Erdosteine in Pulmonary Disease, Chronic Obstructive: CTRI/2026/05/110935 Clinical Landscape Report 2026
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This Clinical Landscape Report was built with PatSnap Life Sciences MCP workflows. Clinical Trials MCP supplies protocol and result records, Drug & Asset MCP adds asset context, and Company & Deal Intelligence MCP resolves sponsor background. Use the same structured MCP building blocks in your research workflow.
Data snapshot: 28 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Not Applicable
Clinical phase
Open to Recruitment
Recruitment status
120
Planned enrollment
Timing not reported
Primary-completion proxy
Executive view
CTRI/2026/05/110935 evaluates Erdosteine in Pulmonary Disease, Chronic Obstructive. The disclosed sponsor is Sponsor not reported, the design is Interventional, and the geographic footprint is India. The first listed primary endpoint is not reported, assessed over an unreported time frame.
The key landscape question is whether this protocol can generate a clinically interpretable signal relative to nearby programs. Phase alone is not a measure of evidence quality. Endpoint relevance, comparator choice, masking, enrollment feasibility, patient selection, country coverage and follow-up must be considered together.
PatSnap MCP Servers make this assessment reproducible by keeping protocol facts, result evidence, asset attributes and sponsor identity in separate structured calls.
How the MCP evidence stack was assembled
Clinical Trials MCP clinical_trial_fetch retrieved the design, outcomes, phase, status, enrollment, sponsor, countries and timing for CTRI/2026/05/110935 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Pulmonary Disease, Chronic Obstructive landscape. Drug & Asset MCP drug_fetch was queried for Erdosteine, while Company & Deal Intelligence MCP organization_fetch was queried for Sponsor not reported.
This separation reduces a common diligence error: treating a registry label, a company description or a result excerpt as if each represented the complete evidence package. Explore the source workflow at the PatSnap MCP marketplace.
Trial landscape table
| Trial | Asset / intervention | Phase / status | Sponsor | Geography | Primary endpoint | Readout proxy |
|---|---|---|---|---|---|---|
| CTRI/2026/05/110935 | Erdosteine | Not Applicable / Open to Recruitment | Sponsor not reported | India | Timing not reported |
The table aligns endpoints, sponsors, phases, geographies and readout proxies. It is descriptive, not a head-to-head efficacy comparison. Differences in population, baseline risk, intervention schedule and follow-up can dominate apparent cross-trial differences.
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Protocol design and endpoint interpretation
CTRI/2026/05/110935 is a Not Applicable, open to recruitment study with 120 planned participants. Allocation is not reported, masking is not reported, and the intervention model is not reported.
The primary endpoint is “not reported” over “not reported.” The retrieved endpoint description is: Mean change in BCSS Breathlessness Cough and Sputum Scale score Mean change in CAT COPD Assessment Test score from baseline visit V0 to End of study visit V3 Mean changes in SGRQ C from baseline V0 to V1 V2 and V3 Comparisons between the two treatment groups Erdosteine 300 mg twice daily vs Usual COPD treatment will be conducted using Independent t test for normally distributed data & Mann Whitney U test for non normally distributed data Within groups changes will be analyzed using Paired sample t test if normally distributed and Wilcoxon signed rank test if non normally distributed The average number of exacerb….
Interpretation should test whether the endpoint captures a clinically meaningful change, whether its time horizon matches the proposed biology, and whether treatment discontinuation or missing data can bias the estimate. The planned enrollment of 120 should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.
No named control drug was returned in the protocol field set. A placebo comparator can strengthen internal efficacy assessment, while an active comparator may better test clinical differentiation. Single-arm and open-label programs require greater weight on objective outcomes, independent assessment and external benchmarks.
Indexed readouts in the surrounding landscape
5 recent result records were selected as contextual evidence for Pulmonary Disease, Chronic Obstructive. These records do not establish direct evidence for CTRI/2026/05/110935 unless the registration number matches.
