Summary
Aminophylline 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 ClinicalTrials.gov lists 3 registered trials linking Aminophylline to Asthma: 1 has completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT00442338). The largest enrolment is 100 participants (NCT03296579). Registration activity spans 2007 to 2018. The literature layer holds 13 publications for this pair: 5 Cochrane reviews, 2 meta-analyses, 1 systematic review and 5 clinical trial publications. Publication years run from 2008 to 2025. 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 | 56.0 (trials 6.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 3 total: 0 recruiting, 0 active / not yet recruiting, 1 completed, 2 other |
| Linked publications | 13 (5 Cochrane reviews, 5 clinical trial publications, 2 meta-analyses, 1 systematic review) |
| Agent type | Biologic |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00442338 | Study of MK-0476 in Adult Patients With Acute Asthma (0476-334) 2007 | completed | Phase 3 | 91 |
| NCT02270827 | A Pilot Study Into Health Pre and Post Treatment With Intravenous Aminophylline and Hydrocortisone in Severe Asthmatics 2014 | terminated | Not applicable | 5 |
| NCT03296579 | Non-invasive Ventilation vs. Standard Therapy for Children Hospitalized With an Acute Exacerbation of Asthma 2018 | status unknown | Not applicable | 100 |
Published literature
- Cochrane review Use of intravenous aminophylline in addition to the standard first-line treatment in children and adolescents with an acute asthma exacerbation: a systematic review and meta-analysis of randomised controlled trialsMudawi K, Hamud A, Powell C et al. · Archives of disease in childhood · 2025 · PMID 40562458
- Meta-analysis Intravenous Bronchodilators in Pediatric Critical Asthma: A Systematic Review and Network Meta-AnalysisAbu-Sultaneh S, Miller AG, Basnet S et al. · Pediatric pulmonology · 2025 · PMID 40637351
- Meta-analysis Second-line treatment option for children aged 18 years and under with an acute severe asthma exacerbation: a systematic review and meta-analysis of randomised controlled trialsAbdelgadir IS, Mudawi K, Hamud A et al. · Archives of disease in childhood · 2025 · PMID 40562457
- Systematic review Use of ketamine in patients with refractory severe asthma exacerbations: systematic review of prospective studiesLa Via L, Sanfilippo F, Cuttone G et al. · European journal of clinical pharmacology · 2022 · PMID 36008492
- Clinical trial publication Magnesium sulfate vs aminophylline as a second line of treatment in children with severe acute asthma. Randomized clinical trialKassisse E, Jiménez J, Mayo N et al. · Andes pediatrica : revista Chilena de pediatria · 2021 · PMID 34479242
- Cochrane review Interventions for escalation of therapy for acute exacerbations of asthma in children: an overview of Cochrane ReviewsCraig SS, Dalziel SR, Powell CV et al. · The Cochrane database of systematic reviews · 2020 · PMID 32767571
- Cochrane review Guideline on management of the acute asthma attack in children by Italian Society of PediatricsIndinnimeo L, Chiappini E, Miraglia Del Giudice M et al. · Italian journal of pediatrics · 2018 · PMID 29625590
- Cochrane review Efficacy and side effects of intravenous theophylline in acute asthma: a systematic review and meta-analysisMahemuti G, Zhang H, Li J et al. · Drug design, development and therapy · 2018 · PMID 29391776
- Clinical trial publication Randomised comparison of intravenous magnesium sulphate, terbutaline and aminophylline for children with acute severe asthmaSinghi S, Grover S, Bansal A et al. · Acta paediatrica (Oslo, Norway : 1992) · 2014 · PMID 25164315
- Clinical trial publication [Clinical efficacies of inhaled corticosteroids plus theophylline in the treatment of bronchial asthma]Chen ZC, Ding JJ, Qian HY et al. · Zhonghua yi xue za zhi · 2013 · PMID 23902840
- Clinical trial publication The efficacy and tolerability of intravenous montelukast in acute asthma exacerbations in Japanese patientsAdachi M, Taniguchi H, Tohda Y et al. · The Journal of asthma : official journal of the Association for the Care of Asthma · 2012 · PMID 22742205
- Cochrane review Intravenous beta(2)-agonists versus intravenous aminophylline for acute asthmaTravers AH, Jones AP, Camargo CA Jr et al. · The Cochrane database of systematic reviews · 2012 · PMID 23235686
- Clinical trial publication [Efficacy of pulmicort suspension plus salbutamol and ipratropium bromide for management of acute asthma exacerbation in children: a comparative study]Chen ZG, Li M, Chen H et al. · Nan fang yi ke da xue xue bao = Journal of Southern Medical University · 2008 · PMID 18359717
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 Aminophylline approved for Asthma?
Aminophylline 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 Aminophylline in clinical trials for Asthma?
ClinicalTrials.gov lists 3 registered trials linking Aminophylline to Asthma: 1 has completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT00442338). The largest enrolment is 100 participants (NCT03296579). Registration activity spans 2007 to 2018.
What does the evidence show for Aminophylline in Asthma?
Aminophylline 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.