEF; asthma meds; bronchial activity | None | NC | NC | NC | % variability in PEF was normal at baseline, and thus could not improve more |
F | Levin et al., 1998109: double-blind, randomized, crossover, placebo; study of nine adults; criteria for reflux: abnormal pH testing | Omeprazole 20 mg qd 8 wks vs placebo 8 wks | Asthma sx; FEV1; PEF | Improved | — | NC | Improved | Symptom improvement based on Asthma Quality of Life Questionnaire; trend toward significance in FEV1 on omeprazole vs placebo (16.6%) |
G | González et al, 1998110: open; study of 28 adults; criteria for reflux: barium x-ray or esophagoscopy | Omeprazole 20 mg b.i.d. vs cisapride | Asthma sx | — | 80% stopped Completely | Improved | — | Abstract only |
H | Kiljander et al., 199922: double-blind, randomized, crossover, placebo; study of 69 adults; criteria for reflux: abnormal pH testing | Omeprazole 40 mg qd 8 wks vs placebo 8 wks | Asthma sx; PEF; asthma meds; bronchial activity | Improved | No change | Improved | NC | No 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 |
I | Littner et al., 2005111: multicenter, double-blind, placebo, randomized; study of 207 adults; criteria for reflux: symptoms | Lansoprazole 30 mg q.i.d. 24 wks vs placebo 24 wks | Asthma sx; quality of life; asthma meds; PFTs | Decreased exacerbations; no change in daily diary sx | NC | NC | NC | No improvement in daytime asthma symptoms; significant decreases in mild, mod, severe asthma exacerbations |