Summary
Cromolyn Sodium has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Asthma would be drug repurposing rather than first-in-human development. This does not mean it is approved for Asthma. ClinicalTrials.gov lists 3 registered trials linking Cromolyn Sodium to Asthma: 1 is currently recruiting; 2 have completed. The most advanced is Phase 3 (NCT00943397). The largest enrolment is 101437 participants (NCT01346852). Registration activity spans 2001 to 2024. The literature layer holds 7 publications for this pair: 1 Cochrane review, 1 systematic review and 5 clinical trial publications. Publication years run from 2003 to 2020. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Asthma ranks 642 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: 26% of childhood-onset asthma in clinical remission by adulthood; <20% adult-onset achieves sustained remission; 65% long-term remission in mild-moderate vs 16% in severe.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 48.0 (trials 10.0, literature 18.0, tier 15, approved bonus 5.0) |
| Registered trials | 3 total: 1 recruiting, 0 active / not yet recruiting, 2 completed, 0 other |
| Linked publications | 7 (5 clinical trial publications, 1 Cochrane review, 1 systematic review) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT00943397 | Extended Safety Study of Montelukast in Infants and Young Children With Chronic Asthma (0476-232) 2001 | completed | Phase 3 | 190 |
| NCT01346852 | Predictive Ability of Therapeutic Risk Factors in Pediatric and Adult Asthma Patients 2009 | completed | Not applicable | 101,437 |
| NCT06535087 | The Impact of Airway Allergic Diseases on Children's and Parents' Quality of Life 2024 | recruiting | Not applicable | 600 |
Published literature
- Systematic review Nebulized Inhaled Corticosteroids in Asthma Treatment in Children 5 Years or Younger: A Systematic Review and Global Expert AnalysisMurphy KR, Hong JG, Wandalsen G et al. · The journal of allergy and clinical immunology. In practice · 2020 · PMID 32006721
- Clinical trial publication Salivary cortisol monitoring: determination of reference values in healthy children and application in asthmatic childrenNagakura T, Tanaka T, Arita M et al. · Allergy and asthma proceedings · 2012 · PMID 22856637
- Clinical trial publication [Effects of acupuncture on the pulmonary function and heart rate variability in different state of bronchial asthma]Zhang WP · Zhen ci yan jiu = Acupuncture research · 2007 · PMID 17580440
- Cochrane review Asthma controller therapy during pregnancyGluck JC, Gluck PA · American journal of obstetrics and gynecology · 2005 · PMID 15695974
- Clinical trial publication [Lung functioning changes of asthmatic adults in treatment with cromolyn sodium and beclomethasone]Rodríguez Medina R, Gasca Bauza MR, López Durán JL et al. · Revista alergia Mexico (Tecamachalco, Puebla, Mexico : 1993) · 2004 · PMID 15794406
- Clinical trial publication Evaluation of parental preference for the treatment of asthmatic children aged 6 to 11 years with oral montelukast or inhaled cromolyn: a randomized, open-label, crossover studyBukstein DA, Bratton DL, Firriolo KM et al. · The Journal of asthma : official journal of the Association for the Care of Asthma · 2003 · PMID 14529097
- Clinical trial publication Effects of budesonide inhalation suspension compared with cromolyn sodium nebulizer solution on health status and caregiver quality of life in childhood asthmaMurphy KR, Fitzpatrick S, Cruz-Rivera M et al. · Pediatrics · 2003 · PMID 12949315
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Cromolyn Sodium approved for Asthma?
Cromolyn Sodium has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Asthma would be drug repurposing rather than first-in-human development. This does not mean it is approved for Asthma. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Cromolyn Sodium in clinical trials for Asthma?
ClinicalTrials.gov lists 3 registered trials linking Cromolyn Sodium to Asthma: 1 is currently recruiting; 2 have completed. The most advanced is Phase 3 (NCT00943397). The largest enrolment is 101437 participants (NCT01346852). Registration activity spans 2001 to 2024.
What does the evidence show for Cromolyn Sodium in Asthma?
Cromolyn Sodium has both completed registered trials and synthesis-level publications linked to Asthma. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.