A 13 month, randomised, double-blind, parallel-group comparison of the efficacy of Seretide (fluticasone propionate/salmeterol combination Accuhaler) and Flixotide (fluticasone propionate Accuhaler) when down-titrating the inhaled corticosteroid dose in asthmatic adults who have previously received Seretide 500/50 ug twice daily for at least 4 weeks.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000465651

Enrollment

Registered

2005-09-23

Start date

2002-03-21

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Eligible subjects enter a run-in phase and receive open label Seretide Accuhaler 500/50 ug twice daily for 4 weeks. An Electronic Diary Card (EDC) is used twice daily to capture spirometry measurements (PEF & FEV1), asthma symptoms and medication use. Subjects who do not suffer an exacerbation and demonstrate satisfactory use of their EDC will be randomised to receive either flucticasone proprionate (FP) 500 ug twice daily alone or in combination with salmeterol (Seretide) for 8 weeks. Four weeks after randomisation, subjects will return to the clinic (Visit 3) for assessment of their level of asthma control, using the Total Asthma Score (TAS).The TAS is based on asthma symptoms, frequency of Ventolin (salbutamol) use and electronic spirometric monitoring over 4 weeks preceeding a visit. Subjects will then enter the down titration phase of the study and visit the clinic every 8 weeks for 11 months (Visits 4-9). At each visit their eligibility for a step down to a lower dose of FP will be assessed using the TAS. Subjects will be eligible for a dose reduction if their TAS is stable or lower than at the previous visit. Subjects who complete week 52 will be considered to have completed the study.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

Clinical diagnosis of asthma according to the American Thoracic Society for at least 6 months prior to enrolment; prior treatment with Seretide, either by Accuhaler or by MDI (with or without spacer), at a dose of 500/50 ug bd or 250/25 ug 2 inhalations bd, for a minimum of 4 weeks prior to enrolment; willing and able to comply with thetherapy and EDC requirements.Inclusion criteria for randomisation and entry into the down-titration period:Demonstrated ability to comply with the EDC requirements during run-in, plus evidence of adequate unsupervised spirometric technique; no moderate or severe exacerbation(s) in the past 4 weeks.

Exclusion criteria

Current smokers,subjects with a smoking history of >10 pack years or subjects who have given up smoking within 4 weeks prior to Visit 1; use of oral/parenteral or depot corticosteroids within 3 months prior to Visit 1; an acute asthma exacerbation requiring hospital admission within 3 months prior to Visit 1; a respiratory tract infection within the four weeks prior to Visit 1; other significant chronic respiratory disease; evidence of extrathoracic airway obstruction demonstrated by a plateau on the inspiratory flow volume loop at Visit 1; pregnant or lactating women.

Outcome results