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NCT03643874
Safety and Efficacy of Albuterol Administered by the Halix™ Dry Powder Inhaler in Subjects With Asthma
Phase 2 trial testing Halix albuterol 90 mcg in Asthma in 13 participants. Completed in 30 September 2018.
31 August 2018
Quick facts
| Lead sponsor | Concentrx Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 13 |
| Start date | 30 June 2018 |
| Primary completion | 31 August 2018 |
| Estimated completion | 30 September 2018 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Halix albuterol 90 mcg — full drug profile →
- albuterol HFA MDI 90 mcg — full drug profile →
Conditions studied
- Asthma — all drugs for Asthma →
Sponsor
Concentrx Pharmaceuticals, Inc. — full company profile →
Who can join
Adults 18 to 55, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Male and female subjects with mild to moderate asthma will be recruited to enroll in a 2-way crossover during which escalating doses of albuterol will be administered at 30 minute intervals on a single treatment day. Albuterol will be administered by the Halix albuterol unit dose disposable inhaler on one day and by Ventolin albuterol HFA MDI on the other day. Assignment to device for albuterol delivery will be by random allocation.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03643874
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Concentrx Pharmaceuticals, Inc. trials
Trials by the same sponsor.
- NCT03373409 — Safety and Pharmacokinetics of Halix(TM) Albuterol Unit Dose Disposable Inhaler Versus Albuterol MDI · Phase 1 · completed
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 NCT03643874 (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 Concentrx Pharmaceuticals, Inc.
- Last refreshed: 30 January 2019
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/NCT03643874.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing