Rajanandh 2014.

Methods	Study design: RCT Study grouping: parallel group Open label: yes Cluster RCT: no
Participants	Baseline characteristics LAMA add‐on N umber randomised: 42 N umber completed: 31 Mean age (SD): 40.4 (13.6) years % Male: 64.5 % Predicted FEV1 (SE): 66.9 (1.65) % White: NR Duration of asthma (SD): 5.4 (2.7) years LABA add‐on Number randomised: 42 N umber completed: 32 Mean age (SD): 37.2 (14.9) years % Male: 56.3 % Predicted FEV1 (SE): 66.6 (1.99) % White: NR Duration of asthma (SD): 5.6 (2.7) years Inclusion criteria: aged 18‐60 years; clinically diagnosed as having mild‐to‐moderate persistent asthma Improvement in FEV1 > 12% after bronchodilator inhalation; written informed consent Exclusion criteria: clinically significant renal, respiratory (other than asthma), cardiac, gastrointestinal, hepatic, endocrine or haematological disorders; cancer; unresolved upper respiratory tract infection within the past 3 weeks; suspected hypersensitivity to study therapy or excipients; pregnancy or lactation; any other concurrent illness; any major surgery; and receipt of any oral, inhaled or parenteral forms of corticosteroid during the month before the study
Interventions	Intervention characteristics LAMA add‐on ICS type/dose: budesonide 400 mcg Add‐on type/dose: tiotropium 18 mcg once daily Co‐medications: participants were excluded if they had taken any oral, inhaled or parenteral forms of corticosteroid during the month before the study. All the recruited participants received inhaled salbutamol 200 mg as a rescue medication during their run‐in period and throughout the study whenever necessary (total daily dose 800 mcg) Type of inhaler: HandiHaler Duration of treatment: 3 months LABA add‐on ICS type/dose: budesonide 400 mcg Add‐on type/dose: formoterol 12 mcg twice daily Co‐medications: participants were excluded if they had taken any oral, inhaled or parenteral forms of corticosteroid during the month before the study. All the recruited participants received inhaled salbutamol 200 mg as a rescue medication during their run‐in period and throughout the study whenever necessary (total daily dose 800 mcg) Type of inhaler: dry powder inhaler Duration of treatment: 3 months
Outcomes	Continuous Trough FEV1 (L) ‐ summarised narratively Rescue medication (puffs/day) ‐ not a pre‐specified outcome of this review No dichotomous outcomes reported
Identification	Sponsorship source: SRM University Country: India Setting: Department of Pulmonary Medicine, SRM Medical College Hospital and Research Centre Registration ID: CTRI/2012/08/002915. This is a pilot study for a subsequent paper that is as yet not fully published. Authors name: Muhasaparur G. Rajanandh Institution: SRM College of Pharmacy, Tamil Nadu, India Email: mgrpharm@gmail.com Address: SRM College of Pharmacy, SRM University, Kattankulathur, Chennai, Kancheepuram, TAMIL NADU603 203, India
Notes	Pre‐treatment: "No significant differences in baseline characteristics were found between the groups (P>0.05)" This is a PILOT STUDY for a subsequent paper which is as yet not fully published
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	A randomisation list was generated using Random allocation software, version 1.0
Allocation concealment (selection bias)	Low risk	"Concealment of optimization codes was done by serially numbered, opaque envelope model" Envelopes were sealed (CTRI website)
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open‐label
Blinding of outcome assessment (detection bias) All outcomes	High risk	Open‐label. No description of measures taken to blind outcome assessors
Incomplete outcome data (attrition bias) All outcomes	High risk	"Per protocol analysis was performed." Those that did not complete the trial were not included in the analyses (over 25% of the total population)
Selective reporting (reporting bias)	Unclear risk	The main trial was retrospectively registered (CTRI/2012/08/002915) but the planned outcomes of the pilot study are not detailed. Lung function and rescue medication were the main focus of the paper and were well reported
Other bias	Low risk	None noted