Phase 2
Completed N=26
Evaluation of the Pharmacokinetics and the Pharmacodynamics of Different Dry Powder Inhalation Formulations of AZD3199 in Patients With Asthma
Source: ClinicalTrials.gov NCT01348139 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcomePrimary: Emax: Maximum Value of FEV1 for Every Treatment Visits — 3.788; 3.784; 3.756; 3.763 Liters
Summary
The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamics of single doses of three different dry powder inhalation formulations of AZD3199 administered via Single Inhalation Device (SID) compared to AZD3199 administered via Turbuhaler™ Inhaler and compared to placebo in patients with persistent asthma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Emax: Maximum Value of FEV1 for Every Treatment Visits |
3.788; 3.784; 3.756; 3.763; 3.847; 3.498 | — |
| PRIMARY E22-26h: The Average of the FEV1 Values Between 22 and 26 h for Every Treatment Visit |
3.448; 3.453; 3.495; 3.448; 3.569; 3.310 | — |
| SECONDARY tEmax: Time to Maximum Value of FEV1 for Every Treatment Visit |
2.000; 2.000; 2.000; 1.000; 4.000; 10.000 | — |
| SECONDARY E5min: The Value of FEV1 at 5 Min for Every Treatment Visit. |
3.406; 3.449; 3.496; 3.489; 3.486; 3.188 | — |
| SECONDARY E0-24h: The Average of the FEV1 Values Between 0 and 24 h for Every Treatment Visit |
3.489; 3.526; 3.537; 3.493; 3.636; 3.287 | — |
| SECONDARY Emax: Maximum Value of Pulse for Every Treatment Visits |
66.15; 64.36; 64.24; 64.84; 66.20; 64.12 | — |
| SECONDARY E0-4h: The Average of the Pulse Values Between 0 and 4 h for Every Treatment Visit |
59.85; 59.13; 59.07; 58.77; 59.73; 58.66 | — |
| SECONDARY Cmax: Maximum Plasma Concentration |
6.93846; 5.81240; 6.29560; 3.01836; 13.54120 | — |
| SECONDARY AUC: Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC), |
21.83501; 20.21716; 22.80110; 10.25880; 37.48982 | — |
| SECONDARY Tmax:Time to Maximum Plasma Concentration |
0.47000; 0.48000; 0.52000; 0.52000; 0.48000 | — |
| SECONDARY t1/2 :Terminal Half-life |
80.97301; 79.24210; 103.7279; 77.46496; 88.99700 | — |
Eligibility Criteria
Inclusion Criteria
- Provision of signed and dated written informed consent prior to any study specific procedures
- Men or women, age ≥ 18 years. Women must be of non-childbearing potential or stable on a highly effective contraceptive method for at least 3 months prior to Visit 1 and be willing to continue on the chosen contraceptive method throughout the study.
- Be a non-smoker or ex-smoker who has stopped smoking for >6 months prior to study start
- A history of asthma for at least 6 months.
- Body Mass Index (BMI) 19-30 kg/m2
Exclusion Criteria
- Significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the result of the study, or the patient's ability to participate in the study
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to β2-agonists in general or to AZD3199 and/or excipients
- Prolonged QTcF > 450 msec or shortened QTcF <340 msec
- History of alcohol/drug abuse or excessive intake of alcohol as judged by the Investigator
- Pregnancy or lactation
Data sourced from ClinicalTrials.gov (NCT01348139). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.