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NCT00782535
EVALUATION OF THE SAFETY AND EFFICACY OF TREATMENT WITH SINGLE DOSES OF CHF 4226 pMDI IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE A Multicenter, Randomized, Double-Blind,Placebo-Controlled, 5-Way Crossover Study
Phase 2 trial testing CHF 4226 pMDI in Chronic Obstructive Pulmonary Disease in 20 participants. Completed in 1 March 2009.
1 March 2009
Quick facts
| Lead sponsor | Chiesi Farmaceutici S.p.A. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 December 2008 |
| Primary completion | 1 March 2009 |
| Estimated completion | 1 March 2009 |
| Sites | 5 locations across United States |
Drugs / interventions tested
- CHF 4226 pMDI — full drug profile →
- CHF 4226 pMDI — full drug profile →
- Placebo
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
Time frame: T-1hr, T-10min, and 15 and 30 minutes, 1, 2, 3, 23 and 24 hours for each treatment period
Sponsor's own description
The purpose of this study is to characterize the dose-response profile of peak and trough FEV1 after single dose administrations of carmoterol in patients with COPD.
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 NCT00782535
- 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.
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- 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 NCT00782535 (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: 28 October 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/NCT00782535.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing