Asthma (Diagnosis)NCT07507682
Can Astaxanthin Help Manage Asthma in POlluted Areas?
A study testing Astaxanthin Oral Capsule in people with Asthma (Diagnosis) and Airway Inflammation, run by Middlesex University at 1 site in United Kingdom.
Trial summary
This study will test whether astaxanthin, a naturally occurring antioxidant supplement, can improve lung function, reduce airway inflammation, and improve asthma control in adults with mild-to-moderate asthma. Participants will receive astaxanthin and placebo in random order in a double-blind crossover design. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma (Diagnosis), Airway Inflammation, Airway Hyperresponsiveness
- What is being tested?
- Astaxanthin Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 May 2026to 20 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults 18+ y
- Confirmed clinical diagnosis of mild-to-moderate asthma, defined as:
- A physician diagnosed asthma condition consistent with BTS/NICE/SIGN (2024)
- Asthma managed at GINA (2024) step 1-3 therapy level, with stable maintenance treatment for ≥4 weeks prior to enrolment
- No asthma exacerbation requiring systemic corticosteroids within the preceding 6-8 weeks
- (those with suspected Asthma will be invited to a familiarisation and eligibility session where they will have clinical investigations to assess for asthma and thus be included or excluded)
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- Ability to demonstrate acceptable and repeatable spirometry in accordance with ATS/ERS standards
- Willing to refrain from antioxidant and anti-inflammatory supplementation (e.g. Omega-3, turmeric, NSAID supplements) for the duration of the study
- Not consuming high dietary ASTX sources (e.g., frequent salmonid or crustacean intake), assessed at screening
- non-smoking and non-vaping
- Able and willing to take daily study capsules and attend all required visits
- Able and willing to complete home monitoring, including peak flow, air-quality monitoring, and questionnaires
- Able to provide written informed consent
Who cannot join
- Current smokers or vapers which is associated with chronic airway remodelling, reduce hyperresponsiveness to bronchodilators, and increased neutrophilic inflammation, which can obscure the true effects of asthma-target interventions
- Respiratory tract infection within the preceding 4 weeks
- Pregnant or lactating individuals
- Presence of significant co-morbidities, including CVD or autoimmune or systemic inflammatory diseases
- Renal or gastrointestinal disorders that may affect astaxanthin absorption and metabolism
- Known allergy or hypersensitivity to ASTX or any components of the study supplement
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- History of current evidence of alcohol or substance abuse
- Participation in another interventional drug or supplement study within the preceding 3 months
- Use of medicines with a narrow therapeutic index where supplement interactions may pose risk (e.g., ciclosporin/tacrolimus, warfarin), assessed by investigator
- Other significant chronic respiratory disease (e.g., COPD, bronchiectasis)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dr Lygeri Dimitriou contact
United Kingdom1 site, 1 recruiting
- Recruiting
Middlesex University
London, Barnet, NW4 4BT
About this study
Official title: Investigating Astaxanthin as a Novel Therapy for Asthma Management in Polluted Environments
This study will test whether astaxanthin, a naturally occurring antioxidant supplement, can improve lung function, reduce airway inflammation, and improve asthma control in adults with mild-to-moderate asthma. Participants will receive astaxanthin and placebo in random order in a double-blind crossover design. Each treatment period lasts 4 weeks and is separated by a 3-week washout period. The study also measures indoor and personal air pollution exposure to examine whether pollution influences asthma symptoms, airway responsiveness, and response to treatment. Exploratory thoracic bioelectrical impedance spectroscopy will be assessed alongside standard respiratory tests.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, 2-sequence, 2-period crossover trial in 25 non-smoking, non-vaping adults aged 18 to 59 years with mild-to-moderate asthma or asthma-like symptoms confirmed at screening. Participants will be allocated 1:1 to one of two treatment sequences: astaxanthin followed by placebo, or placebo followed by astaxanthin. Each intervention period lasts 4 weeks and is separated by a 3-week washout. Astaxanthin will be given orally at a total dose of 12 mg/day as three 4 mg capsules taken with the participant's largest meal; placebo capsules will be matched. Outcome assessments include FeNO, spirometry, impulse oscillometry, body plethysmography, hypertonic saline challenge with induced sputum collection, home peak expiratory flow monitoring, questionnaires, and exploratory thoracic bioelectrical impedance spectroscopy. Indoor and personal air pollution exposures will be measured throughout the study to evaluate whether pollution modifies respiratory outcomes and treatment response.
- Being tested
- Astaxanthin Oral Capsule, Matched Placebo (Capsules)
- Keywords
- Astaxanthin, Mild-to-Moderate Asthma, Air Pollution, FeNO, Hypertonic Saline Challenge, Impulse Oscillometry, Thoracic Bioelectrical Impedance Spectroscopy
- Medical subject headings
- Asthma, Disease, Respiratory Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Astaxanthin Oral CapsuleDietary supplement
Natural astaxanthin derived primarily from Haematococcus pluvialis, administered orally as three 4 mg capsules daily (total 12 mg/day) with the participant's largest meal for 4
Matched Placebo (Capsules)Dietary supplement
Matched placebo capsules administered orally once daily as three capsules with the participant's largest meal for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Sequence A: Astaxanthin Then Placebo | Experimental | Participants receive astaxanthin 12 mg/day orally for 4 weeks, followed by a 3-week washout, then matched placebo orally for 4 weeks. Receives: Dietary Supplement: Astaxanthin Oral Capsule; Dietary Supplement: Matched Placebo (Capsules) |
| Sequence B: Placebo Then Astaxanthin | Experimental | Participants receive matched placebo orally for 4 weeks, followed by a 3-week washout, then astaxanthin 12 mg/day orally for 4 weeks. Receives: Dietary Supplement: Astaxanthin Oral Capsule; Dietary Supplement: Matched Placebo (Capsules) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Forced Expiratory Volume in 1 Second (FEV1)
FEV1 measured by spirometry using a calibrated Medisoft BodyBox system. Comparison is within-participant change after astaxanthin versus placebo.
Measured: Measured at period-specific baseline and restablishment of baseline after washout period and end of each 4-week treatment period
Change in Fractional Exhaled Nitric Oxide (FeNO)
FeNO measured in parts per billion using the NIOX VERO analyser. Comparison is within-participant change after astaxanthin versus placebo.
Measured: Measured at period-specific baseline and restablishment of baseline after washout period and end of each 4-week treatment period
Change in Airway Hyperresponsiveness During Hypertonic Saline Challenge
Hypertonic saline challenge response quantified using the dose response slope
Measured: Measured at period-specific baseline and end of each 4-week treatment period
Secondary outcomes (7)
Change in Impulse Oscillometry Resistance at 5 Hz (R5)
R5 measured during tidal breathing using the PulmoScan system
Measured: Baseline, end of phase 1, post washout and end of phase 2
Change in Impulse Oscillometry Area of Reactance (AX)
AX measured using the PulmoScan system as an index of peripheral airway involvement.
Measured: Baseline, end of phase 1, post washout and end of phase 2
Change in Asthma Control Questionnaire-6 (ACQ-6) Total Score
Participant-reported asthma control measured using the ACQ-6.
Measured: Weekly during the 11- to 12-week study period
Change in Asthma Quality of Life Questionnaire (AQLQ) Total Score
Every 2 weeks during the 11- to 12-week study period
Measured: Participant-reported asthma-related quality of life measured using the AQLQ.
Change in Peak Expiratory Flow Amplitude Percent Mean (PEF APM)
Diurnal variability in peak expiratory flow derived from home morning and evening PEF
Measured: Twice daily during each treatment period and washout, up to 11 to 12 weeks
Change in Sputum Eosinophil Percentage
Baseline, end of phase 1, post washout period and end of phase 2
Measured: Induced sputum cellular differential measured after hypertonic saline challenge.
Change in Sputum Interleukin-8 (IL-8) Concentration
Baseline, end of phase 1, post washout and end of phase 2
Measured: IL-8 measured in processed induced sputum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start15 May 2026 (estimated)
- Primary completion20 Jul 2026 (estimated)
- Study completion20 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Two-sequence, two-period crossover design. Participants are randomized 1:1 to Sequence A (astaxanthin then placebo) or Sequence B (placebo then astaxanthin). Each treatment period lasts 4 weeks and is separated by a 3-week washout period.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Middlesex University
- Sponsor type
- University, hospital or other
- Collaborators
- AstaReal, BodyStat Ltd., British Pest Control Association
- Responsible party
- Principal investigator, Ahmet N Celen, Middlesex University
- Investigators
- Lygeri Dimitriou, Study director, Middlesex University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507682
- Sponsor's protocol ID
- Ethics application ETH2425-008
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Astaxanthin as a Novel Therapy for Asthma Management in Polluted Environments
- ClinicalTrials.gov ID
- NCT07507682
- Acronym / sponsor ID
- Ethics application ETH2425-008
- Keywords
- Astaxanthin, Mild-to-Moderate Asthma, Air Pollution, FeNO, Hypertonic Saline Challenge, Impulse Oscillometry, Thoracic Bioelectrical Impedance Spectroscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Middlesex UniversityUniversity, hospital or other
- Collaborators
- AstaReal, BodyStat Ltd., British Pest Control Association
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 20 Jul 2026 (estimated)
- Study completion
- 20 Jul 2026 (estimated)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test whether astaxanthin, a naturally occurring antioxidant supplement, can improve lung function, reduce airway inflammation, and improve asthma control in adults with mild-to-moderate asthma. Participants will receive astaxanthin and placebo in random order in a double-blind crossover design. Each treatment period lasts 4 weeks and is separated by a 3-week washout period. The study also measures indoor and personal air pollution exposure to examine whether pollution influences asthma symptoms, airway responsiveness, and response to treatment. Exploratory thoracic bioelectrical impedance spectroscopy will be assessed alongside standard respiratory tests.
Detailed description
This is a randomized, double-blind, placebo-controlled, 2-sequence, 2-period crossover trial in 25 non-smoking, non-vaping adults aged 18 to 59 years with mild-to-moderate asthma or asthma-like symptoms confirmed at screening. Participants will be allocated 1:1 to one of two treatment sequences: astaxanthin followed by placebo, or placebo followed by astaxanthin. Each intervention period lasts 4 weeks and is separated by a 3-week washout. Astaxanthin will be given orally at a total dose of 12 mg/day as three 4 mg capsules taken with the participant's largest meal; placebo capsules will be matched. Outcome assessments include FeNO, spirometry, impulse oscillometry, body plethysmography, hypertonic saline challenge with induced sputum collection, home peak expiratory flow monitoring, questionnaires, and exploratory thoracic bioelectrical impedance spectroscopy. Indoor and personal air pollution exposures will be measured throughout the study to evaluate whether pollution modifies respiratory outcomes and treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-sequence, two-period crossover design. Participants are randomized 1:1 to Sequence A (astaxanthin then placebo) or Sequence B (placebo then astaxanthin). Each treatment period lasts 4 weeks and is separated by a 3-week washout period.
