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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.

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Official Title

Budesonide pMDI 160 ug bid (80 ug x 2 inhalations bid)

This purpose of the study is to investigate if budesonide pMDI 160 �g twice a day during 6 weeks is effective and safe in treating asthmatic children aged 6 to <12 years

A 6-week study in asthmatic  children aged 6 to <12 yrs comparing budesonide pMDI 160ug twice daily with placebo

Phase 2, double-blind, randomized, parallel-group, placebo-controlled, multicenter study, comparing budesonide pMDI 160 �g bid with placebo: a 6-week efficacy and safety study in children aged 6 to <12 years with asthma

Research Site

Phase 2, double-blind, randomized, parallel-group, placebo-controlled, multicenter study, comparing budesonide pMDI 160 ug bid with placebo: a 6-week efficacy and safety study in children aged 6 to <12 years with asthma

Age Continuous

Age, Customized

Gender, Male/Female

Race/Ethnicity, Customized

Forced expiratory volume in 1 second (FEV1)

Study Specific Characteristic

The peak expiratory flow rate is the maximal rate that a person can exhale during a short maximal expiratory effort after a full inspiration.  Baseline was calculated using the mean of the data recorded during the last 7 days of the run-in period, and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.

Change from baseline to treatment period average was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, age group (<8 years and ≥8 years of age) and country with baseline as a covariate.

The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.

Change in morning peak expiratory flow (PEF) from baseline to the treatment period average

FEV1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.

Change in Forced expiratory volume in 1 second (FEV1) from baseline to treatment period average

The peak expiratory flow rate is the maximal rate that a person can exhale during a short maximal expiratory effort after a full inspiration. Baseline was calculated using the mean of the data recorded during the last 7 days of the run-in period, and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.

Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (<8 years and ≥8 years of age) and country with baseline as a covariate.

Change in evening PEF from baseline to the treatment period average

FVC is the total volume of air expired after a full inspiration.  Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.
						

Change in forced vital capacity (FVC) from baseline to treatment period average

FEF25-75 is the average rate of airflow during the midportion of the forced vital capacity.  Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.

Change in forced mid-expiratory flow between 25% and 75% of the FVC (FEF25-75) from baseline to treatment period average

Daytime asthma symptom score

Total asthma symptom score

Patients, with the help of their caregiver, were required to rate and document their asthma symptoms twice daily as an overall symptom score for the time period since their previous recording. The following rating scales were used: 0 = None; no symptoms of asthma; 1 = Mild symptoms; awareness of asthma symptoms and/or signs that are easily tolerated; 2 = Moderate symptoms, asthma symptoms with some discomfort, causing some interference with daily activities or sleep; 3 = Severe symptoms; incapacitating asthma symptoms and/or signs, with inability to perform daily activities or to sleep.

Change in total daily and daytime asthma symptom scores from baseline to treatment period average

Change in nighttime asthma symptom score from baseline to treatment period average

Nighttime awakenings

Nighttime awakenings with reliever use

Patients, with the help of their caregiver, were asked to respond to a standard question each morning as they completed their eDiary. The question to be answered was, “Did your asthma cause you to wake-up last night?” If yes, patients were asked, “Did you need to use your reliever medication (albuterol/salbutamol inhaler) before you went back to sleep?”

Change in nighttime awakenings and nighttime awakenings with reliever medication use from baseline to treatment period average

Daytime reliever medication use

Total reliever medication use

The patient, with the help of their caregiver, recorded the number of inhalations of reliever medication used, for relief of asthma symptoms, twice daily in the eDiary. Patients were asked to respond to a standard question twice daily (morning and evening). The question to be answered was, “How many albuterol/salbutamol inhalations since last diary entry?”

Change in total daily and daytime reliever medication use from baseline to treatment period average

Change in nighttime reliever medication use from baseline to treatment period average

Patients were considered to have experienced a “pre-defined asthma event” if any of the following conditions were met during the study: 1. At each visit or follow-up visit, a decrease in morning pre-dose FEV1 >=20% from the Visit 3 (randomization visit) morning pre-dose FEV1 or a decrease to <65% of predicted normal value; 2. The use of >=8 actuations of albuterol/salbutamol per day on 3 or more days within any period of 7 consecutive days following randomization; 3. A decrease in morning PEF >=20% from baseline on 3 or more days within any period of 7 consecutive days after randomization; 4. Two or more nights with an awakening due to asthma, which required the use of reliever medication within any period of 7 consecutive days after randomization; 5. A clinical exacerbation requiring emergency treatment, hospitalization, or use of an asthma medication not allowed by the study protocol.

Number of withdrawals due to pre-defined asthma events

Overall Study

The study consisted of a screening visit (Visit 1), an enrollment visit (Visit 2), a 7- to 21-day run-in/qualification period, a randomization visit (Visit 3), and 6 further weekly visits during a treatment period of 6 weeks. A telephone follow-up was conducted approximately 2 weeks after the final study visit.

Arms	Assigned Interventions
Experimental: 1 Budesonide pMDI 160 ug bid (80 ug x 2 inhalations bid)	Drug: budesonide pMDI, inhalation, bid, 6 weeks
Placebo Comparator: 2 Placebo pMDI 2 inhalations bid	Drug: placebo pMDI, inhalation, bid, 6 weeks

A 6-week study in asthmatic children aged 6 to <12 yrs comparing budesonide pMDI 160ug twice daily with placebo - CHASE 1

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

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Actual Enrollment

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Study design

Verification:

Sponsors

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Documents available

CSR synopsis

Trial Results Summaries

Contacts

Contact

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Principal Investigator