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NCT Number: NCT01348139

Evaluation of the Pharmacokinetics and the Pharmacodynamics of Different Dry Powder Inhalation Formulations of AZD3199 in Patients With Asthma

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Gothenburg, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD3199

Drug

Inhaled via single inhaler device (SID)

AZD3199 Placebo

Other

Inhaled via Turbuhaler inhaler and SID

Primary outcomes

  1. Emax: Maximum Value of FEV1 for Every Treatment Visits

    Time frame: 0-24 hrs

    Peak effect (Emax) within 0-24 hours of FEV1, for treatment visits 2 to 7.

  2. E22-26h: The Average of the FEV1 Values Between 22 and 26 h for Every Treatment Visit

    Time frame: 22-26 hrs.

    Trough effect (E22-26h) will be computed from the repeated measurements collected after each single dose during 22-26 hours of FEV1 from visit 2 to 7.

Secondary outcomes

  1. tEmax: Time to Maximum Value of FEV1 for Every Treatment Visit

    Time frame: 0 - 24 hrs.

    Time to peak effect (tEmax), within 0-24 hours of FEV1, for treatment visits 2 to 7.

  2. E5min: The Value of FEV1 at 5 Min for Every Treatment Visit.

    Time frame: FEV1 at 5 min

    Onset of effect (E5min), observed at 5 min. FEV1 for treatment visits 2 to 7.

  3. E0-24h: The Average of the FEV1 Values Between 0 and 24 h for Every Treatment Visit

    Time frame: 0 - 24 hrs

    Average effect over 0-24 hours of FEV1 (E0-24h), for treatment visits 2 to 7.

  4. Emax: Maximum Value of Pulse for Every Treatment Visits

    Time frame: 0 - 4 hrs.

    Peak effect (Emax) within 0-4 hours of pulse, for treatment visits 2 to 7.

  5. E0-4h: The Average of the Pulse Values Between 0 and 4 h for Every Treatment Visit

    Time frame: 0 - 4 hrs.

    Average effect (E0-4h) of Pulse, for treatment visits 2 to 7.

  6. Cmax: Maximum Plasma Concentration

    Time frame: 0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.

    Maximum plasma concentration (Cmax) for AZD3199 doses

  7. AUC: Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC),

    Time frame: 0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.

    Area under the plasma concentration-time curve from zero to infinity (AUC), for AZD3199 doses

  8. Tmax:Time to Maximum Plasma Concentration

    Time frame: 0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.

    Time to maximum plasma concentration (tmax), for AZD3199 doses

  9. t1/2 :Terminal Half-life

    Time frame: 0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.

    Terminal half-life (t1/2),for AZD3199 doses

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Randomised, Double-blind, Double-dummy, Placebo-controlled, Multicentre, 6-way Crossover, Single-dose, Phase IIa Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Different Dry Powder Inhalation Formulations of AZD3199 Administered Via Single Inhalation Device Compared to AZD3199 Administered Via Turbuhaler™ Inhaler in Patients With Asthma

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 5, 2011
Registry last updated
Mar 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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