| Arm | Type | Receives |
|---|---|---|
| Sequence A: Astaxanthin Then Placebo | Experimental | Dietary Supplement: Astaxanthin Oral Capsule, Dietary Supplement: Matched Placebo (Capsules)Participants receive astaxanthin 12 mg/day orally for 4 weeks, followed by a 3-week washout, then matched placebo orally for 4 weeks. |
| Sequence B: Placebo Then Astaxanthin | Experimental | Dietary Supplement: Astaxanthin Oral Capsule, Dietary Supplement: Matched Placebo (Capsules)Participants receive matched placebo orally for 4 weeks, followed by a 3-week washout, then astaxanthin 12 mg/day orally for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Adults 18+ y
- Confirmed clinical diagnosis of mild-to-moderate asthma, defined as:
- (those with suspected Asthma will be invited to a familiarisation and eligibility session where they will have clinical investigations to assess for asthma and thus be included or excluded)
- Ability to demonstrate acceptable and repeatable spirometry in accordance with ATS/ERS standards
- Willing to refrain from antioxidant and anti-inflammatory supplementation (e.g. Omega-3, turmeric, NSAID supplements) for the duration of the study
Key exclusion criteria (10 listed)
- Current smokers or vapers which is associated with chronic airway remodelling, reduce hyperresponsiveness to bronchodilators, and increased neutrophilic inflammation, which can obscure the true effects of asthma-target interventions
- Respiratory tract infection within the preceding 4 weeks
- Pregnant or lactating individuals
- Presence of significant co-morbidities, including CVD or autoimmune or systemic inflammatory diseases
- Renal or gastrointestinal disorders that may affect astaxanthin absorption and metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Astaxanthin Oral CapsuleNatural astaxanthin derived primarily from Haematococcus pluvialis, administered orally as three 4 mg capsules daily (total 12 mg/day) with the participant's largest meal for 4 | Dietary supplement | Sequence A: Astaxanthin Then Placebo, Sequence B: Placebo Then Astaxanthin |
| Matched Placebo (Capsules)Matched placebo capsules administered orally once daily as three capsules with the participant's largest meal for 4 weeks. | Dietary supplement | Sequence A: Astaxanthin Then Placebo, Sequence B: Placebo Then Astaxanthin |
Primary outcome
Change in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Measured at period-specific baseline and restablishment of baseline after washout period and end of each 4-week treatment period
FEV1 measured by spirometry using a calibrated Medisoft BodyBox system. Comparison is within-participant change after astaxanthin versus placebo.
Change in Fractional Exhaled Nitric Oxide (FeNO)
Time frame: Measured at period-specific baseline and restablishment of baseline after washout period and end of each 4-week treatment period
FeNO measured in parts per billion using the NIOX VERO analyser. Comparison is within-participant change after astaxanthin versus placebo.
Change in Airway Hyperresponsiveness During Hypertonic Saline Challenge
Time frame: Measured at period-specific baseline and end of each 4-week treatment period
Hypertonic saline challenge response quantified using the dose response slope
7 secondary outcomes
Change in Impulse Oscillometry Resistance at 5 Hz (R5)
Time frame: Baseline, end of phase 1, post washout and end of phase 2
Change in Impulse Oscillometry Area of Reactance (AX)
Time frame: Baseline, end of phase 1, post washout and end of phase 2
Change in Asthma Control Questionnaire-6 (ACQ-6) Total Score
Time frame: Weekly during the 11- to 12-week study period
Change in Asthma Quality of Life Questionnaire (AQLQ) Total Score
Time frame: Participant-reported asthma-related quality of life measured using the AQLQ.
Change in Peak Expiratory Flow Amplitude Percent Mean (PEF APM)
Time frame: Twice daily during each treatment period and washout, up to 11 to 12 weeks
Change in Sputum Eosinophil Percentage
Time frame: Induced sputum cellular differential measured after hypertonic saline challenge.
Change in Sputum Interleukin-8 (IL-8) Concentration
Time frame: IL-8 measured in processed induced sputum.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr Lygeri Dimitriou contact
Lygeri Dimitriou study director
Middlesex University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Astaxanthin Oral Capsule in people with Asthma (Diagnosis) and Airway Inflammation, run by Middlesex University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmet Celen, PhD in Biomedical Science (+447840475597, AC1534@live.mdx.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Forced Expiratory Volume in 1 Second (FEV1) (time frame: Measured at period-specific baseline and restablishment of baseline after washout period and end of each 4-week treatment period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.