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NCT Number: NCT01096017

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

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).

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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

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Terbutaline Turbuhaler®

Drug

0.4 mg, inhalation, single dose

Other names: Bricanyl Turbuhaler

Salbutamol pMDI

Drug

200 μg, inhalation, single dose

Other names: Saltanol

pMDI placebo pMDI

Other

Placebo pMDI 2 inhalations

Placebo Turbuhaler®

Other

Placebo Turbuhaler 1 inhalation

Primary outcomes

  1. 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.

    FEV1 (Forced Expiratory Volume in 1 second) AUC 0-4 hours after drug inhalation

Secondary outcomes

  1. 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

    percent of pre-dose (ratio)

  2. 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

    percent of pre-dose (ratio)

  3. 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

    percent of pre-dose (ratio)

  4. 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

    percent of pre-dose (ratio)

  5. 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

    percent of pre-dose (ratio)

  6. 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

    percent of pre-dose (ratio)

  7. 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

    percent of pre-dose (ratio)

  8. 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

    percent of pre-dose (ratio)

  9. 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

    Time to peak measurement of FEV1 (min)

  10. 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

    Number of patients with % change in FEV1 >15% within 4 hours after drug inhalation.

  11. 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

    Time to change more than or equal to 15% (time to onset response) within 4 hours after drug inhalation

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 30, 2010
Registry last updated
Aug 31, 2012

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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