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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01096017

Enrollment

Registered

2010-03-30

Start date

2010-03-31

Completion date

2010-04-30

Last updated

2012-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Terbutaline, Turbuhaler, Efficacy, Asthma, Japanese, salbutamol, Bricanyl

Brief summary

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).

Interventions

DRUGTerbutaline Turbuhaler®

0.4 mg, inhalation, single dose

DRUGSalbutamol pMDI

200 μg, inhalation, single dose

OTHERpMDI placebo pMDI

Placebo pMDI 2 inhalations

OTHERPlacebo Turbuhaler®

Placebo Turbuhaler 1 inhalation

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
FEV1 (Forced Expiratory Volume in 1 Second) Area Under Curve (AUC) 0-4 Hours After Drug Inhalation	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

Measure	Time frame	Description
FEV1 (Forced Expiratory Volume in 1 Second) at 30 Minutes After Inhalations of Study Drug as Percentage of Pre-dose	At two visits during a maximum of 15 days	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	At two visits during a maximum of 15 days	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	At two visits during a maximum of 15 days	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	At two visits during a maximum of 15 days	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	At two visits during a maximum of 15 days	percent of pre-dose (ratio)
Maximum % Change in FEV1 (Forced Expiratory Volume in 1 Second) Within 4 Hours After Drug Inhalation	At two visits during a maximum of 15 days	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	At two visits during a maximum of 15 days	percent of pre-dose (ratio)
Time to Peak FEV1 (Forced Expiratory Volume in 1 Second) Within 4 Hours After Drug Inhalation	At two visits during a maximum of 15 days	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	At two visits during a maximum of 15 days	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	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
FEV1 (Forced Expiratory Volume in 1 Second) at 5 Minutes After Inhalations of Study Drug as Percentage of Pre-dose	At two visits during a maximum of 15 days	percent of pre-dose (ratio)

Countries

Japan

Participant flow

Recruitment details

Participants recruited at one clinic in Tokyo, Japan, between March and April 2010

Pre-assignment details

37 participants enrolled; 13 excluded (9 due to eligibility criteria not fulfilled and 4 for other reasons)

Participants by arm

Arm	Count
All Study Participants	24
Total	24

Withdrawals & dropouts

Period	Reason	FG000	FG001
Treatment Period 2	Eligibility criteria not fulfilled	1	1

Baseline characteristics

Characteristic	All Study Participants
Age Continuous	41.7 Years STANDARD_DEVIATION 7.4
Sex: Female, Male Female	17 Participants
Sex: Female, Male Male	7 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 23	0 / 23
serious Total, serious adverse events	0 / 23	0 / 23

Outcome results

Primary

FEV1 (Forced Expiratory Volume in 1 Second) Area Under Curve (AUC) 0-4 Hours After Drug Inhalation

FEV1 (Forced Expiratory Volume in 1 second) 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.

Arm	Measure	Value (GEOMETRIC_MEAN)
Salbutamol pMDI	FEV1 (Forced Expiratory Volume in 1 Second) Area Under Curve (AUC) 0-4 Hours After Drug Inhalation	617.56 milliLiters x minutes
Terbutaline Turbuhaler®	FEV1 (Forced Expiratory Volume in 1 Second) Area Under Curve (AUC) 0-4 Hours After Drug Inhalation	634.64 milliLiters x minutes

Secondary