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Updated June 2026 · ClinicalTrials.gov

Phase 3 Asthma Trials

Reviewed by TrialFinderData Editorial Team · Updated

12 Phase 3 trials for Asthma, the final stage before a treatment can be submitted for FDA approval.

12 Phase 3 clinical trials for Asthma are registered on ClinicalTrials.gov. Phase 3 is the final stage of testing before a treatment can be submitted for FDA approval, and the trials below come directly from the federal registry. Always talk to your doctor before contacting a study site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

What Phase 3 Means for Asthma

Phase 3 trials are the largest and most expensive stage of clinical research before potential FDA approval. For Asthma, a Phase 3 protocol typically enrolls several hundred to several thousand patients across many medical centers, randomizes participants between the investigational treatment and either a placebo or current standard of care (where ethically appropriate), and tracks them for months or years to confirm that the treatment is both effective and safe in a real-world patient population.

12 Phase 3 trials for Asthma are currently registered. Conditions in this range often have a focused research agenda with a small number of late-stage candidates, frequently targeting a specific subpopulation or stage of the disease.

AstraZeneca (3), Professor Klaus Bønnelykke (2), Sanofi (1) lead the Phase 3 Asthma sponsor list. The blend of industry, academic, and government sponsors on a condition's Phase 3 list is a useful signal of how broadly the research community is engaged with the disease.

Phase 3 Asthma Trials on ClinicalTrials.gov

RECRUITINGPhase 3NCT06471257

A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma

An event-driven, Phase III study to evaluate the efficacy and safety of BDA MDI compared with AS MDI in reducing the risk of a severe asthma exacerbation in symptomatic Chinese...

Sponsor: AstraZenecaEnrolling: 79020 locations
RECRUITINGPhase 3NCT06560255

Fish Oil in pREgnancY for Personalized Prevention of Early Childhood Asthma

The overall aim of the study is to develop a nutritional preventive fish oil supplementation strategy in pregnancy for early childhood asthma/persistent wheeze during the first...

Sponsor: Professor Klaus BønnelykkeEnrolling: 20001 location
RECRUITINGPhase 3NCT06191315

Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY...

This is a parallel, Phase 3, 2-arm study to evaluate the efficacy and long-term safety of dupilumab treatment in children 2 to \<6 years of age with uncontrolled asthma and/or...

Sponsor: SanofiEnrolling: 9020 locations
RECRUITINGPhase 3NCT06750289

Randomised Clinical Trial to Investigate Efficacy and Safety of Benralizumab 30 mg SC as an add-on Therapy in...

This study evaluates the efficacy and safety of benralizumab as an add-on therapy in uncontrolled eosinophilic asthma participants treated with medium-dose ICS-LABA compared to...

Sponsor: AstraZenecaEnrolling: 40020 locations
RECRUITINGPhase 3NCT05757102

A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma

The primary purpose of this study is to evaluate the effects of Fluticasone Furoate (FF)/ Umeclidinium (UMEC)/ Vilanterol (VI) on lung function compared with FF/VI after 24 weeks...

Sponsor: GlaxoSmithKlineEnrolling: 29220 locations
RECRUITINGPhase 3NCT05562466

A Study to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate/Mometasone Furoate) Versus Budesonide in...

The purpose of this study is to evaluate the superiority in terms of efficacy and evaluate the safety of QMF149 (indacaterol (acetate) / mometasone (furoate)) compared to...

Sponsor: Novartis PharmaceuticalsEnrolling: 20020 locations
RECRUITINGPhase 3NCT04891237

Efficacy and Safety Evaluation for the Treatment of Allergy Against Grass and Olive Pollen

Prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial of efficacy and safety with subcutaneous immunotherapy in patients with mild to moderate...

Sponsor: Inmunotek S.L.Enrolling: 18020 locations
RECRUITINGPhase 3NCT06570889

VItamin D in pregnanCy for prevenTion Of eaRlY Childhood Asthma

The overall aim of the study is to develop a nutritional preventive vitamin D supplementation strategy in pregnancy for early childhood asthma/persistent wheeze during the first...

Sponsor: Professor Klaus BønnelykkeEnrolling: 20001 location
RECRUITINGPhase 3NCT07168473

Study to Evaluate the Efficacy and Safety of DW1807 in Perennial Allergic Rhinitis Patients With Asthma

This study aims to compare the efficacy and safety of DW1807 and DW1807-R2 in patients with perennial allergic rhinitis and comorbid asthma. The primary objective is to...

