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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

Formoterol Fumarate in the Pressair Pressair Dry Powder Inhaler (DPI), Low Dose

Formoterol fumarate in the Pressair Dry Powder Inhaler (DPI), High Dose

The purpose of this Phase II study is to evaluate efficacy and safety of inhaled formoterol fumarate in the Pressair DPI compared to the Foradil Aerolizer in patients with mild to moderate asthma.  
This study will include a screening visit followed by a 4 month treatment period.

Efficacy and Safety Study to Compare Formoterol Fumerate in the Pressair DPI to the Foradil Aerolizer in Patient with Mild to Moderate Asthma

NCT ID

Therapeutic Area

Formoterol Fumarate in the Pressair DPI 6 micrograms, twice a day for 14 days

Formoterol Fumarate in the Pressair DPI 12 micrograms, twice a day for 14 days

Foradil Aerolizer 12 micrograms, twice a day for 14 days

Foradil Aerolizer 24 micrograms, twice per day for 14 days

Forest Investigative Site 909

Forest Investigative Site 1134

Forest Investigative Site 1137

Forest Investigative Site 1153

Forest Investigative Site 1155

Forest Investigative Site 1176

Forest Investigative Site 1332

Forest Investigative Site 1333

Forest Investigative Site 1347

Forest Investigative Site 1370

Forest Investigative Site 1431

Forest Investigative Site 1536

Forest Investigative Site 1599

Forest Investigative Site 1580

Forest Investigative Site 1609

Forest Investigative Site 1624

Forest Investigative Site 1699

Forest Investigative Site 1806

Forest Investigative Site 1995

Forest Investigative Site 1996

Forest Investigative Site 1997

Forest Investigative Site 1998

Forest Investigative Site 1999

Forest Investigative Site 2011

Forest Investigative Site 2025

Forest Investigative Site 2041

Forest Investigative Site 2043

Forest Investigative Site 2047

Forest Investigative Site 2066

Phase II, Randomized, Placebo-controlled, Double-blind, Double-dummy, 5-period Complete Crossover study of the Bronchodilator Effects of Formoterol Fumarate Inhalation Powder in Patients with Mild to Moderate Asthma.

Change from baseline in normalized FEV1 Area Under the Curve (AUC) from time 0 to 6 hours (AUC 0h-6h) after the morning dose of investigational product at Day 14 across treatment periods.

Age Continuous

Gender, Male/Female

AUC0-6 is area under the curve from time 0 to 6 hours 
Serial spirometry was performed at -60 min predose, at 5 (+5) and 30 (±5) min post-dose, and at 1, 2, 3, 4, and 6 hrs post-dose (±15 min)
Change from baseline was baseline of each treatment period
The normalized FEV1 AUC0-6 was calculated by means of the trapezoidal method, dividing the area under the curve by the corresponding time intervals

Intent to treat (ITT) Population defined as all patients in the Safety Population who had a baseline and at least 1 post-baseline FEV1 assessment

Change from baseline in normalized forced expiratory volume in one second (FEV1) AUC0-6 after the morning dose (Day 14)

AUC0-6 is area under the curve from time 0 to 6 hours 
Serial spirometry was performed at -60 min predose, at 5 (+5) and 30 (±5) min post-dose, and at 1, 2, 3, 4, and 6 hrs post-dose (±15 min)
Change from baseline was baseline of Period 1
The time-normalized FEV1 AUC0-6 was calculated by means of the trapezoidal method, dividing the area under the curve by the corresponding time intervals

Change from baseline in normalized FEV1 AUC0-6 after the morning dose (Day 1)

Period 1

Period 2

Period 3

Period 4

Period 5

A total of 408 patients were screened; there were 234 screen failures, primarily (225/234) because inclusion/exclusion criteria were not met

Study Director

The secondary efficacy parameters are change from baseline in normalized FEV1 area under the curve from time 0 to 6 hours (AUC 0h-6h) after the morning dose of investigational product at Day 1 across treatment periods and change from baseline in FEV1 at each specific time point at Days 1 and 14 across treatment periods.

Number of patients to experience a Treatment Emergent Adverse Event (TEAE)

Number of patients to experience a potentially clinically significant (PCS) change in pulse rate, systolic and diastolic blood pressure, body temperature or body weight

Number of patients to experience potentially clinically significant changes in ECG from Baseline.

Number of patients to experience a potentially clinically significant (PCS) change in clinical laboratory values for Hematology, Chemistry or Urinalysis.

Arms	Assigned Interventions
Experimental: Experimental 1 Formoterol Fumarate in the Pressair Pressair Dry Powder Inhaler (DPI), Low Dose	Drug: Formoterol Fumarate in the Pressair DPI, Low Dose Formoterol Fumarate in the Pressair DPI 6 micrograms, twice a day for 14 days
Experimental: Experimental 2 Formoterol fumarate in the Pressair Dry Powder Inhaler (DPI), High Dose	Drug: Formoterol Fumarate in the Pressair DPI, High Dose Formoterol Fumarate in the Pressair DPI 12 micrograms, twice a day for 14 days
Active Comparator: Active Comparator 1 Foradil Aerolizer, Low Dose	Drug: Foradil Aerolizer, Low Dose Foradil Aerolizer 12 micrograms, twice a day for 14 days Other Name: Formoterol
Active Comparator: Active Comparator 2 Foradil Aerolizer, High Dose	Drug: Foradil Aerolizer, High Dose Foradil Aerolizer 24 micrograms, twice per day for 14 days Other Name: Formoterol
Placebo Comparator: Placebo Dose matched placebo	Drug: Placebo Placebo in the Pressair for 14 days

Efficacy and Safety Study to Compare Formoterol Fumerate in the Pressair DPI to the Foradil Aerolizer in Patient with Mild to Moderate Asthma

Official Title

Medical condition

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Documents available

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