EU Clinical Trial Information System (CTIS)

Brand Logo

Brand Logo Light

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

I searched for some studies on AstraZeneca Clinical Trials, and found these studies that may also be of interest to you.
Here is the link to my search results

Official Title

The primary objective of this study is to evaluate efficacy of AZD1981 in uncontrolled asthmatic patients on maintenance inhaled glucocorticosteroids.

One Month Dose Response Study of AZD1981 in Asthma Patients Uncontrolled on Inhaled Steroids

Research Site

A Double-blind, Randomised, Parallel Group, Multicentre Phase IIb, Placebo-Controlled, 1 Month Dose Response Study of AZD1981 in Asthma Patients Uncontrolled on Inhaled Steroids

Mean change in mPEF from baseline (mean of the 10 last days of the run-in period) to the treatment period (mean of the last 2 weeks of the treatment period)

Age Continuous

Gender, Male/Female

Mean mPEF during the treatment period (mean of the last 2 weeks of the treatment period)

The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.

Morning Peak Expiratory Flow (mPEF)

Mean ePEF during the treatment period (mean of the last 2 weeks of the treatment period)

Evening Peak Expiratory Flow (ePEF)

Mean mFEV1 during the treatment period (mean of the last 2 weeks of the treatment period)

Morning Forced Expiratory Volume in 1 second (mFEV1)

Mean eFEV1 during the treatment period (mean of the last 2 weeks of the treatment period)

Evening Forced Expiratory Volume in 1 second (eFEV1)

Mean total reliever use during the treatment period (mean of the last 2 weeks of the treatment period)

Total use of reliever

Mean night-time asthma symptom score during the treatment period (mean of the last 2 weeks of the treatment period). Scores range from 0 (none) to 3 (bad).

Night-time asthma symptom score

Mean day-time asthma symptom score during the treatment period (mean of the last 2 weeks of the treatment period). Scores range from 0 (none) to 3 (bad).

Day-time asthma symptom score

Mean percentage of awakenings due to asthma symptoms during the treatment period (mean of the last 2 weeks of the treatment period)

Awakenings

Mean percentage of asthma control days during the treatment period (mean of the last 2 weeks of the treatment period). An asthma control day is defined as a symptom-free day with no use of reliever medication during day and night. A symptom-free day is defined as a day and a night with no asthma symptoms and a day and night with no awakenings due to asthma symptoms.

Asthma control day

Mean percentage of symptom free days during the treatment period (mean of the last 2 weeks of the treatment period). A symptom-free day is defined as a day and a night with no asthma symptoms and a day and night with no awakenings due to asthma symptoms.

Symptom free day

Mean percentage of reliever free days during the treatment period (mean of the last 2 weeks of the treatment period). A reliever free day is defined as a day and a night with no use of as-needed medication.

Reliever free day

Mean FEV1 during the treatment period (mean value at Week 4)

Forced Expiratory Volume in 1 second (FEV1) at the clinic

Mean FVC during the treatment period (mean value at Week 4)

Forced Vital Capacity (FVC) at the clinic

Mean ACQ5 score during the treatment period (mean value at Week 4). Scores range from 0 (good) to 6 (poor control).

Asthma Control Questionnarie 5 items (ACQ5)

Number of patients reporting at least one event

Adverse event (AE)

Overall Study

Alison Holt 

Mean change in ePEF from baseline (mean of the 10 last days of the run-in period) to the treatment period (mean of the last 2 weeks of the treatment period)

Mean change in mFEV1 from baseline (mean of the 10 last days of the run-in period) to the treatment period (mean of the last 2 weeks of the treatment period)

Mean change in eFEV1 from baseline (mean of the 10 last days of the run-in period) to the treatment period (mean of the last 2 weeks of the treatment period)

Mean change in total reliever use from baseline (mean of the 10 last days of the run-in period) to the treatment period (mean of the last 2 weeks of the treatment period)

Mean change in night-time asthma symptom score from baseline (mean of the 10 last days of the run-in period) to the treatment period (mean of the last 2 weeks of the treatment period)

Mean change in day-time asthma symptom score from baseline (mean of the 10 last days of the run-in period) to the treatment period (mean of the last 2 weeks of the treatment period)

Mean change in awakenings from baseline (mean of the 10 last days of the run-in period) to the treatment period (mean of the last 2 weeks of the treatment period)

Mean change in asthma control day from baseline (mean of the 10 last days of the run-in period) to the treatment period (mean of the last 2 weeks of the treatment period)

Mean change in reliever free day from baseline (mean of the 10 last days of the run-in period) to the treatment period (mean of the last 2 weeks of the treatment period)

The change in FEV1 from the last measurement before treatment to the last value on treatment

The change in FVC from the last measurement before treatment to the last value on treatment

The change in overall ACQ5score from Visit 3 to the last value on treatment

Arms	Assigned Interventions
Experimental: AZD1981 50 mg AZD1981 50 mg Twice Daily (Bid)	Drug: AZD1981 Oral tablet, 50 mg twice daily
Placebo Comparator: Placebo Placebo	-
Experimental: AZD1981 400 mg AZD1981 400 mg Twice Daily (Bid)	Drug: AZD1981 Oral tablet, 400 mg twice daily
Experimental: AZD1981 1000 mg AZD1981 1000 mg Twice Daily (Bid)	Drug: AZD1981 Oral tablet, 1000 mg twice daily

One Month Dose Response Study of AZD1981 in Asthma Patients Uncontrolled on Inhaled Steroids - OLIVE

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=214&filename=CSR-D9830C00004.pdf

CSR-D9830C00004.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator