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NCT00640484
Evaluation of the Effect of 2 Weeks Treatment With CHF 4226 pMDI 2µg and 4µg, Given Once Daily in the Morning, on 24-Hour FEV1 in Patients With COPD
Phase 2 trial testing carmoterol (CHF 4226) in Chronic Obstructive Pulmonary Disease in 57 participants. Completed in 1 October 2008.
1 October 2008
Quick facts
| Lead sponsor | Chiesi Farmaceutici S.p.A. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 57 |
| Start date | 1 April 2008 |
| Primary completion | 1 October 2008 |
| Estimated completion | 1 October 2008 |
| Sites | 15 locations across United States |
Drugs / interventions tested
- carmoterol (CHF 4226) — full drug profile →
- carmoterol (CHF 4226) — full drug profile →
- placebo
- salmeterol — full drug profile →
Conditions studied
- Chronic Obstructive Pulmonary Disease — all drugs for Chronic Obstructive Pulmonary Disease →
Sponsor
Chiesi Farmaceutici S.p.A. — full company profile →
Who can join
Adults 40 to 75, any sex, with Chronic Obstructive Pulmonary Disease. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
FEV1 AUC0-24 standardized by time
Time frame: on Day 15 (after 14 days of dosing)
Sponsor's own description
The purpose of this study is to confirm the dose of CHF 4226 (carmoterol) that should be given once a day to patients with COPD in order for the effect to last for 24 hours.
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 NCT00640484
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Chronic Obstructive Pulmonary Disease
Currently open trials in the same condition.
- NCT06749262 — Inclined Versus Standard Exercise for COPD Patients · NA · recruiting
- NCT07406659 — Different Inspiratory Muscle Trainings in Patients With COPD · NA · recruiting
- NCT07051707 — Evaluating the Safety and Efficacy of dNerva Lung Denervation System in Patients With COPD · NA · recruiting
- NCT07418736 — A Phase II Study of CM326 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease · Phase 2 · recruiting
- NCT07069829 — Study of Clinical and Patient-reported Outcomes in Adults With Moderate to Severe COPD Treated With Breztri/Trixeo · recruiting
Other Chiesi Farmaceutici S.p.A. trials
Trials by the same sponsor.
- NCT07516951 — A Study to Find an Efficacious and Safe Dose of CHF10067 (Zampilimab) in Participants With Idiopathic Pulmonary Fibrosis · Phase 2 · not yet recruiting
- NCT07301736 — Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma · Phase 2 · recruiting
- NCT07163182 — Evaluation of Safety, Side Effects and How the Drug CHF6467 Administered Via Intranasal Route is Absorbed, Modified and · Phase 1 · recruiting
- NCT06900816 — A Comparison Study Between Adolescents With Asthma and Adults With Asthma on How They Absorb, Metabolise and Eliminate C · Phase 2 · completed
- NCT06892756 — Effect of Cyclosporine Drug Interaction on the Absorption, Metabolism and Elimination of CHF6001 in Healthy Volunteers. · 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 NCT00640484 (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 Chiesi Farmaceutici S.p.A.
- Last refreshed: 24 August 2010
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/NCT00640484.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing