Study to Evaluate Efficacy and Safety of Pulmicort Respules in Japanese Adult Asthmatic Patients

This study has been completed.

Study NCT00855959 Information provided by AstraZeneca

First Received on March 4, 2009. Last Updated on February 16, 2011 History of Changes

Results First Received: August 17, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Asthma
Interventions:	Drug: Budesonide Drug: Pulmicort Turbuhaler

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Outpatients, male and female ≥ 16 years with stable asthma

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Pulmicort Turbuhaler and Pulmicort Respules	4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily

Participant Flow: Overall Study

	Pulmicort Turbuhaler and Pulmicort Respules
STARTED	108
Patients Who Received Pulmicort Respules	105
COMPLETED	99
NOT COMPLETED	9
Adverse Event	2
Lost to Follow-up	2
Withdrawal by Subject	3
Pregnancy	1
Incorrect enrolment	1

Baseline Characteristics

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Reporting Groups

	Description
Pulmicort Turbuhaler and Pulmicort Respules	4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily

Baseline Measures

	Pulmicort Turbuhaler and Pulmicort Respules
Number of Participants [units: participants]	106
Age [units: Years] Mean ± Standard Deviation	43.9 ± 13.4
Gender [units: Participants]
Female	73
Male	33

Outcome Measures

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1. Primary:

Morning Peak Expiratory Flow (mPEF) [ Time Frame: 6 weeks ]

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2. Secondary:

Evening Peak Expiratory Flow (ePEF) [ Time Frame: 6 weeks ]

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3. Secondary:

Asthma Symptom Score (Daytime); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms) [ Time Frame: 6 weeks ]

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4. Secondary:

Asthma Symptom Score (Night-time); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms) [ Time Frame: 6 weeks ]

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5. Secondary:

Asthma Symptom Score (Total); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms) [ Time Frame: 6 weeks ]

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6. Secondary:

Use of Rescue Medication (Daytime) [ Time Frame: 6 weeks ]

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7. Secondary:

Use of Rescue Medication (Night-time) [ Time Frame: 6 weeks ]

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8. Secondary:

Use of Rescue Medication (Total) [ Time Frame: 6 weeks ]

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9. Secondary:

Night-time Awakenings Due to Asthma Symptoms [ Time Frame: 6 weeks ]

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10. Secondary:

Forced Expiratory Volume in 1 Second (FEV 1.0) [ Time Frame: 6 weeks ]

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11. Secondary:

Forced Vital Capacity (FVC) [ Time Frame: 6 weeks ]

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12. Secondary:

Number of Participants With Adverse Events (AEs) [ Time Frame: 6 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com

No publications provided

Responsible Party:	Carlsson, Lars-Goran, MD, Medical Science Director, Est.Respiratory Brands, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00855959 History of Changes
Other Study ID Numbers:	D5259C00001
Study First Received:	March 4, 2009
Results First Received:	August 17, 2010
Last Updated:	February 16, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare