Clinical Trials Logo
  1. Home
  2. Asthma
  3. NCT00169546
  4. Details
NCT00169546 Clinical Trial

Study In Airway Physiology In Children SERETIDE DISKUS ® Inhlaer and FLIXOTIDE® Inhaler Are Trademarks of GSK Group of Companies.

Asthma Clinical Trial

Official title:
Randomised, Double-blind Parallel Group Study to Assess the Bronchodilative and Bronchoprotective Properties of SERETIDE DISKUS ® Inhlaer 50/100mcg Twice Daily vs. FLIXOTIDE® Inhaler 200mcg Twice Daily.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00169546
Other study ID # SAM40100
Secondary ID
Status Completed
Phase Phase 4
First received September 9, 2005
Last updated September 13, 2016
Start date January 2003
Est. completion date December 2005

Study information
Verified date September 2016
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory AgencyNew Zealand: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Comparison of two asthma treatments by lung function measures.

Recruitment information / eligibility
Status Completed
Enrollment 64
Est. completion date December 2005
Est. primary completion date December 2005
Accepts healthy volunteers No
Gender Both
Age group 4 Years to 11 Years
Eligibility Inclusion criteria:

- Currently receiving 200-800mcg/day beclomethasone dipropionate.

- sRAW value of 1.3 kPa's.

Exclusion Criteria:

- 3 or more courses of oral steroids in last 12 months.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Salmeterol/fluticasone propionate

• Fluticasone propionate

Locations
Country Name City State
New Zealand GSK Investigational Site Wellington
United Kingdom GSK Investigational Site Manchester Lancashire

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

New Zealand,  United Kingdom, 

References & Publications (1)

This study has not been published in the scientific literature.

Outcome
Type Measure Description Time frame Safety issue
Primary sRAW (k.Pa.s) measured before the study medication dose at the end of treatment (week 6)
Secondary sRAW measured pre-dose at Week 3. sRAW measured 48 hours after last study medication dose. % symptom-free days over Weeks 1-6. % symptom-free nights over Weeks 1-6. Type and frequency of adverse events.
See also
  Status Clinical Trial Phase
Terminated NCT04410523 - Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma Phase 2
Completed NCT04624425 - Additional Effects of Segmental Breathing In Asthma N/A
Active, not recruiting NCT03927820 - A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR) N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT03694158 - Investigating Dupilumab's Effect in Asthma by Genotype Phase 4
Terminated NCT04946318 - Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma Phase 2
Completed NCT04450108 - Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients N/A
Completed NCT03086460 - A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH) Phase 2
Completed NCT01160224 - Oral GW766944 (Oral CCR3 Antagonist) Phase 2
Completed NCT03186209 - Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE) Phase 3
Completed NCT02502734 - Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma Phase 3
Completed NCT01715844 - L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics Phase 1
Terminated NCT04993443 - First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036 Phase 1
Completed NCT02787863 - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology Phase 4
Recruiting NCT06033833 - Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study Phase 2
Completed NCT03257995 - Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma. Phase 2
Completed NCT02212483 - Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients N/A
Recruiting NCT04872309 - MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
Withdrawn NCT01468805 - Childhood Asthma Reduction Study N/A
Recruiting NCT05145894 - Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device

External Links