SERETIDE Vs FLIXOTIDE In Mild Persistent Asthma (GINAII)

NCT00455923 | Completed Phase 4 Results

• 1 other identifier: SAM103976
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

An 18 months randomised double-blind study with two parallel arms with start dose of inhaled SERETIDE 50/100mcg BD or FLIXOTIDE 100mcg BD, Phase I is 6 months where the patient will be up-titrated until well controlled is achieved, After 6 months the treatment continues without changes during 9 months = PhaseII. The aim is to investigate and evaluate the assumption that the combination therapy with SERETIDE controls mild persistent asthma better than inhaled corticosteroids(FLIXOTIDE) alone.

Conditions

Asthma

Keywords

asthma; exacerbation; persistent; bronchial hyperresponsiveness; mild; GINAII

Outcome Measures

Primary Outcomes (1)

• Number of Participants in Each Arm With a Need for an Increase in Study Medication

  During the first 6 months, when the asthma was unstable/uncontrolled, dose of Seretide (Sal/FP) was increased from 50/100 mcg in a stepwise fashion to 50/250 mcg and 50/500 mcg (if still unstable). Also, dose of Flixotide (FP only), was increased from 100 mcg to 250 mcg and 500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months. Number of participants in each arm with a need for an increase in study medication are presented.

  Up to 18 months

Secondary Outcomes (5)

• Absolute Bronchial Hyper-responsiveness up to 18 Months

  Up to 18 months

• Change in Bronchial Hyper-responsiveness From Baseline to 18 Months

  Baseline (Day 0) to 18 months

• Number of Symptom-free Days and Nights Without Use of Rescue Medication

  Up to 18 months

• Number of Exacerbations: in Total and by Degree of Severity

  Up to 18 months

• Time to Increase of Study Medication

  Up to 6 months

Study Arms (2)

Seretide

EXPERIMENTAL

Eligible participants received a starting dose of 50/100 mcg Seretide (combination of Sal/FP) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 50/250 mcg and 50/500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months.

Drug: Seretide

Flixotide

EXPERIMENTAL

Eligible participants received a starting dose of 100 mcg Flixotide (FP only) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 250 mcg and 500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months.

Drug: Flixotide

Interventions

Seretide DRUG

Seretide

Seretide

Flixotide DRUG

Flixotide

Flixotide

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to give informed consent.
• Males or females aged 18-70.
• Able to understand and complete dairy cards.
• Mild persistent asthma according to GINA. In addition, at randomisation subjects were required to have: 1. Day time symptoms more than once a week but not every day. 2. Night-time symptoms not more than once a week. 3. FEV1 \>80% predicted 4. PC20 \<8mg/mL

You may not qualify if:

• Change to regular asthma medication in 4-weeks prior to visit 1.
• Use of oral, depot or parenteral corticosteroids within 8 weeks of visit 1.
• Lower respiratory tract within 4 weeks of Visit 1
• Received investigational study drug within 4 weeks of visit
• Smoking history of \>10 pack years of more.
• Serious uncontrolled disease.
• Medical conditions or medications known to affect the assessments or endpoints.
• Evidence of alcohol or drug abuse.
• Known pregnancy or planned pregnancy.
• Known or suspected hypersensitivity to inhaled corticosteroids, beta-agonists or lactose.
• Previous enrollment in the study

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Luleå, SE-971 89, Sweden

Location

MeSH Terms

Conditions

Asthma; Bronchial Hyperreactivity; Lymphoma, Follicular

Interventions

Fluticasone-Salmeterol Drug Combination; Fluticasone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders

Intervention Hierarchy (Ancestors)

Salmeterol Xinafoate; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2007
• First Posted: April 4, 2007
• Study Start: May 3, 2005
• Primary Completion: July 31, 2007
• Study Completion: July 31, 2007
• Last Updated: February 5, 2018
• Results First Posted: January 4, 2018

Record last verified: 2018-01

Locations

SE (1)