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Chronic Obstructive Pulmonary Disease and a Histo…
Phase 2; n=309; Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Week 12(Least Squares Mean): Adjusted Mean Difference = 5.3(95% CI, -57.0 to 67.6), P-Value = 0.8670; Adjusted Mean Difference = 12.0(95% CI, -56.4 to 80.3), P-Value = 0.7308; Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Week 12(Least Squares Mean) = -20.1 milliliters (mL) (95% C… Source: https://clinicaltrials.gov/ct2/show/results/NCT02546700
A Phase 2a, Open-label, Two-part Study to Evaluate the Mechanism of Action of Itepekimab (Anti-IL-33 mAb) on Airway Inflammation in Patients With Chronic Obstructive Pulmonary Dis…
Phase 2; n=49; Change From Baseline in Itepekimab Pharmacodynamic Normalized Enrichment Score Derived From Former Smokers in Endobronchial Biopsies in Current Smokers With Chronic Obstructive Pulmonary Disease at Week 12(Median) = 0.526 score on a scale (Full Range, -0.74 to 2.53); Change From Baseline in Itepekimab Pharmacodynamic Normalized Enrichment Score Derived From Former Smokers in Endobronchial Biopsies in Current Smokers… Source: https://clinicaltrials.gov/ct2/show/results/NCT05326412
A 12-week, Multicentre, Multinational, Randomized, Double-blind, Double-dummy, 2-arm Parallel Group Study Comparing the Efficacy and Safety of Foster® 100/6 (Beclomethasone Diprop…
Phase 3; n=419; Area Under the Curve (AUC) 0-30min Standardized by Time of Change From Pre-dose in Forced Expiratory Volume in One Second (FEV1) in the Morning of Day 1(Mean): Adjusted Mean Difference = 0.073(95% CI, 0.050 - 0.095), P-Value = <0.001; Area Under the Curve (AUC) 0-30min Standardized by Time of Change From Pre-dose in Forced Expiratory Volume in One Second (FEV1) in the Morning of Day 1(Mean) = 0.177 Liters (95% Confi… Source: https://clinicaltrials.gov/ct2/show/results/NCT01245569
Result fields should be reconciled with the source record before quantitative comparison. Population definitions, analysis sets, dose cohorts, estimands, confidence intervals, rescue therapy and follow-up can materially change the meaning of a numerical endpoint. Clinical Trials MCP supports repeatable refreshes as result records change.
Asset and sponsor context
Erdosteine is indexed as Small molecule drug with ADA biology and a global stage of Approved. The asset profile lists originator not reported as an originator or developer.
No exact Company & Deal Intelligence profile was returned for Sponsor not reported. Sponsor identity is retained from the trial protocol without adding unsupported corporate claims.
For execution diligence, monitor sponsor ownership, collaborator additions, site expansion, protocol amendments and enrollment revisions. A change in ownership or geography can alter operational confidence as well as the commercial meaning of a future readout.
Development white space
- Endpoint white space. Determine whether a more patient-relevant outcome, longer durability window or blinded central assessment would resolve uncertainty left by the current endpoint.
- Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
- Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
- Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
- Sequencing white space. Clarify whether Erdosteine is intended for monotherapy, combination, maintenance, rescue or an earlier treatment line.
White space should be framed as an unanswered development question, not merely an unoccupied mechanism label. A credible program closes a measurable clinical uncertainty with a design that can be executed and interpreted.
Strategic implications and next readouts
For sponsors, the endpoint hierarchy, safety window, enrollment pace and protocol amendment history should all support the same target product profile. Advancement criteria should be set before the readout and tied to clinical effect, uncertainty, tolerability and operational feasibility.
For business-development teams, differentiation may come from a sharper population, stronger comparator, more durable benefit, simpler delivery or clearer sequencing role. For investors, the central risk is evidence quality relative to time and capital, not the phase label in isolation.
Track recruitment status, enrollment changes, primary-completion timing, endpoint revisions, new result records, sponsor ownership and collaborator changes. Re-run the PatSnap MCP workflow when a surrogate becomes a clinical outcome, a single-country study expands, the comparator changes or a new result materially shifts the competitive benchmark.
Source trail and bottom line
Anchor trial: CTRI/2026/05/110935
Protocol source: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=153439
MCP sources: Clinical Trials MCP (clinical_trial_fetch and clinical_trial_result_fetch); Drug & Asset MCP (drug_fetch); Company & Deal Intelligence MCP (organization_fetch).
Data snapshot: 28 September 2026.
Erdosteine in Pulmonary Disease, Chronic Obstructive is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes the primary endpoint and Timing not reported the leading decision points.
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