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NCT05945355: MICA
Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)
NA trial testing Pro2 - Low Dose - 40% of participant's MIP in Asthma in Children in 76 participants. Currently enrolling.
30 October 2027
Quick facts
| Lead sponsor | Duke University |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 76 |
| Start date | 1 August 2024 |
| Primary completion | 30 October 2027 |
| Estimated completion | 30 October 2027 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Pro2 - Low Dose - 40% of participant's MIP
- Pro2 - High Dose - 75% of participant's MIP
- Pro2 - SHAM - 15% of participant's MIP
Conditions studied
- Asthma in Children — all drugs for Asthma in Children →
- Obesity — all drugs for Obesity →
- Pediatric Obesity — all drugs for Pediatric Obesity →
- Pediatric Asthma — all drugs for Pediatric Asthma →
Sponsor
Duke University
Who can join
Adults 6 to 17, any sex, with Asthma in Children or Obesity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is single-center cross-sectional mechanistic study in lean and obese children with moderate-severe asthma, followed by a randomized, SHAM-controlled trial of Inspiratory Training (IT). The primary outcome is to describe the contributions of inspiratory muscle dysfunction (IMD) and Small Airway Dysfunction (SAD) to obesity-related versus non-obesity-related asthma. The study will involve training (IT) for 8 weeks at three intensity levels (SHAM, low and high). Target dose: 150 inspirations three times weekly. The population includes 6 to 17-year-old children with moderate to severe asthma and with a body mass index qualifying as normal habitus (BMI 5th to 84th CDC percentile) or obese habitus (≥95th percentile BMI and less than 170% of the 95th CDC percentile). Participants will be involved for 10 weeks. The investigators will use analysis of covariance (ANCOVA) to estimate and test the difference in mean values of baseline measures between obese and non-obese cohorts. Covariates will include age, sex (male/female), race/ethnicity, baseline asthma severity (NAEPP step 2 vs ≥3), and atopy status
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05945355
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Duke University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05945355 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Duke University
- Last refreshed: 19 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05945355.
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