Sponsor: Daewon Pharmaceutical Co., Ltd.Enrolling: 2741 location
RECRUITINGPhase 3NCT07359846

A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-2)

The objective of this study is to assess the potential for GB-0895 treatment to improve the health of adolescents and adults with severe asthma that is uncontrolled by inhaled...

Sponsor: Generate BiomedicinesEnrolling: 78614 locations
RECRUITINGPhase 3NCT06429475

Anti-Inflammatory Reliever South Africa

This is a Phase 3 single-centre open label randomised controlled trial with two equal sized groups to assess the efficacy of budesonide/formoterol 80/4.5 (6-11 years) and 160/4.5...

Sponsor: University of KwaZuluEnrolling: 10382 locations
RECRUITINGPhase 3NCT07363642

Phase 3b Study in Patients With Severe Asthma Treated With Tezepelumab

This study aims to explore the potential for Tezepelumab-treated severe asthmatic patients to effectively and safely reduce their background maintenance medication while...

Sponsor: AstraZenecaEnrolling: 40020 locations

What Participation Looks Like

Phase 3 trials for Asthma typically enroll several hundred to several thousand participants across multiple sites. Participation involves a screening visit to confirm eligibility, randomization to either the investigational treatment or a comparator (often the current standard of care), regular study visits over months or years, and follow-up after the active treatment period. The protocols, time commitments, and visit schedules differ from trial to trial — read the per-trial page for the specifics before discussing participation with your doctor.

Each trial begins with informed consent and a screening visit, where the study team confirms eligibility against the inclusion and exclusion criteria. Randomization assigns participants to either the investigational treatment or a comparator. Standard-of-care portions of the protocol are typically billed to insurance; trial-specific procedures (extra imaging, biopsies, lab draws beyond standard care) are usually covered by the sponsor. Read each trial\'s detailed page for its specific time commitment and visit schedule.

Authoritative Resources for Asthma Trials

Verify any individual trial directly on ClinicalTrials.gov. For the federal context on how Phase 3 results feed into approval decisions, see the FDA drug approval process. For oncology-specific trial resources, the National Cancer Institute publishes patient-oriented overviews. For trials registered outside the U.S., the WHO ICTRP aggregates registries from around the world.

Frequently Asked Questions

What is a Phase 3 Asthma trial?

A Phase 3 trial is the final stage of clinical testing before a treatment can be submitted to the FDA for approval. For Asthma, Phase 3 studies typically enroll hundreds to thousands of patients across multiple medical centers, comparing the new treatment to the current standard of care or a placebo (where ethically appropriate). The goal is to confirm efficacy, monitor side effects in a larger population, and generate the evidence the FDA needs to make an approval decision.

How many Phase 3 Asthma trials are recruiting?

12 Phase 3 trials for Asthma are currently registered on ClinicalTrials.gov. Recruitment status varies by trial — some are actively enrolling, some have closed enrollment but are still in the active treatment phase, and some are completing follow-up. Click any trial below to see its current status, eligibility criteria, and contact information.

Who can participate in a Phase 3 Asthma trial?

Phase 3 eligibility depends entirely on the specific trial protocol. Each trial sets its own inclusion criteria (typically a confirmed diagnosis, certain disease stage or severity, age range) and exclusion criteria (often previous treatments, comorbidities, lab values that fall outside set ranges). The trial pages on this site translate the clinical eligibility criteria into plain English alongside the original text. Whether you fit any specific trial is a medical decision your doctor needs to confirm.

Is participating in a Phase 3 Asthma trial safe?

Phase 3 trials use treatments that have already passed Phase 1 (safety in small groups) and Phase 2 (initial efficacy and side-effect monitoring), so the safety profile is better understood than in earlier-phase studies. That said, side effects can still emerge in larger populations, and the trial protocol may require additional procedures (lab draws, imaging, biopsies) beyond standard care. The informed consent document for any specific trial details the known risks. Discuss those risks with your physician before deciding whether to participate.

Where does this trial data come from?

All trial data is sourced from the ClinicalTrials.gov API v2, the federal registry maintained by the National Library of Medicine at NIH. Under FDAAA 801, most U.S. drug and device trials must register on ClinicalTrials.gov, making it the most comprehensive source of trial information. Sponsors are required to update trial status within 30 days of a change, but delays occur — always confirm the current status with the trial site before traveling for screening.

How This Page Is Built

The trial list is filtered to ClinicalTrials.gov registrations whose phase field includes Phase 3 and whose condition list includes Asthma. Trial counts and the sponsor leaderboard are computed from the same record set. Plain-English eligibility translations on each linked trial page preserve the original clinical text alongside the accessible version. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2, maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData, Phase 3 Asthma list, June 2026. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · 12 Phase 3 trials tracked for Asthma.