To Investigate the Relative Efficacy of Terbutaline Turbuhaler® and Salbutamol Pressurized Metered Dose Inhaler (pMDI) a Single Blind Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01096017
First received: March 19, 2010
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

This is a single blind, single dose, crossover study to investigate the relative efficacy of terbutaline Turbuhaler® 0.4 mg in relation to salbutamol pressurized Metered Dose Inhaler (pMDI) 200 μg in Japanese adult asthmatic patients.The secondary objective of this study is to investigate safety of terbutaline Turbuhaler® 0.4 mg in Japanese adult asthma patients by means of adverse events (AEs) and vital signs (blood pressure, pulse rate). The subject population includes Japanese patients (16 years of age or older) with asthma who need treatment with inhaled Glucocorticosteroids (ICS).


Condition Intervention Phase
Asthma
Drug: Terbutaline Turbuhaler®
Drug: Salbutamol pMDI
Other: pMDI placebo pMDI
Other: Placebo Turbuhaler®
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Study to Investigate the Relative Efficacy of Terbutaline Turbuhaler® 0.4 mg and Salbutamol Pressurized Metered Dose Inhaler (pMDI) 200 μg - a Single Blind, Single Dose, Randomized, Crossover, Phase III Study in Japanese Adult Asthma Patients

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • FEV1 (Forced Expiratory Volume in 1 Second) Area Under Curve (AUC) 0-4 Hours After Drug Inhalation [ Time Frame: At two visits during a maximum of 15 days. FEV1 timepoints: all time points t=5, 15, 30, 60, 120, 180 and 240 minutes. ] [ Designated as safety issue: No ]
    FEV1 (Forced Expiratory Volume in 1 second) AUC 0-4 hours after drug inhalation


Secondary Outcome Measures:
  • FEV1 (Forced Expiratory Volume in 1 Second) at 5 Minutes After Inhalations of Study Drug as Percentage of Pre-dose [ Time Frame: At two visits during a maximum of 15 days ] [ Designated as safety issue: No ]
    percent of pre-dose (ratio)

  • FEV1 (Forced Expiratory Volume in 1 Second) at 15 Minutes After Inhalations of Study Drug as Percentage of Pre-dose [ Time Frame: At two visits during a maximum of 15 days ] [ Designated as safety issue: No ]
    percent of pre-dose (ratio)

  • FEV1 (Forced Expiratory Volume in 1 Second) at 30 Minutes After Inhalations of Study Drug as Percentage of Pre-dose [ Time Frame: At two visits during a maximum of 15 days ] [ Designated as safety issue: No ]
    percent of pre-dose (ratio)

  • FEV1 (Forced Expiratory Volume in 1 Second) at 60 Minutes After Inhalations of Study Drug as Percentage of Pre-dose [ Time Frame: At two visits during a maximum of 15 days ] [ Designated as safety issue: No ]
    percent of pre-dose (ratio)

  • FEV1 (Forced Expiratory Volume in 1 Second) at 120 Minutes After Inhalations of Study Drug as Percentage of Pre-dose [ Time Frame: At two visits during a maximum of 15 days ] [ Designated as safety issue: No ]
    percent of pre-dose (ratio)

  • FEV1 (Forced Expiratory Volume in 1 Second) at 180 Minutes After Inhalations of Study Drug as Percentage of Pre-dose [ Time Frame: At two visits during a maximum of 15 days ] [ Designated as safety issue: No ]
    percent of pre-dose (ratio)

  • FEV1 (Forced Expiratory Volume in 1 Second) at 240 Minutes After Inhalations of Study Drug as Percentage of Pre-dose [ Time Frame: At two visits during a maximum of 15 days ] [ Designated as safety issue: No ]
    percent of pre-dose (ratio)

  • Maximum % Change in FEV1 (Forced Expiratory Volume in 1 Second) Within 4 Hours After Drug Inhalation [ Time Frame: At two visits during a maximum of 15 days ] [ Designated as safety issue: No ]
    percent of pre-dose (ratio)

  • Time to Peak FEV1 (Forced Expiratory Volume in 1 Second) Within 4 Hours After Drug Inhalation [ Time Frame: At two visits during a maximum of 15 days ] [ Designated as safety issue: No ]
    Time to peak measurement of FEV1 (min)

  • Number of Patients With % Change in FEV1 (Forced Expiratory Volume in 1 Second) >15% Within 4 Hours After Drug Inhalation [ Time Frame: At two visits during a maximum of 15 days ] [ Designated as safety issue: No ]
    Number of patients with % change in FEV1 >15% within 4 hours after drug inhalation.

  • Time to Change More Than or Equal to 15% (Time to Onset Response) Within 4 Hours After Drug Inhalation [ Time Frame: At two visits during a maximum of 15 days ] [ Designated as safety issue: No ]
    Time to change more than or equal to 15% (time to onset response) within 4 hours after drug inhalation


Enrollment: 24
Study Start Date: March 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI ⇒salbutamol pMDI 200 μg +placebo Turbuhaler®
Drug: Terbutaline Turbuhaler®
0.4 mg, inhalation, single dose
Other Name: Bricanyl Turbuhaler
Other: pMDI placebo pMDI
Placebo pMDI 2 inhalations
Other: Placebo Turbuhaler®
Placebo Turbuhaler 1 inhalation
Experimental: 2
salbutamol pMDI 200 μg +placebo Turbuhaler® ⇒Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI
Drug: Salbutamol pMDI
200 μg, inhalation, single dose
Other Name: Saltanol
Other: pMDI placebo pMDI
Placebo pMDI 2 inhalations
Other: Placebo Turbuhaler®
Placebo Turbuhaler 1 inhalation

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • On ICS for at least 3 months from Visit 2 and with a prescribed constant dose during the 4 weeks prior to Visit 2
  • Forced Expiratory Volume in 1 Second (FEV1) of at least 50 % of predicted normal value pre-bronchodilator
  • Reversible airway obstruction according to reversibility test performed at Visit 2, defined as an increase in Forced Expiratory Volume in 1 Second (FEV1) ≥12% relative baseline at 15-30 minutes after inhalation of in total 400 μg salbutamol

Exclusion Criteria:

  • Treatment with oral, parenteral or rectal GCS (Glucocorticosteroids)within 4 weeks or depot parenteral GCS (Glucocorticosteroids) within 3 months prior to Visit 2.
  • Change in prescribed asthma medication due to exacerbation of asthma within 4 weeks prior to Visit 2 or being hospitalized due to exacerbation of asthma within 8 weeks prior to Visit 2.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01096017

Locations
Japan
Research Site
Tokyo, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Tomas Andersson, MD AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01096017     History of Changes
Other Study ID Numbers: D589LC00002
Study First Received: March 19, 2010
Results First Received: October 3, 2011
Last Updated: July 27, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
Terbutaline
Turbuhaler
Efficacy
Asthma
Japanese
salbutamol
Bricanyl

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Terbutaline
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Sympathomimetics

ClinicalTrials.gov processed this record on April 15, 2014